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Approaches to Support Ventricular Assist Device Patients in the Community : a Scoping Review Bagtas, Ninianne Alexis 2018-08

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	APPROACHES	TO	SUPPORT	VENTRICULAR	ASSIST	DEVICE	PATIENTS	IN	THE	COMMUNITY:	A	SCOPING	REVIEW			by	NINIANNE	ALEXIS	BAGTAS	B.Sc.N.,	The	University	of	British	Columbia,	2007			A	SPAR	PROJECT	SUBMITTED	IN	PARTIAL	FULFILLMENT		OF	THE	REQUIREMENTS	FOR	THE	DEGREE	OF				MASTER	OF	SCIENCE	IN	NURSING	in		THE	FACULTY	OF	GRADUATE	AND	POSTDOCTORAL	STUDIES			THE	UNIVERSITY	OF	BRITISH	COLUMBIA		(Vancouver)			August	2018	©	Ninianne	Alexis	Bagtas,	2018			 ii	Committee		The	following	individuals	certify	that	they	have	read,	and	recommend	to	the	Faculty	of	Graduate	and	Postdoctoral	Studies	for	acceptance,	a	SPAR	project	entitled:		Approaches	to	Support	Ventricular	Assist	Device	Assist	Patients	in	the	Community:	a	Scoping	Review		submitted	by	 Ninianne	Alexis	Bagtas	 	 in	partial	fulfillment	of	the	requirements	for	the	degree	of	 Master	of	Science	in	Nursing	in	 The	Faculty	of	Graduate	and	Postdoctoral	Studies		Examining	Committee:	Dr.	Bernie	Garrett,	Nursing	Supervisor		Annemarie	Kaan,	Nursing	Supervisory	Committee	Member							 																	 iii	Abstract		Ventricular	Assist	Devices	(VADs)	are	internally	implanted	mechanical	circulatory	pumps	designed	to	augment	cardiac	function	in	patients	with	end-stage	heart	failure.		These	devices	offer	significant	improvements	in	mortality	and	quality	of	life	when	compared	to	medical	management	alone.		However	the	complexities	of	the	device	require	specialized	management	even	when	patients	are	discharged	from	hospital.		In	response	mechanical	circulatory	support	(MCS)	centres	have	developed	a	number	of	approaches	to	support	patients	living	in	the	community	along	with	their	caregivers	and	community	healthcare	providers.		However	the	nature	and	effectiveness	of	these	approaches	are	unclear.		A	five-stage	scoping	review	was	conducted	to	identify	the	range,	characteristics,	and	effectiveness	of	support	approaches	that	have	been	reported.		The	theory	of	self-care	of	chronic	illness	was	used	to	guide	the	analysis.		CINAHL,	PubMed/MEDLINE,	the	Web	of	Science,	and	Google	Scholar	were	used	to	identify	17	studies.		Studies	were	eligible	for	inclusion	if	they	included	a	sample	VAD	patients,	their	caregivers,	or	their	community	healthcare	providers,	included	an	approach	to	outpatient	care,	and	were	delivered	outside	of	the	MCS	centre.		Seven	themes	were	identified.		MCS	team	support,	close	surveillance,	resource	provision,	community	provider	as	support,	provider	training,	peer	support,	and	educating	family	and	friends	represent	the	range	of	community	support	approaches	reported	in	the	literature.		The	principles	of	MCS	centres	as	hubs	of	support,	emergency	preparedness,	and	the	use	of	novel	technologies	characterize	these	approaches.		These	themes	offer	nurses	and	other	MCS	clinicians	a	catalogue	of	approaches	to	support	the	self-care	of	these	patients	in	the		 iv	community,	as	well	as	potential	inspiration	for	the	development	and	study	of	future	community	support	initiatives	for	VAD	patients,	their	families,	and	their	community	healthcare	providers.						 v	Lay	Summary	A	Ventricular	Assist	Device	(VAD)	is	a	type	of	mechanical	heart	pump.		It	is	implanted	to	help	people	with	failing	hearts	to	pump	enough	blood	through	their	body.		This	pump	helps	people	to	return	to	some	of	their	normal	activities,	and	to	go	home	from	the	hospital.		Even	when	they	are	home,	people	implanted	with	VADs	need	extra	support	to	take	care	of	them.		The	purpose	of	this	study	was	to	find	all	the	different	ways	to	provide	this	extra	support,	and	which	ways	might	work	best.		The	research	was	searched	and	organized	to	answer	these	questions.		These	answers	are	meant	to	help	nurses	and	other	healthcare	workers	to	improve	care	to	support	people	implanted	with	VADs.				 vi	Preface	This	SPAR	project	is	original,	unpublished,	independent	work	by	the	author,	N.	Bagtas.				 vii	Table	of	Contents	Abstract		........................................................................................................................................................	iii	Lay	Summary		..............................................................................................................................................	v	Preface		..........................................................................................................................................................	vi	List	of	Tables		................................................................................................................................................	x	List	of	Figures		............................................................................................................................................	xi	Chapter	1:		Introduction		........................................................................................................................	1	Background	....................................................................................................................................	1	Ventricular	Assist	Devices	.......................................................................................................	2	Potential	Complications	...........................................................................................................	4	Outpatient	Surveillance	............................................................................................................	6	The	Challenges	of	Outpatient	Care	......................................................................................	8	Support	Approaches	................................................................................................................	10	Benefits	of	Community	Management	...............................................................................	10	Rationale	.......................................................................................................................................	11	Research	Questions	..................................................................................................................	12	Conceptual	Framework	..........................................................................................................	12	Study	Significance	.....................................................................................................................	14	Chapter	2:		Methods		...............................................................................................................................	15	Scoping	Review	..........................................................................................................................	15	Stage	I:		Identifying	the	Research	Question	...................................................................	16		 viii	Stage	II:		Identifying	Relevant	Studies	..............................................................................	17	Stage	III:		Study	Selection	.......................................................................................................	17	Inclusion	Criteria	.......................................................................................................................	18	Exclusion	Criteria	......................................................................................................................	19	Stage	IV:		Charting	the	Data	..................................................................................................	20	Stage	V:		Collating,	Summarizing,	and	Reporting	the	Results	................................	22	Quality	Assessment	..................................................................................................................	24	Chapter	3:		Results		..................................................................................................................................	25	Search	and	Screening	Results	..............................................................................................	25	Descriptive	and	Numerical	Summary	..............................................................................	26	Review	Findings	.........................................................................................................................	29	Conceptual	Framework	..........................................................................................................	37	Interventional	Effectiveness	.................................................................................................	41	Quality	Assessment	..................................................................................................................	47	Chapter	4:		Discussion		..........................................................................................................................	57	Reported	Approaches	..............................................................................................................	57	Approach	Characteristics	and	Contexts	..........................................................................	58	Approach	Effectiveness	..........................................................................................................	61	Study	Limitations	......................................................................................................................	64	Chapter	5:		Conclusions		........................................................................................................................	65	Future	Research	.........................................................................................................................	65	Implications	for	Nursing	Practice	......................................................................................	69		 ix	Nursing	Research	......................................................................................................................	70	Knowledge	Translation	..........................................................................................................	70	Summary	.......................................................................................................................................	71	References		..................................................................................................................................................	72			 x	List	of	Tables	Table	1.		Site	and	sample	features	of	the	17	studies	Table	2.		Frequency	of	support	approaches	reported	within	the	17	studies	Table	3.		The	self-care	processes	of	chronic	illness	as	the	focus	of	reported	community	support	approaches	within	the	17	studies	Table	4.		Outcomes	and	key	findings	around	community	support	approaches	within	the	17	studies	Table	5.		Methodological	strengths	and	weaknesses	of	the	17	studies			 xi	List	of	Figures	Figure	1.		Model	of	the	theory	of	self-care	of	chronic	illness	adapted	for	VAD	patients	Figure	2.		Flowchart	of	the	study	search	and	selection	process	Figure	3.		Study	distribution	by	country	Figure	4.		Study	distribution	by	year	of	publication		 1	Chapter	1:	Introduction	While	the	sophistication	of	mechanical	circulatory	support	(MCS)	systems	have	extended	life	in	selected	patients	with	advanced	and	end-stage	heart	failure	(ESHF),	heart	failure	incidence	and	severity	in	Canada	continue	to	increase	(Heart	and	Stroke	Foundation,	2016;	Schmitto	et	al.,	2016).		Coupled	with	the	limited	availability	of	donor	hearts,	the	need	for	and	prevalence	of	MCS	systems	is	only	expected	to	grow.		As	a	form	of	MCS,	Ventricular	Assist	Devices	(VADs)	are	a	durable	and	effective	treatment	to	provide	cardiac	support	to	selected	patients	with	advanced	heart	failure.			Improved	device	safety	and	patient	management	have	established	outpatient	management	as	the	standard	of	care.		However	the	complexity	of	outpatient	management	has	required	MCS	centres	to	develop	varied	approaches	to	support	VAD	care	in	the	community.		This	scoping	review	examines	the	range	of	approaches	currently	reported	in	use	to	support	the	management	of	VAD	patients	in	the	community	setting.		The	theory	of	self-care	of	chronic	illness	will	guide	this	analysis	of	the	research	in	this	emerging	field.				Background	Heart	failure	“is	a	complex	clinical	syndrome	in	which	abnormal	heart	function	results	in…clinical	symptoms	of	reduced	cardiac	output…at	rest	or	with	stress”	(Ezekowitz	et	al.,	2017,	p.	1343).		A	“persistent	and	progressive	disease”,	heart	failure	is	punctuated	by	episodic	decompensation	and	includes	“symptoms…of	reduced	cardiac	output”	such	as	shortness	of	breath,	chest	pain,	fatigue,	and	signs	of		 2	end-organ	hypoperfusion	(Ezekowitz	et	al.,	2017,	p.	1343;	Yancy	et	al.,	2013).		These	may	evolve	to	severely	limit	functional	ability	and	quality	of	life.			In	Canada,	50,000	new	cases	of	heart	failure	are	diagnosed	annually,	while	26	million	people	are	affected	worldwide	(Heart	and	Stroke	Foundation,	2016;	Ambrosy	et	al.,	2014).		The	disease	is	estimated	to	cost	Canadians	$2.8	billion	in	direct	costs	including	hospital	services,	medications,	and	follow-up	care	each	year—an	estimate	which	fails	to	include	the	indirect	costs	due	to	lost	productivity,	illness	benefits	and	welfare	support	(Cook	et	al.,	2014;	Heart	and	Stroke	Foundation,	2016).		Globally	the	combined	cost	(direct	and	indirect)	of	heart	failure	is	estimated	to	be	$108	billion	per	annum	(Cook	et	al.,	2014).			Despite	medical	therapy	patients	frequently	experience	ongoing	and	sometimes	acute	cardiac	decompensation.		Some	of	these	patients	may	be	suitable	for	consideration	for	heart	transplant,	or	more	recently,	specialized	cardiac	technologies,	to	sustain	and	prolong	their	life	(Yancy	et	al.,	2013).		Heart	transplantation	is	the	consensus	long-term	therapy	for	heart	failure	(Schmitto	et	al.,	2016).		However,	as	Schmitto	et	al.	(2016)	note,	the	limited	supply	of	organs	for	donation	worldwide	restricts	this	as	a	treatment	option	for	many	patients.		In	light	of	these	shortages,	alternatives	to	heart	transplant	have	been	developed	since	the	1960s,	in	the	form	of	mechanical	circulatory	support	(MCS)	technologies	(Rose	et	al.,	2001).			Ventricular	Assist	Devices	Ventricular	Assist	Devices	(VADs)	offer	MCS	to	selected	patients	with	heart	failure	requiring	long-term	support	(Cook	et	al.,	2017;	Schmitto	et	al.,	2016).		VADs		 3	in	current	use	are	internally	implanted	electromechanical	pumps	designed	to	augment	cardiac	output	and	maintain	organ	perfusion	(Wilson,	Givertz,	Stewart,	&	Mudge,	2009).		They	are	most	often	implanted	surgically	via	steronotomy,	usually	during	cardiopulmonary	bypass	(Wilson	et	al.,	2009).		The	pump	draws	blood	from	the	ventricle	and	pushes	it	through	to	the	aorta	(Wilson	et	al.,	2009).		The	‘driveline’	is	an	electrical	wire	that	exits	through	the	skin,	connecting	the	pump	to	the	external	controller	and	two	external	power	sources,	in	the	form	of	specialized	batteries	and/or	connection	to	AC	or	DC	power	(Cook	et	al.,	2017).					 VADs	provide	cardiac	support	to	patients	with	heart	failure	awaiting	heart	transplant	(bridge	to	transplant),	as	a	bridge	to	cardiac	recovery,	or	as	a	permanent	support	for	selected	patients	with	ESHF,	but	ineligible	for	heart	transplant	(destination	therapy)	(Cook	et	al.,	2017;	Schmitto	et	al.,	2016).		By	providing	continuous	flow,	VADs	support	cardiac	output.		This	support	is	commonly	provided	to	the	left	ventricle	alone,	but	the	device	is	capable	of	providing	right-sided	or	biventricular	support.		This	support	decreases	myocardial	workload	and	thereby	in	some	cases	promotes	recovery	(MacIver	et	al.,	2009;	Wilson	et	al.,	2009).		VADs	have	provided	significant	improvements	in	mortality	and	quality	of	life	for	patients	with	ESHF	when	compared	to	medical	therapy	alone	(Rose	et	al.,	2001).		Survival	rates	of	patients	implanted	with	current	continuous	flow	devices	hover	around	80%	at	one	year	and	70%	at	two,	with	reports	of	survival	rates	near	60%	at	five	years	(Kirklin	et	al.,	2017;	Schmitto	et	al.,	2016).		These	numbers	highlight	the	growing	number	of	years	patients	are	living	on	VAD	support—with	a	significant	cohort	of	patients	living	beyond	their	fourth	year	of	support	(Schmitto	et	al.,	2016).			 4	In	addition	to	years	of	life,	patients	supported	with	VAD	report	substantial	improvements	in	physical	function	and	quality	of	life	(Jakovljevic	et	al.,	2014;	Kirklin	et	al.,	2017).		These	changes	often	occur	within	the	first	three	months	following	implantation,	as	patients	report	improvements	in	their	ability	to	conduct	self-care	and	their	usual	activities,	as	well	as	marked	improvement	in	their	overall	health	(Jakovljevic	et	al.,	2014;	Kirklin	et	al.,	2017).		Such	improvements	allow	many	patients	to	return	to	work	or	school	(Morales	et	al.,	2000;	Wilson	et	al.,	2009).			Potential	Complications	While	VADs	provide	a	safe	and	effective	form	of	cardiac	support,	significant	complications	sometimes	occur.		The	surfaces	of	the	VAD	and	the	shear	forces	affected	by	its	flow	can	cause	activation	of	immune	system	and	coagulation	factors	(Wilson	et	al.,	2009).		Activation	of	these	factors	can	cause	bleeding	as	well	as	clot	formation	or	pump	thrombosis	resulting	in	stroke	or	device	failure	(Wilson	et	al.	2009).		While	antiplatelet	and	anticoagulation	therapies	are	required	for	the	duration	of	VAD	support	to	minimize	these	risks,	this	must	be	also	weighed	against	the	risk	of	bleeding	(Wilson	et	al.,	2009).				Early	complications	related	to	VAD	implantation	are	typically	related	to	the	surgical	implantation	itself.		Common	complications	during	the	30	days	post	implantation	include	bleeding	and	infection	(Kirklin	et	al.,	2017).		However	many	patients	experience	non-surgical	bleeding	post	implantation,	with	gastrointestinal	(GI)	bleeding	reported	as	the	leading	cause	of	readmission	within	the	first	month	(Akhter	et	al.,	2015).		A	number	of	factors	have	been	implicated	in	this	increased	risk	including	acquired	von	Willebrand	syndrome,	vascular	alterations	caused	by		 5	the	device’s	non-pulsatile	flow,	and	the	accompanying	risk	of	bleeding	arising	from	antiplatelet	and	anticoagulation	therapies	(Akhter	et	al.,	2015).		During	the	early	post	implantation	period	multisystem	organ	failure,	right	heart	failure,	and	cerebrovascular	events	(embolic	or	haemorrhagic)	confer	the	greatest	risks	of	mortality	(Kirklin	et	al.,	2017).	Long-term	complications	of	VAD	therapy	include	cerebrovascular	events,	bleeding,	and	infection	(Kirklin	et	al.,	2017;	Schmitto	et	al.,	2016).		Kirklin	et	al.	(2017)	note	that	beyond	6	months	post	implantation,	stroke	persists	as	the	primary	cause	of	death.		Unfortunately	the	risk	of	stroke	exists	both	from	thrombus	formation	as	well	as	haemorrhage.		Balancing	the	need	for	anticoagulation	with	the	risk	of	bleeding	(particularly	since	MCS	patients	appear	to	be	susceptible	to	GI	bleeding)	is	an	ongoing	challenge	of	VAD	management	(Wilson	et	al.,	2009).		Outside	of	bleeding	within	the	first	3	months,	infection	is	the	most	frequent	adverse	event	(Kirklin	et	al.,	2017).		The	driveline	exit	site	is	vulnerable	to	infection,	and	the	risk	exists	that	this	may	become	a	potentially	serious	complication	leading	to	sepsis	or	multiorgan	failure	(Schmitto	et	al.,	2016;	Wilson	et	al.,	2009).		While	pump	thrombus	and	related	malfunction	are	relatively	infrequent	complications,	rates	of	device	thrombosis	are	higher	than	originally	reported	(Kirklin	et	al.	2015;	Uriel	et	al.,	2014).		Pump	thrombus	can	result	in	various	thromboembolic	events	as	well	as	hemodynamic	collapse	and	death	(Uriel	et	al.,	2014).		Treatment	for	thrombus	includes	heparin,	fibrinolytic	therapy	or	pump	exchange	(Uriel	et	al.,	2014).		Unsurprisingly,	survival	worsens	with	each	pump	exchange	(Kirklin	et	al.,	2015).					 6	Outpatient	Surveillance	Historically	patient	frailty	and	the	higher	complication	rate	of	first	generation	devices	necessitated	ongoing	proximity	to	the	MCS	centre	for	rapid	care	management	after	hospital	discharge	(Helman	&	Oz,	2001;	Morales	et	al.	2000).		The	transition	in	device	design	from	early	pulsatile	devices	to	more	sophisticated	current	continuous	flow	pumps	has	markedly	decreased	the	risk	of	mechanical	device	malfunction	(Pagani	et	al.,	2009).			Improved	durability	and	patient	outcomes,	along	with	increasing	program	expertise	(such	as	patient	selection	and	timing	of	implantation),	has	established	the	safety	of	outpatient	VAD	management	such	that	it	has	become	the	standard	of	care	(Morales	et	al.,	2000;	Wilson	et	al.,	2009).		As	such	the	majority	of	patients	are	able	to	return	to	their	home	communities	upon	discharge	(Schlöglhofer	et	al.,	2016).		Routine	care	now	involves	outpatient	clinic	visits	to	the	MCS	centre	at	regular	and	lengthening	intervals	(MacIver	et	al.,	2009).		Still,	the	dynamics	of	the	technology	remain	complex,	and	require	significant	preparation	while	the	patient	is	still	hospitalized	to	ensure	safe	management	as	an	outpatient.		Foremost	is	the	designation	of	a	caregiver	(Marcuccilli	&	Casida,	2011).		Prior	to	discharge,	both	the	patient	and	their	caregiver	are	required	to	master	device-specific	care	(Feldman	et	al.,	2013;	Widmar,	Dietrich,	&	Minnick,	2014).		This	includes	daily	management	such	as	changing	power	sources,	driveline	site	care	and	emergency	procedures	(Widmar	et	al.,	2014).		While	caregiving	requirements	vary	across	hospitals,	the	caregiver	is	generally	responsible	for	providing	many	aspects	of	day-to-day	care	for	the	patient	once	discharged	(Magid	et	al.,	2016;	Marcuccilli	&		 7	Casida,	2011).		Caregivers	are	also	required	to	assist	patients	with	postoperative	recovery,	medication	management,	and	coordination	of	follow-up	appointments	and	transport	(Magid	et	al.,	2016;	Marcuccilli	&	Casida,	2011).		The	intensity	and	duration	of	caregiving	varies	considerably	according	to	the	patient’s	condition—as	patients	become	more	independent,	caregiving	requirements	lessen	(Magid	et	al.,	2016).		Follow-up	occurs	at	the	MCS	centre	for	heart	failure	and	device-related	examination	(MacIver	et	al.,	2009).		Clinic	visits	include	a	thorough	history,	symptom	review,	and	physical	exam,	as	well	as	a	review	of	anticoagulation	and	blood	pressure	control	parameters	in	the	clinic	(Estep,	Trachtenberg,	Loza,	&	Bruckner,	2015).		Managing	anticoagulation	with	the	risk	of	bleeding	can	be	challenging,	and	regular	laboratory	testing	and	medication	titration	are	required	(Estep	et	al.,	2015).		Unfortunately	there	is	no	standardized	regimen	for	anticoagulation	as	practices	vary	across	programs	(Schmitto	et	al.,	2016).		Hypertension	management	is	often	required	as	patients	frequently	develop	post	implantation	hypertension	(Mountis	&	Starling,	2009).		The	pump’s	dependence	on	higher	preload	and	lower	afterload	requires	tight	blood	pressure	control	(MAP	between	70	to	80)	to	promote	optimum	forward	flow	(Estep	et	al.,	2015).		Maintaining	blood	pressure	in	this	range	is	also	important	to	minimize	the	risk	of	end-organ	damage	and	cerebral	bleeding	(Estep	et	al.,	2015;	Mountis	&	Starling,	2009).					 8	The	Challenges	of	Outpatient	Care	Though	VAD	patients	are	now	living	with	their	devices	for	months	and	even	years,	living	in	the	community	still	poses	distinct	challenges	for	patients	with	VADs,	their	caregivers,	and	their	community	healthcare	providers.			Patient	experiences.		For	many	patients	learning	to	manage	the	complexity	of	VAD	care	is	challenging.		The	transition	home	is	often	characterized	by	uncertainty,	persistent	worry,	and	a	lack	of	perceived	control	(Hallas,	Banner,	&	Wray	2009;	Marcuccilli,	Casida,	Bakas,	&	Pagani,	2014).		As	a	result	many	patients	experience	depression	and	anxiety	(Marcuccilli	et	al.,	2014).		Even	after	mastering	VAD	care	in	hospital,	many	patients	doubt	their	ability	to	execute	these	skills,	and	fear	going	home	(Casida,	Marcuccilli,	Peters,	&	Wright,	2011;	Magid	et	al.	2016).		VAD	therapy	requires	patients	to	make	substantial	adjustments	to	their	daily	lives—from	physical	alterations	to	the	home	environment	to	changes	in	daily	activities	to	accommodate	the	device	(Casida	et	al.,	2011).		Showering	is	one	activity	that	is	markedly	altered.		The	device	must	never	get	wet,	and	despite	specialized	showering	equipment	frequently	requires	assistance	to	accomplish	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017).				Caregiver	burden.		VAD	caregivers	report	similar	experiences	of	pervasive	worry,	self-doubt	around	caregiving,	and	feeling	overwhelmed	(Marcuccilli	et	al.,	2014).		This	is	unsurprising	as	responsibility	for	caregiving	often	commences	with	the	patient’s	postoperative	recovery,	when	the	patient	is	most	dependent.		Over	time	caregiving	itself	may	become	a	chronic	stressor,	potentially	resulting	in	multiple	negative	psychological,	behavioural,	and	physiological	consequences	for		 9	the	caregiver	(Bevans	&	Sternberg,	2012).		Frequently	defined	“as	the	strain	or	load	borne	by	a	person	who	cares	for	a	chronically	ill,	disabled,	or	elderly	family	member”,	caregiver	burden	often	coincides	with	other	stressors	(such	as	financial),	in	addition	to	uncertainty	around	the	VAD	patient’s	health	(Stucki	&	Mulvey,	2000,	quoted	in	Buhse,	2008).		However,	several	authors	point	to	the	positive	reflections	on	caregiving	many	of	their	study	participants	provide,	characterizing	caregiving	as	a	“longitudinal	process”	that	evolves	as	patients	and	caregivers	learn	to	incorporate	VAD	care	into	their	daily	lives	(Casida	et	al.,	2011;	Magid	et	al.,	2016;	Marcuccilli	&	Casida,	2011).		Still,	it	is	clear	that	an	opportunity	exists	to	support	caregivers	to	limit	the	impact	of	caregiver	burden	on	the	caregivers	and	those	being	cared	for.		Community	healthcare	providers.		While	patients	and	their	caregivers	are	expected	to	master	routine	VAD	care	themselves,	they	still	require	expert	guidance	on	issues	such	heart	failure	exacerbations,	anticoagulation	management,	and	emergency	care.		The	community	healthcare	providers	(cardiologists,	GPs)	they	may	consult	in	these	scenarios	often	have	little	or	no	knowledge	and	previous	experience	with	VADs	(Partyka	&	Taylor,	2014;	Wilson	et	al.,	2009).		Though	coordination	with	community	healthcare	providers	is	recommended,	there	is	no	standardized	approach	across	MCS	centre	programs	to	prepare	these	providers	for	patient	discharge	into	their	care	(Cook	et	al.,	2017;	Feldman	et	al.,	2013).			Emergency	healthcare	services.		Several	authors	highlight	the	particular	challenges	for	emergency	healthcare	providers	attempting	to	support	patients	with	a	VAD,	with	little	or	no	knowledge	of	the	device	(Partyka	&	Taylor,	2014;	Wilson	et	al.,	2009).		For	example,	given	the	non-pulsatile	flow	of	many	current	VAD	models,		 10	patients	may	have	no	palpable	pulses	(Cook	et	al.,	2017).		For	many	years,	guidelines	around	first-line	emergency	therapy	such	as	the	initiation	of	chest	compressions	for	cardiopulmonary	resuscitation	in	VAD	patients	have	not	existed	(Schweiger	et	al.,	2012).		The	American	Heart	Association	only	recently	released	guidelines	addressing	this	topic	directly	(Peberdy	et	al.,	2017).		Device	longevity	and	the	return	of	VAD	patients	to	their	home	communities	will	only	increase	the	likelihood	of	incidents	requiring	VAD	support	in	the	community.			Support	Approaches	To	address	the	challenges	of	VAD	care	in	the	community,	MCS	centres	have	developed	a	variety	of	approaches	to	support	VAD	patients	in	the	community	setting.			Many	MCS	centres	offer	direct	support	and	advice	to	patients	and	their	caregivers	through	remote	telephone	and	online	technologies	(Casida	&	Pastor,	2012;	Widmar	et	al.,	2014).		As	reported	by	one	centre,	VAD-expert	nurses	provide	24-hour	triage	support	through	a	“hotline”	to	resolve	patient	and	device	issues	remotely	(Kaan,	Kealy,	Andrews,	&	Gauthier,	2009).		Other	strategies	target	community	healthcare	providers	in	recognition	of	their	first-line	roles	in	supporting	VAD	patients	and	caregivers	where	they	live.		These	include	providing	training	in	basic	and	emergency	VAD	care	to	GPs,	hospital	staff,	and	the	emergency	services	(Casida	&	Pastor,	2012;	Widmar	et	al.,	2014).		Benefits	of	Community	Management	Estep	et	al.	(2015)	highlight	several	benefits	of	promoting	management	of	patients	by	healthcare	providers	(general	practitioners,	cardiologists,	nurse	practitioners)	in	the	community.		They	list	easier	follow-up	for	patients	and		 11	caregivers	(due	to	time	and	cost	saved	from	frequent	travel	to	the	MCS	centre)	which	may	result	in	improved	compliance	with	follow-up,	empowerment	of	community	care	provider	to	deliver	long-term	outpatient	care,	promoting	VAD-related	clinical	knowledge	and	skills	of	the	community	healthcare	provider	to	address	emergent	patient	issues,	all	while	promoting	care	within	the	established	relationship	of	the	patient	and	their	community	provider	(Estep	et	al.,	2015).		Moreover	the	cost	savings	outpatient	VAD	management	programs	offer	(over	in-patient	management)	is	substantial	(Morales	et	al.	2000).		Community	management	is	particularly	significant	for	Canadian	VAD	patients,	given	that	many	may	live	at	a	distance	from	MCS	centres,	as	centres	are	located	in	tertiary	care	hospitals	in	metropolitan	cities.			Rationale	The	nature,	utilization,	and	effectiveness	of	approaches	to	support	VAD	patients	in	the	community	remain	unclear,	as	few	studies	have	been	conducted	and	no	synthesis	of	approaches	currently	exists.		Therefore,	a	scoping	review	of	practices	is	an	appropriate	way	to	examine	and	map	the	range	of	approaches	available	to	support	patients	with	VADs,	their	caregivers,	and	their	healthcare	providers	in	the	community	setting	(Arksey	&	O’Malley,	2005).		Because	community	healthcare	providers	offer	vital	support	to	VAD	patients	and	caregivers	in	their	home	communities,	approaches	targeting	this	group	are	also	integral	to	this	review.		By	examining	the	characteristics,	contexts,	and	effectiveness	of	studied	approaches,	this	review	aims	to	consolidate	what	is	known	in	this	area	to	enhance	the	care	of	this	population	in	the	community.			 12	Research	Questions	The	questions	this	review	is	designed	to	address	are:		What	is	the	evidence	on	approaches	to	support	the	community	care	of	patients	implanted	with	Ventricular	Assist	Devices	(VAD)?			a. What	types	of	support	approaches	have	been	reported?	b. What	are	the	characteristics	and	contexts	of	these	support	approaches?	c. What	support	strategies	are	most	effective?	d. What	further	research	is	needed	to	establish	best	practice?			Conceptual	Framework	In	examining	efforts	to	promote	care	provision	in	the	community	for	VAD	patients,	this	review	is	guided	by	the	theory	of	self-care	of	chronic	illness.		Adapted	from	their	work	with	patients	with	heart	failure	to	the	management	of	chronic	illness	generally,	Reigel,	Jaarsma,	&	Strömberg	(2012)	define	self-care	as	“the	process	of	maintaining	health	through	health	promoting	practices	and	managing	illness”	(p.	195).		The	authors	argue	that	“for	those	who	seek	care	within	the	organized	health	system,	chronic	illness	impose[s]	a	set	of	behavioural	requirements”	(Riegel,	Jaarsma,	&	Stromberg,	2012).		It	is	clear	that	this	is	the	case	for	VAD	patients,	as	the	device	itself	requires	daily	maintenance	activities.			They	define	the	key	concepts	of	self-care	maintenance,	self-care	monitoring,	and	self-care	management	as	interrelated	processes.		Self-care	maintenance	includes	the	behaviours	performed	to	maintain	physical	stability	and	in	those	with	chronic	illness	often	include	the	recommendations	of	healthcare	providers	such	as	diet	or	medication	regimes	(Reigel,	Jaarsma,	&	Strömberg,	2012).		Self-care		 13	monitoring	includes	routine	body	“surveillance”	to	detect	when	a	change	has	occurred,	and	bridges	self-care	maintenance	to	management	(Reigel,	Jaarsma,	&	Strömberg,	2012).		Finally	self-care	management	includes	the	evaluation	of	detected	changes	to	determine	whether,	and	what	action	is	required	(Reigel,	Jaarsma,	&	Strömberg,	2012).		Kato,	Jaarsma,	&	Ben	Gal	(2014)	utilize	this	model	to	illustrate	the	self-care	requirements	of	VAD	patients	following	discharge.		These	processes	offer	several	clear	areas	of	focus	for	targeted	interventions	in	this	population,	and	will	be	used	to	guide	data	collection,	analysis,	and	abstraction	in	this	review.		Figure	1:	Model	of	the	theory	of	self-care	of	chronic	illness	adapted	for	VAD	patients		Adapted	from	“Learning	Self-care	After	Left	Ventricular	Assist	Device	Implantation”	by	N.	Kato,	T.	Jaarsma,	&	T.	Ben	Gal,	2014,	Curr	Heart	Failure	Report,	11,	p.	292.			Self-care	maintenance	• Care	of	LVAD	system		• Medication	adherence	• Adaptation	of	physical	activity		• Nutrition	and	diet	• Sleep	and	rest		Self-care	monitoring	• Device	• Driveline	site	• Vital	signs	• Symptoms	• Side	effects	Self-care	management	• Managing	alarms		• Responding	to	emergencies	• Contacting	the	MCS	team		• Modifying	medication,	rest,	and	diet			 14	Study	Significance	By	synthesizing	knowledge	from	current	studies,	the	findings	of	this	review	are	intended	to	identify	evidence-based	practices	to	support	VAD	patients	and	their	families	in	their	home	communities.		Its	dissemination	may	help	to	guide	nurses	and	other	clinicians	working	within	MCS	programs	to	utilize	evidence-based	approaches	to	support	their	patients	and	families.		This	review	also	offers	a	summary	of	potential	approaches	available	for	healthcare	providers	living	in	the	community,	to	support	VAD	patients	and	caregivers	in	their	care.		In	identifying	research	gaps,	it	is	also	intended	to	guide	ongoing	research	priorities	in	this	area.		Review	findings	may	also	help	inform	healthcare	policy	and	promote	funding	for	community	initiatives	in	VAD	care.				 15	Chapter	2:	Methods	Scoping	Review	A	scoping	review	is	a	growing	method	of	literature	review	used	to	clarify	the	range	and	nature	of	available	evidence	in	a	topic	area	(Polit	&	Beck,	2012).		Unlike	systematic	reviews	requiring	narrow	research	questions,	scoping	reviews	may	be	utilized	to	examine	and	“map”	broader	topic	areas	(Arksey	&	O’Malley,	2005).		As	Levac	et	al.	(2010)	point	out	they	are	particularly	suited	to	disciplines	where	evidence	is	still	emerging,	and	where	the	paucity	of	randomized	controlled	trials	makes	systematic	review	inappropriate.		Scoping	reviews	allow	for	synthesis	of	studies	with	diverse	methodologies	(including	published	and	grey	literature),	and	are	thus	suited	to	addressing	diverse	questions	(Levac	et	al.,	2010).		They	may	be	undertaken	as	a	preliminary	investigation	to	assess	the	range	and	nature	of	research	in	a	topic	area,	to	determine	the	feasibility	or	value	of	conducting	a	systematic	review,	as	a	standalone	project	to	summarize	and	disseminate	research	findings	to	stakeholders,	or	to	identify	gaps	in	the	research	(Arksey	&	O’Malley,	2005).			Since	a	preliminary	search	in	this	topic	area	revealed	too	few	sources	to	appropriately	undertake	formal	systematic	review,	scoping	review	was	chosen	for	its	stated	utility	and	flexibility	of	the	scoping	review	in	synthesizing	diverse	forms	of	research	evidence.		It	is	for	these	reasons	that	scoping	review	was	chosen	as	the	methodology	for	this	inquiry,	even	over	rapid	evidence	assessment,	as	the	latter	is	still	best	suited	to	address	relatively	narrow	questions	(Dijkers,	2015).		The	five-stage	scoping	review	framework	developed	by	Arksey	and	O’Malley	(2005),	with		 16	adaptations	by	Levac,	Colquhoun	&	O’Brien	(2010),	was	used	to	guide	the	methodology	of	this	review.				Stage	I:	Identifying	the	Research	Question		This	research	query	is	based	in	the	reviewer’s	clinical	experiences	in	an	MCS	centre	caring	for	and	preparing	adult	VAD	patients	and	their	families	for	discharge	from	hospital—many	of	whom	lived	several	hours	away.		The	construction	of	the	research	question	was	informed	by	discussions	with	the	committee	members	as	well	as	a	preliminary	probe	of	the	literature	identifying	a	gap	in	this	field.			Following	the	suggestion	by	Arksey	&	O’Malley	(2005),	special	consideration	was	made	as	to	which	aspects	were	most	important	to	the	study.		As	Levac	et	al.	(2010)	argue,	this	also	acts	as	the	foundation	of	an	effective	search	strategy.		It	was	the	intent	of	the	reviewer	to	capture	the	diversity	of	efforts	to	support	VAD	patients	and	their	families	in	the	community.		Thus	the	term	“approaches”	was	used	rather	than	“intervention”,	as	well	as	the	definition	of	“community	context”	as	all	environments	aside	from	the	MCS,	(though	approaches	may	still	be	delivered	from	the	MCS).		As	well	because	the	focus	of	this	question	was	to	capture	the	breadth	of	available	approaches,	the	search	was	expanded	to	include	paediatric	patients,	as	well	as	to	include	approaches	targeting	any	aspect	of	care	for	VAD	patients	occurring	outside	of	the	MCS	center.		Finally	community	healthcare	providers	were	themselves	conceptualized	as	supports	for	VAD	patients	and	families,	and	so	approaches	targeting	this	group	were	also	included.			The	follow-up	questions	were	developed	with	support	from	the	committee	members,	to	guide	the	focus	of	the	scoping	review.		A	research	proposal	to	guide	the		 17	scoping	review	was	developed	by	the	author	and	approved	by	the	committee	members.			Stage	II:	Identifying	Relevant	Studies	Bibliographic	databases	for	nursing	and	healthcare	related	research	were	searched,	including	CINAHL,	PubMed/MEDLINE,	and	the	Web	of	Science.		Search	terms	including	ventricular	assist	device,	community,	home	care,	ambulatory	care,	outpatient	management,	self-management,	self-care,	telehealth,	telemedicine,	telemonitoring,	and	peer	support	were	used	in	various	combinations	to	identify	articles	with	these	in	their	title,	abstract,	or	key	words.		Additional	searches	were	conducted	with	these	search	terms	using	Google	Scholar.			Given	the	overwhelming	number	of	results	returned	by	this	search	engine,	the	decision	was	made	to	limit	screening	to	the	first	100	citations	for	each	search.		These	search	results	were	also	carefully	screened	as	they	include	citations	from	diverse	sources	including	potentially	predatory	publications.		As	a	secondary	search	strategy,	the	reference	lists	of	included	studies	were	combed	for	applicable	studies.		References	were	managed	using	Mendeley	bibliographic	software.			Stage	III:	Study	Selection	Following	the	principles	of	the	scoping	review	methodology	developed	by	Arksey	&	O’Malley	(2005),	the	inclusion	and	exclusion	criteria	were	modified	iteratively.		To	capture	the	range	of	approaches	available	in	different	communities,	the	initial	criteria	for	inclusion	of	this	review	were	necessarily	broad.		The	emerging	nature	of	data	in	this	field	also	drove	broad	inclusion	criteria	to	ensure	an	adequate	aggregate	of	literature	to	conduct	the	review.		As	search	results	were	returned		 18	however,	and	given	that	a	single	reviewer	conducted	this	review,	the	scope	was	necessarily	limited	to	accommodate	this	as	well	as	the	limited	timeline	of	the	project.		Thus	the	post-hoc	decision	was	made	in	consultation	with	the	reviewer’s	project	committee	members	to	narrow	the	review	scope	to	research	studies,	though	regardless	of	methodology	(qualitative,	quantitative,	and	mixed	methods).		This	limitation	also	aligns	with	the	review	objective	of	identifying	the	research	evidence	on	these	approaches.			The	citation	titles	and	abstracts	were	screened	for	inclusion	against	the	eligibility	criteria.		If	eligibility	was	unclear	from	these,	the	study	was	included.		Full-text	analysis	was	then	performed,	allowing	for	a	secondary	screening	for	eligibility.			Inclusion	Criteria		Clients.	Studies	that	address	adult	or	paediatric	patients	with	VADs,	their	caregivers,	or	community	healthcare	providers	(such	as	cardiologists,	general	practitioners,	nurse	practitioners,	allied	health	or	emergency	services)	that	provide	care	to	patients	with	VADs.			Intervention.		Studies	of	existing	approaches	targeting	any	aspect	of	care	for	VAD	patients,	their	caregivers,	or	their	community	healthcare	providers.			Context.		A	key	definition	in	this	discussion	is	the	context	of	these	support	programs,	the	“community	setting”.		For	the	purposes	of	this	review,	it	is	defined	simply	as	all	settings	apart	from	the	MCS	centre,	in	which	a	VAD	patient	or	their	caregiver	may	access	VAD-related	care.		This	may	be	the	patient’s	home,	city	or	town,	or	even	their	community	hospital	(distinct	from	the	MCS	centre).		Therefore,	approaches	utilizing	online	or	telephone	technologies	delivered	from	the	MCS		 19	centre	were	included	given	that	patients	themselves	accessed	these	from	outside	of	the	MCS	centre.	Because	many	support	approaches	commence	at	the	MCS	centre	in	preparation	for	discharge,	a	distinction	was	made	between	studies	examining	in-hospital	discharge	practices	exclusively	and	those	including	discussion	of	community	preparation.		Again	because	the	latter	group	targets	care	occurring	in	the	community,	these	studies	were	included.				Source	studies.		Research	studies	of	all	methodologies	(including	systematic	reviews)	were	eligible	for	inclusion	in	the	form	of	original	articles.		Only	studies	with	full-text	English	versions	available	online	were	included.			Timeline.		To	account	for	the	evolution	of	MCS	programs,	this	review	included	studies	published	from	2000	to	2018.		This	period	incorporates	the	first	years	of	expansion	of	VAD	programs	to	the	outpatient	setting,	as	well	as	the	transition	from	pulsatile	to	continuous-flow	devices,	and	the	extension	of	device	use	in	Canada	and	internationally	as	destination	therapy	(Kirklin	et	al.,	2011).		Exclusion	Criteria	Clients.		Studies	including	patients	with	heart	failure	not	implanted	with	a	VAD,	or	patients	supported	by	other	forms	of	MCS	such	as	Total	Artifical	Heart	(TAH),	were	excluded	from	this	review.			Intervention.		Studies	that	describe	an	approach	with	potential	for	use	in	VAD	patients,	rather	than	an	established	approach,	were	excluded.		Source	studies.	Literature	including	commentaries,	literature	reviews,	editorials,	poster	presentations,	abstracts,	conference	proceedings,	narratives,		 20	books,	and	guidelines	were	excluded	from	this	review.		While	alternative	texts	such	as	descriptive	reports	were	initially	contemplated	for	inclusion	if	inadequate	research	studies	were	found,	they	were	eventually	excluded	given	the	volume	of	research	studies	identified.		Descriptive	reports	were	defined	as	articles	describing	approaches	or	technologies	but	failing	to	test	them	in	a	sample	population	(Hamine	et	al.,	2015).				Studies	returned	from	Google	Scholar	searches	were	carefully	scrutinized.		If	listed	articles	were	inaccessible	via	the	major	academic	databases	(CINAHL,	PubMEd,	and	Web	of	Science),	or	were	published	in	journals	included	on	known	predatory	publishing	journal	lists	such	as,	they	were	excluded.		Studies	not	published	in	English	or	inaccessible	online	were	also	excluded.		Stage	IV:	Charting	the	Data	Once	articles	were	chosen,	the	key	information	from	each	study	was	‘charted’	using	an	initial	data	extraction	table	developed	from	the	Joanna	Briggs	Institute	Methodology	for	JBI	Scoping	Reviews	template	(2015,	p.	14).		The	data	was	charted	onto	a	spreadsheet	using	Microsoft	Excel.		Columns	were	generated	to	include	general	bibliographic	information	(authors/year	of	publication/origin	country),	aims/purpose,	study	population/sample	size,	methodology/methods	(quantitative/qualitative/other),	intervention	characteristics	(type/comparator/	duration),	study	contexts,	outcomes	(quantitative	studies)	or	themes	(qualitative	studies),	key	findings	that	relate	to	the	review	questions,	and	the	results	of	critical	appraisal.		Following	the	process	as	identified	by	Arksey	&	O’Malley	(2005),	this	was		 21	again	an	iterative	exercise	as	further	columns	were	added	(such	as	device	type)	as	additional	variables	became	pertinent	and	as	the	reviewer	became	more	familiar	with	the	literature.		To	better	address	quality	assessment,	a	separate	data	extraction	table	was	created	to	encompass	methodological	concerns	including	strengths	and	weaknesses	of	studies.			A	separate	data	extraction	table	was	developed	to	address	the	original	review	questions,	including	columns	relating	to	the	type	of	support	approach	reported,	characteristics	and	contexts	of	these	support	approaches,	results	relating	to	intervention	effectiveness,	the	patient	or	caregiver	experience,	and	recommendations	for	further	research.		As	data	were	charted,	additional	columns	were	added	to	include	details	of	each	approach	including	examples,	and	clinical	or	health	outcomes	examined.				The	studies	were	then	charted	in	a	final	data	extraction	table	with	headings	corresponding	to	each	of	the	three	dimensions	from	the	theory	of	self-care	of	chronic	illness	including	self-care	maintenance,	self-care	monitoring,	and	self-care	management.		This	table	was	used	to	illustrate	whether	self-care	and	its	associated	dimensions	were	(or	were	not)	addressed	in	the	literature,	as	well	as	the	utility	of	this	theory	to	organize	data	on	approaches	used	in	this	field.		To	accommodate	approaches	that	may	not	fit	within	the	above	categories,	a	category	titled	additional	approaches	was	added.		These	charts	were	then	used	to	identify	patterns	in	the	community	support	approaches	used,	to	create	‘themes’.						 22	Stage	V:	Collating,	Summarizing,	and	Reporting	the	Results	This	stage	of	the	framework	involves	analyzing	the	data,	reporting	results,	and	interpreting	the	results	(Arksey	&	O’Malley,	2005).		“In	contrast	[to	systematic	reviews]	the	scoping	[review]	seeks	to	present	an	overview	of	all	the	material	reviewed”	(Arksey	&	O’Malley,	2005).		Arksey	&	O’Malley	(2005)	advise	presenting	this	in	two	ways.		First	is	by	providing	a	“basic	numerical	analysis	of	the	extent,	nature,	and	distribution	of	the	studies	included	in	the	review”	(Arksey	&	O’Malley,	2005).			Thus	the	characteristics	of	included	studies	were	broken	down	numerically	into	counts	and	percentages—stating	the	total	number	of	studies	included,	the	types	counts	and	proportion	of	different	study	designs,	the	years	of	publication,	types	of	interventions,	study	populations,	and	countries	where	studies	were	conducted	(Levac	et	al.,	2010).		Characteristics	such	as	years	of	publication,	study	distribution	geographically,	and	population	of	study	were	graphed	to	summarize	the	scope	of	research	activities	included	in	the	review.		As	the	second	method	to	summarize	and	report	the	review	results,	Arksey	&	O’Malley	(2005)	advise	organizing	and	analyzing	the	literature	“thematically”.		While	these	authors	indicate	that	reviewers	may	develop	their	own	framework	at	this	stage	(often	following	from	insights	developed	when	‘charting’	the	data),	the	authors	recognize	that	an	established	theoretical	framework	may	also	be	useful	to	guide	summarization	and	reporting	at	this	stage.		Levac	et	al.	(2010)	advise	that	at	this	stage	qualitative	content	analytical	techniques	may	be	useful,	and	that	qualitative	analytical	software	may	be	used	to	facilitate	this	process.			 23	As	previously	stated,	the	theory	of	self-care	of	chronic	illness	developed	by	Reigel,	Jaarsma,	&	Strömberg	(2012)	and	adapted	by	Kato,	Jaarsma,	&	Ben	Gal	(2014)	was	selected	at	the	study	outset	to	guide	review	analysis.		The	self-care	concepts	of	self-care	maintenance,	self-care	monitoring,	and	self-care	management,	were	used	as	themes	to	direct	content	analysis	of	the	study	data	initially.		Each	study	was	scrutinized	for	community	support	approaches	and	each	approach	was	analyzed	for	fit	within	one	of	these	three	categories.		If	the	described	approach	did	not	apply,	an	alternative	label	was	created.		These	alternative	labels	were	used	with	the	self-care	concepts	to	classify	identified	support	approaches	and	again	if	inappropriate,	another	new	label	was	applied.		Once	content	analysis	was	completed	with	each	study,	the	labels	were	re-examined,	compared	with	other	labels,	and	a	theme	applied	(Thomas	&	Harden,	2008).		Once	these	basic	themes	were	identified,	charts	were	generated	to	identify	the	studies	incorporating	these	themes.		These	charts	were	then	used	to	isolate	the	key	features	and	contexts	of	each	theme	and	the	approaches	they	included.		Another	chart	was	created	to	identify	the	studies	that	used	these	community	support	themes	to	address	the	three	self-care	processes.		Tables	were	also	created	to	identify	study	outcomes	and	quality	assessment	concerns.		These	results	were	then	presented	narratively.		This	final	synthesis	presents	a	summary	of	what	is	known	about	approaches	to	supporting	VAD	patients	and	their	families	in	their	home	communities.				 24	Quality	Assessment		While	the	original	scoping	review	protocol	by	Arksey	and	O’Malley	(2005)	specifically	excludes	a	quality	assessment	of	studies,	several	authors	note	the	limitations	of	evidence	for	practice	gleaned	from	poorly	conducted	studies	(Levac,	Colquhoun,	&	O’Brien,	2010,	Joanna	Briggs	Institute,	2015).		To	address	this	risk	without	sacrificing	the	comprehensiveness	of	this	review,	during	data	collection	each	study	was	critically	appraised	using	the	Joanna	Briggs	Institute	Critical	Appraisal	tools	for	use	in	JBI	Systematic	Reviews	(Aromataris,	&	Munn,	2017).		Critical	appraisal	focused	primarily	on	methodological	dimensions	such	as	validity,	rigour,	and	trustworthiness,	to	facilitate	assessment	of	the	evidence	(Polit	&	Beck,	2012).		The	quality	assessment	findings	were	included	in	the	data	extraction	table.		Studies	with	quality	concerns	were	included	for	analysis,	though	again	these	concerns	were	used	to	evaluate	the	body	of	evidence	in	the	synthesis	of	the	results	and	the	discussion	(Schneider,	Mohsenpour,	Joos,	&	Bozorgmehr,	2014).				 25	Chapter	3:	Results		 Following	scoping	review	protocol,	the	results	are	presented	first	by	a	descriptive	numerical	summary	of	the	17	included	studies,	followed	by	a	thematic	analysis	of	the	same	(Arksey	&	O’Malley,	2005;	Levac,	Colquhoun,	&	O	’Brien,	2010).		The	studies	are	then	broken	down	by	methodology	to	discuss	interventional	effectiveness	and	for	quality	assessment.			Search	and	Screening	Results	The	search	of	the	four	online	databases	yielded	1608	citations.		Title	and	abstracts	were	screened	initially,	and	duplicates	were	removed,	leaving	51	studies.		These	remaining	51	articles	were	obtained	for	full	text	review.		After	secondary	screening,	16	articles	were	selected	for	study	inclusion.		Source	type	was	a	common	reason	for	exclusion	at	this	stage—a	number	of	articles	excluded	were	descriptive	reports,	theoretical	papers,	and	abstracts.		Review	of	the	bibliographies	of	the	included	articles	yielded	an	additional	44	potential	articles	for	inclusion.		These	were	also	obtained	for	full-text	review,	but	many	only	addressed	hospital-based	outcomes	and	so	were	excluded.		One	additional	article	was	added	for	study	inclusion.		A	total	of	17	articles	were	included	for	this	scoping	review.		Figure	2	charts	the	detailed	outcomes	of	the	search,	screening,	and	exclusion	processes.								 26	Figure	2.	Flowchart	of	the	study	search	and	selection	process	 										Descriptive	and	Numerical	Summary		Of	the	17	studies	that	were	included,	eight	studies	were	from	the	United	States,	two	were	from	Australia,	two	were	from	Canada,	two	were	from	Germany,	two	were	from	Switzerland,	and	one	each	were	from	Austria,	Japan,	Sweden,	Turkey,	and	the	United	Kingdom.				Six	study	designs	were	utilized.		Eight	were	case	series,	three	were	quasi-experimental	studies,	two	were	qualitative	studies,	two	were	mixed-methods	studies,	one	was	an	outcome	evaluation	and	one	was	a	case	report	design.		Six	of	the	studies	were	published	2011	or	earlier,	while	the	majority	of	studies	were	published	within	the	last	five	years.					CINAHL,	PubMed,	Web	of	Science,	and	Google	Scholar	searched	1608	citations	returned	94	citations	screened	for	title	and	abstract	• 153	duplicates	removed	• 1514	abstracts	excluded	51	studies	obtained	for	full	text	review	• 35	studies	excluded	• 16	studies	selected	for	inclusion 		44	additional	citations	identified	• 43	studies	excluded	• 1	additional	study	selected	for	inclusion	17	studies	selected	for	inclusion		 27	Figure	3.		Study	distribution	by	country		Figure	4.		Study	distribution	by	year	of	publication		Study	sample	sizes	ranged	from	one	to	76,	included	data	from	one	to	nine	study	centres,	and	totalled	398	patients,	caregivers,	and	community	healthcare	providers.		The	majority	of	the	studies	targeted	VAD	patients	primarily,	though	four	studies	included	caregivers	along	with	VAD	patients	in	their	samples.		These	results	are	presented	graphically	in	Figures	3	and	4	and	detailed	in	Table	1.			0	1	2	3	4	5	6	7	8	9	0	1	2	3	4		28			Table	1.		Site	and	sample	features	of	the	17	studies	Study	Citation	Study	Centres	Sample	Size	Patients	Caregivers	Community	Care	Providers	Standing,	Exley,	MacGowan,	&	Rapley,	2017	1	31	20	11	0	Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017	1	22	0	9	13	MacIver	et	al.,	2009	1	24	24	0	0	Richenbacher	&	Seemuth,	2001		1	23*	14	626*	14	640*	0	0	Nomoto,	Utsumi,	&	Minakata,	2016	1	1	1	0	0	Schweiger	et	al.,	2015	9	12	12	0	0	Barber	&	Leslie,	2015	1	17	10	7	0	Biefer	et	al.,	2014	1	16	16	0	0	Slaughter,	Sobieski,	Martin,	Dia,	&	Silver,	2007	1	13	13	0	0	Morales,	Argenziano,	&	Oz,	2000	1	44	44	0	0	Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017	1	4	4	0	0	Pamboukian	et	al.,	2011	1	76	76	0	0	Iseler,	Fox,	&	Wierenga,	2018	1	10	10	0	0	Casida,	Aikens,	Craddock,	Aldrich,	&	Pagani,	2018	2	16	8	8	0	Bishop	et	al.,	2014	1	55	55	0	0	Pektok	et	al.,	2013	1	5	5	0	0	Drews	et	al.,	2003	1	38	38	0	0		*	In	this	study	by	Richenbacher	and	Seemuth	(2001),	data	from	an	additional	23	implanting	centres	were	used	for	comparison	to	“provide	a	more	realistic	estimate	of	the	hospital	discharge	rate	for	bridge	patients	receiving	VAD	support”	(p.	591).		 29	 	Review	Findings	Community	support	approaches.		To	address	the	initial	questions	of	this	review,	the	17	studies	were	analyzed	together.		The	reported	support	approaches	along	with	their	common	characteristics	and	contexts	were	identified,	grouped,	and	named.		Seven	themes	represent	the	approaches	extracted	from	the	17	included	studies.		Themes	representing	community	support	approaches	for	VAD	patients,	their	caregivers,	and	their	community	health	providers	include	MCS	team	support,	close	surveillance,	resource	provision,	community	provider	as	support,	provider	training,	peer	support,	and	educating	family	and	friends.		The	themes	are	presented	here	in	order	of	the	frequency	they	were	reported	in	the	studies.		Table	2	lists	the	reported	approaches	and	details	other	key	features.			MCS	team	support.		The	theme	MCS	team	support	incorporates	the	most	frequently	reported	community	support	approach.		These	approaches	were	reported	by	the	majority	of	studies	and	feature	strategies	centred	on	providing	VAD	patients	and	their	families	with	direct	communication	opportunities	with	clinicians	from	the	MCS	team.		A	commonly	used	approach	was	the	provision	of	hotlines	to	offer	24-hour	medical	and	technical	support	from	VAD	clinicians	(Biefer	et	al.,	2014;	Drews	et	al.,	2003;	MacIver	et	al.,	2009;	Morales,	Argenziano,	&	Oz,	2000;	Richenbacher	&	Seemuth,	2001),	or	regular	telephone	contact	initiated	by	the	VAD	team	as	a	prescribed	aspect	of	routine	outpatient	follow-up	(Iseler,	Fox,	&	Wierenga,	2018;	MacIver	et	al.,	2009;	Pamboukian	et	al.,	2011;	Richenbacher	&	Seemuth,	2001). 	 30	Table	2.		Frequency	of	support	approaches	reported	within	the	17	studies	Support Approach Number of Studies Approach User MCS Team Support  14  Telephone Communication  9 VAD patients and caregivers 24-hour hotline 5 VAD patients and caregivers Online communication  4 VAD patients and caregivers Prescribed regular communication 4 VAD patients and caregivers Novel technology  5 VAD patients and caregivers MCS team Coordination of community services 5 Primary care providers Emergency medical services Electrical company  Home visit 1 VAD patients and caregivers Close Surveillance 8  Mobile device application 2 VAD patients and caregivers VAD team Remote (invasive) monitoring technology 2 VAD patients and caregivers VAD team Home INR measurement 1 VAD patients and caregivers Prescribed regular communication 4 VAD patients and caregivers Discharge follow-up initiatives 2 VAD patients and caregivers Resource Provision 8  Letter explaining VAD 4 Primary care provider Emergency medical services Emergency department staff Electrical company List of emergency contacts 4 Emergency medical services Emergency department staff Emergency card with algorithm 1 Emergency medical services Emergency department staff Information booklet 2 VAD patients and caregivers Instructional video 1 VAD patients and caregivers  Community Provider as Support 8  General Practitioner  3 VAD patients and caregivers Home nurse  3 VAD patients and caregivers Specialized anticoagulation pharmacist 1 VAD patients and caregivers Emergency services 2 VAD patients and caregivers Received VAD training 4 VAD patients and caregivers Provider Training 4  Primary care provider 2 Primary care providers (general practitioners, pediatricians) Emergency medical services 2 Emergency medical services Cardiac rehabilitation services 1 Cardiac rehabilitation services Home health nurses 2 Home health nurses    Peer Support 3 VAD patients and caregivers Educating Family and Friends 2  Other family 2 VAD family members School staff 1 Other caregivers Classmates 1 Classmates 	 31	The	use	of	methods	to	promote	ease	and	regularity	of	contact	for	patients	with	the	MCS	team	was	the	stated	aim	of	several	approaches	(Casida,	Aikens,	Craddock,	Aldrich,	&	Pagani,	2018;	Nomoto,	Utsumi,	&	Minakata,	2016)	with	features	such	as	direct	access	to	MCS	clinicians	and	24-hour	availability	(Biefer	et	al.,	2014;	Drews	et	al.,	2003;	MacIver	et	al.,	2009;	Morales,	Argenziano,	&	Oz,	2000;	Richenbacher	&	Seemuth,	2001).		Specific	approaches	used	telephone	(Biefer	et	al.,	2014;	Drews	et	al.,	2003;	Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017;	Iseler,	Fox,	&	Wierenga,	2018;	MacIver	et	al.,	2009;	Morales,	Argenziano,	&	Oz,	2000;	Pamboukian	et	al.,	2011;	Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017;	Richenbacher	&	Seemuth,	2001),	cellular	text	(Nomoto,	Utsumi,	&	Minakata,	2016),	online	via	e-mail	(Pektok	et	al.,	2013),	or	via	technologies	such	as	video	conferencing	on	mobile	phone	applications	(Casida	et	al.,	2018)	or	remote	data	transmission	from	implanted	monitoring	devices	(Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017).		While	these	approaches	frequently	targeted	VAD	patients	and	caregivers	directly,	several	studies	reported	efforts	to	coordinate	care	between	the	MCS	centre	and	primary	healthcare	providers,	emergency	medical	services,	and	electrical	companies	that	provide	care	for	these	patients	in	the	community	(MacIver	et	al.,	2009;	Morales,	Argenziano,	&	Oz,	2000;	Richenbacher	&	Seemuth,	2001;	Schweiger	et	al.,	2015;	Slaughter	et	al.,	2007).		Several	of	these	highlighted	their	program’s	emergency	preparedness	efforts	such	as	notification	of	local	community	emergency	services	upon	patient	discharge	and	the	development	of	pre-emptive	emergency	transport	plans	(Morales,	Argenziano,	&	Oz,	2000;	Schweiger	et	al.,	2015;	Slaughter	et	al.,	2007).		 32	Close	surveillance.		Closely	related	to	MCS	team	support,	the	theme	of	close	surveillance,	refers	to	levels	of	patient	monitoring	by	the	VAD	team.		Though	patient-initiated	contact	of	the	MCS	team	was	encouraged	in	several	studies,	defining	each	of	these	approaches	is	the	responsibility	of	the	VAD	team	for	monitoring	and	responding	to	patient	data	(Casida	et	al.,	2018;	Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017;	Iseler,	Fox,	&	Wierenga,	2018;	MacIver	et	al.,	2009;	Nomoto,	Utsumi,	&	Minakata,	2016;	Pamboukian	et	al.,	2011;	Pektok	et	al.,	2013;	Richenbacher	&	Seemuth,	2001).		The	intensity	of	surveillance	including	frequency	of	patient	contact,	method	of	surveillance,	and	relative	burden	on	the	VAD	team	varied	considerably	between	approaches.		Several	studies	reported	prescribed	telephone	follow-up	calls	to	VAD	patients	at	predetermined	intervals	(often	daily,	weekly,	and	then	monthly)	following	discharge	(Iseler,	Fox,	&	Wierenga,	2018;	Pamboukian	et	al.,	2011).		Telephone	contact	was	an	aspect	of	usual	care	following	discharge	(MacIver	et	al.,	2009;	Richenbacher	&	Seemuth,	2001),	though	increased	contact	was	also	used	as	a	key	aspect	of	new	outpatient	management	interventions	(Iseler,	Fox,	&	Wierenga,	2018;	Pamboukian	et	al.,	2011).		Studies	also	reported	using	novel	technologies	to	monitor	VAD	patients	in	the	community.		These	included	VAD-specific	mobile	applications	(Casida	et	al.,	2018;	Nomoto,	Utsumi,	&	Minakata,	2016),	implanted	remote	monitoring	technologies	(Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017;	Pektok	et	al.,	2013),	and	a	point-of-care	INR	device	enabling	anticoagulation	measurement	at	home	(Bishop	et	al.,	2014).		The	mobile	applications	and	the	home	INR	device	require	VAD	patients		 33	to	program	their	daily	data	for	monitoring	by	the	VAD	team	(Bishop	et	al.,	2014;	Casida	et	al.,	2018;	Nomoto,	Utsumi,	&	Minakata,	2016).	Instead	of	patient’s	self	in-putting	data,	the	other	two	approaches	rely	on	implanted	monitoring	technology	to	transmit	patient	and	flow	data	(Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017;	Pektok	et	al.,	2013).		One	of	these	technologies	is	integrated	as	part	of	the	VAD	itself	(Pektok	et	al.,	2013)	whereas	the	other	is	a	sensor	requiring	implantation	alongside	VAD	implantation	(Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017).			Two	of	these	technologies	offer	automated	alerts	to	notify	the	VAD	team	in	case	of	abnormal	patient	data	or	when	an	alarm	is	triggered	(Casida	et	al.,	2018;	Hubbert,	Baranowski,	Delshad,	&	Ahn	2017).		The	other	three	technologies	require	the	daily	review	of	patient	data	by	a	VAD	team	member	or	a	specialized	anticoagulation	pharmacist	(Bishop	et	al.,	2014;	Nomoto,	Utsumi,	&	Minakata,	2016;	Pektok	et	al.	2013).		All	but	one	of	the	mobile	application	and	invasive	monitoring	technology	approaches	offered	real-time	data	transmission	capabilities	(instead	the	patient	was	required	to	transmit	stored	data	daily	through	connection	to	a	specialized	console)	(Pektok	et	al.	2013).			The	majority	of	these	studies	utilized	close	surveillance	approaches	to	pre-empt	or	address	outpatient	problems	and	promote	early	intervention.		Just	one	of	these	studies	utilized	close	surveillance	to	promote	the	development	of	a	more	holistic	self-care	skillset	by	initiating	an	individualized	patient	learning	plan	(Iseler,	Fox,	&	Wierenga,	2018).		Resource	provision.	This	was	characterized	by	approaches	including	providing	letters	explaining	the	VAD	system	and	common	aspects	of	VAD	care		 34	(MacIver	et	al.,	2009;	Morales,	Argenziano,	&	Oz,	2000;	Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017;	Slaughter	et	al.,	2007),	VAD	identification	cards	with	lists	of	emergency	contacts	(MacIver	et	al.,	2009;	Morales,	Argenziano,	&	Oz,	2000;	Schweiger	et	al.,	2015;	Slaughter	et	al.,	2007),	to	emergency	care	algorithms	(Schweiger	et	al.,	2015).		These	resources	were	primarily	targeted	to	community	health	providers	such	as	primary	healthcare	providers,	emergency	medical	services,	and	emergency	department	staff	to	help	them	to	navigate	the	care	of	VAD	patients	(including	prompt	involvement	of	the	VAD	team),	particularly	in	emergent	situations.			This	theme	was	also	used	to	support	the	education	of	VAD	patients	and	caregivers.		Educational	materials	in	the	form	of	information	booklets	on	driveline	care	(Barber	&	Leslie,	2015;	Biefer	et	al.,	2014),	and	instructional	videos	on	VAD	management	through	a	mobile	application	(Casida	et	al.,	2018)	were	offered.		Added	advantages	of	these	resources	were	their	easy	accessibility	(Barber	&	Leslie,	2015;	Biefer	et	al.,	2014),	role	in	promoting	consistency	in	teaching	of	the	VAD	care	as	well	as	providing	documentation	of	the	method	instructed	(Barber	&	Leslie,	2015).			Community	provider	as	support.		Community	provider	as	support	refers	to	VAD	programs	utilizing	community	healthcare	providers	to	deliver	both	VAD-specific	and	more	general	health	support	(such	as	bloodwork)	to	VAD	patients.		Instances	of	the	latter	were	included	in	this	theme	in	the	recognition	reported	in	many	studies	of	the	role	of	primary	care	physicians	and	home	health	nurses	in	providing	general	health	monitoring	and	support	for	VAD	patients.		Several	studies	reported	training	community	healthcare	providers	in	VAD	care	(Drews	et	al.,	2003;		 35	Iseler,	Fox,	&	Wierenga,	2018;	Morales,	Argenziano,	&	Oz,	2000;	Richenbacher	&	Seemuth,	2001;	Schweiger	et	al.,	2015),	though	only	two	of	these	reported	the	delegation	of	routine	VAD	care	to	the	primary	care	physician	because	of	the	distance	from	the	IC	(Morales,	Argenziano,	&	Oz,	2000),	and	in	cases	where	“no	family	member	could	be	trained”	to	provide	VAD	dressing	changes	(18,	p.	782).		Otherwise	even	when	community	healthcare	providers	were	involved	in	wound	management	and	dressing	care,	most	studies	indicated	that	VAD	patients	and	their	caregivers	remained	responsible	for	driveline	dressing	changes	and	other	aspects	of	routine	VAD	care	(Iseler,	Fox,	&	Wierenga,	2018;	Richenbacher	&	Seemuth,	2001).			Provider	training.		Provider	training	refers	to	the	provision	of	VAD	training	by	the	MCS	centre	to	community	healthcare	providers.		Often	coinciding	with	patient	discharge	into	the	community,	provider	training	provides	VAD	education	to	community	healthcare	providers	about	the	device	and	its	basic	functions.		This	includes	primary	healthcare	providers	such	as	general	practitioners	and	paediatricians	(Drews	et	al.,	2003;	Schweiger	et	al.,	2015),	emergency	medical	services	(Richenbacher	&	Seemuth,	2001;	Schweiger	et	al.,	2015),	home	health	nurses	(Iseler,	Fox,	&	Wierenga,	2018;	Richenbacher	&	Seemuth,	2001),	and	allied	health	services	such	as	those	involved	in	cardiac	rehabilitation	(Richenbacher	&	Seemuth,	2001).		Again	specific	mention	was	made	in	several	studies	of	the	importance	of	providing	VAD	training	to	emergency	medical	services	and	local	first	responders	(Richenbacher	&	Seemuth,	2001;	Schweiger	et	al.,	2015).		Researchers	cited	the	substantial	impact	emergency	healthcare	providers	have	on	patient	outcomes	in	cases	of	emergency	(Schweiger	et	al.,	2015).		Unfortunately	little	detail		 36	was	reported	on	the	methods	used	to	provide	provider	education.		One	study	(Richenbacher	&	Seemuth,	2001)	indicated	that	training	was	on-site,	while	in	another	study	though	researchers	advocated	for	hands-on	product	training	and	simulation	in	their	discussion	(Schweiger	et	al.,	2015),	they	failed	to	indicate	whether	these	methods	were	used	in	their	own	program.				Peer	support.		Peer	support	refers	to	the	assistance	VAD	patients	provide	to	each	other	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017;	Richenbacher	&	Seemuth,	2001;	Standing,	Exley,	MacGowan,	&	Rapley,	2017).		Peer	support	includes	the	provision	of	assistance	in	the	form	of	experiential	knowledge,	practical	advice,	and	psychosocial	support	around	coping	with	the	device	and	its	day-to-day	management	(Standing,	Exley,	MacGowan,	&	Rapley,	2017).		Sharing	experiential	knowledge	helped	VAD	patients	navigate	the	many	practical	challenges	of	living	with	a	VAD—and	offered	understanding	that	may	be	absent	from	other	relationships	(Standing,	Exley,	MacGowan,	&	Rapley,	2017).				While	these	communities	sometimes	developed	informally	through	contact	at	hospital	appointments	and	other	meet-ups	(Standing,	Exley,	MacGowan,	&	Rapley,	2017),	other	studies	reported	connecting	VAD	patients	to	each	other	more	explicitly	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017,	Richenbacher	&	Seemuth,	2001).		In	particular	these	studies	reported	connecting	more	experienced	VAD	patients	with	those	less	experienced	during	the	early	postimplanatation	period	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017)	or	upon	pending	discharge	from	the	hospital,	in	an	attempt	to	address	the	fears	and	concerns	new	VAD	patients	may	experience	(Richenbacher	&	Seemuth,	2001).		Peer	support	also	offered	notable		 37	benefits	to	the	VAD	patients	offering	support—	by	allowing	them	the	opportunity	to	help	others,	promoting	mutual	social	support	and	a	sense	of	camaraderie.		Peer	support	and	the	positive	social	and	developmental	impacts	of	connecting	paediatric	VAD	patients	to	each	other,	was	also	cited	in	the	paediatric	literature	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017).			Educating	family	and	friends.		In	contrast	to	provider	training,	this	theme	refers	to	the	provision	of	VAD	training	to	lay	people	within	the	VAD	patient’s	community.		This	was	an	approach	unique	to	the	paediatric	literature,	and	primarily	involved	the	provision	of	VAD	training	to	other	(non-parent)	caregivers	including	teachers,	other	school	staff,	and	extended	family	members	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017,	Schweiger	et	al.,	2015).		Ensuring	that	teachers	and	other	school	staff	were	VAD	trained	was	viewed	as	vital	to	ensuring	the	safe	reintegration	of	paediatric	VAD	patients	to	school.		One	study	reported	that	the	VAD	programs	surveyed	were	primarily	responsible	for	providing	this	education,	though	there	was	one	instance	reported	of	a	parent	educating	the	school	staff	themselves	(Schweiger	et	al.,	2015).		The	education	of	the	VAD	patient’s	peers	(classmates)	in	VAD	care	was	reported	by	several	centres	involved	in	this	same	study,	in	reported	efforts	to	“normalize”	the	device	and	the	patient	to	their	peers	(Schweiger	et	al.,	2015,	p.	459).				Conceptual	Framework	Theory	of	self-care	of	chronic	illness.		To	understand	how	the	extracted	support	approaches	promote	patient	self-care,	the	theory	of	self-care	of	chronic	Illness	was	used	to	analyze	the	extracted	support	approaches	according	to	the	self-	 38	care	process	they	address.		According	to	the	adaptation	of	the	theory	of	self-care	of	chronic	illness	for	VAD	patients,	self-care	maintenance	includes	the	behaviours	performed	to	maintain	physical	stability	including	the	routine	care	and	maintenance	of	the	device,	self-care	monitoring	includes	body	surveillance	to	detect	when	change	has	occurred	and	includes	VAD	parameters,	and	finally	self-care	management	includes	the	evaluation	of	detected	changes	to	determine	whether	and	what	action	may	be	required	(Kato,	Jaarsma,	&	Ben	Gal,	2014;	Riegel,	Jaarsma,	&	Strömberg,	2012).		To	better	appreciate	the	interaction	of	reported	approaches	with	the	processes	of	self-care	maintenance,	self-care	monitoring,	and	self-care	management,	the	results	were	compiled	in	Table	3.			Self-care	maintenance.		The	process	of	self-care	maintenance	was	the	target	of	community	support	approaches	in	four	studies	(Barber	&	Leslie,	2015;	Casida	et	al.,	2018;	Nomoto,	Utsumi,	&	Minakata,	2016;	Standing,	Exley,	MacGowan,	&	Rapley,	2017).		Resource	provision,	close	surveillance,	and	peer	support	were	used	to	promote	adherence	to	the	routine	activities	required	for	device	and	heart	failure	maintenance.		Close	surveillance	approaches	in	particular	sought	to	promote	maintenance	activities	by	providing	prompts	and	reminders	for	patients	to	complete	activities	such	as	dressing	changes	and	VAD	parameter	monitoring	(Casida	et	al.,	2018;	Nomoto,	Utsumi,	&	Minakata,	2016).		Other	approaches	included	the	development	of	an	informational	booklet	to	support	driveline	care	technique	in	the	community	(Barber	&	Leslie,	2015),	while	peer	support	was	an	often-informal	approach	based	in	the	community	developed	amongst	VAD	patients	and	sharing		 39	their	everyday	experiential	knowledge	around	life	with	their	devices	(Standing,	Exley,	MacGowan,	&	Rapley,	2017).			Table	3.		The	self-care	processes	of	chronic	illness	as	the	focus	of	reported	community	support	approaches	within	the	17	studies	Community	Support	Approach	 Self-Care	Maintenance	 Self-Care	Monitoring	 Self-Care	Management	MCS	Team	Support	 	 	 2,	3,	4,	5,	8,	11,	12,	14,	16,	17	Close	Surveillance		 5,	14	 5,	11,	14,	15	 5,	12,	14,	16	Resource	Provision	 7	 7	 6,	7,	9,	10		Community	Provider	as	Support		 	 	 	Provider	Training		 	 	 	Peer	Support		 1	 	 	Educating	Family	and	Friends			 	 	 		Study	Citation	1-	Standing,	Exley,	MacGowan,	&	Rapley,	2017	2-	Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017	3-	MacIver	et	al.,	2009	4-	Richenbacher	&	Seemuth,	2001	5-	Nomoto,	Utsumi,	&	Minakata,	2016	6-	Schweiger	et	al.,	2015	7-	Barber	&	Leslie,	2015	8-	Biefer	et	al.,	2014	9-	Slaughter,	Sobieski,	Martin,	Dia,	&	Silver,	2007	10-	Morales,	Argenziano,	&	Oz,	2000	11-	Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017	12-	Pamboukian	et	al.,	2011	13-	Iseler,	Fox,	&	Wierenga,	2018	14-	Casida,	Aikens,	Craddock,	Aldrich,	&	Pagani,	2018	15-	Bishop	et	al.,	2014	16-	Pektok	et	al.,	2013	17-	Drews	et	al.,	2003		Self-care	monitoring.		Support	approaches	targeted	the	process	of	self-care	monitoring	in	five	studies,	with	close	surveillance	the	most	frequently	associated	with	this	process.		Only	one	of	these	approaches	however	was	developed	explicitly	to	promote	patient	self-care	management	(Casida	et	al.,	2018).		The	others	were	developed	primarily	to	enhance	MCS	team	monitoring	of	VAD	patients	and	device		 40	parameters	through	technology	(Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017;	Pektok	et	al.,	2013a).		In	several	cases	the	technology	did	not	appear	to	notify	the	patient	directly	when	an	aberrant	value	or	alarm	was	triggered	and	instead	would	only	be	notified	when	the	MCS	team	member	followed	up	(Casida	et	al.,	2018;	Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017;	Pektok	et	al.,	2013).		These	instances	were	included	here	however	given	that	the	function	of	these	close	surveillance	technologies	was	still	dependent	on	participation	of	the	VAD	patient	(by	plugging	in	a	monitor	to	transmit	the	stored	values,	or	manually	in-putting	data),	and	that	this	participation	in	turn	promotes	the	development	of	the	“vigilant	body	monitoring”	or	“body	listening’”	competencies	of	the	self-care	monitoring	process	(Reigel,	Jaarsma,	&	Strömberg,	2012,	p.	196).		Development	of	these	competencies	was	also	encouraged	by	the	direction	from	the	MCS	team	that	patients	transmit	values	or	contact	the	MCS	team	directly	if	they	sensed	something	felt	“wrong	“(Hubbert,	Baranowski,	Delshad	&	Ahn,	2017,	p.e61).		Self-care	management.		The	process	of	self-care	management	was	the	focus	of	the	majority	of	reported	community	support	approaches.		In	many	of	these	studies,	self-care	management	occurred	via	regular	check-ins	initiated	by	the	MCS	team	(Iseler,	Fox,	&	Wierenga,	2018;	MacIver	et	al.,	2009;	Pamboukian	et	al.,	2011;	Richenbacher	&	Seemuth,	2001).		These	check-ins	help	to	promote	patient	self-care	management	by	encouraging	reflection	and	assisting	patients	to	interpret	the	meaning	of	their	signs	and	symptoms	to	identify	actual	or	potential	problems	(Pamboukian	et	al.,	2011).		By	offering	this	and	other	avenues	for	open	communication	(via	phone	call	or	using	text	or	e-mail),	these	support	approaches		 41	encourage	patients	to	seek	help	from	clinicians.		Timely	help	seeking	is	a	vital	aspect	of	the	self-care	management	process,	and	early	identification	of	patient	problems	was	the	stated	goal	of	several	approaches	(Nomoto,	Utsumi,	&	Minakata,	2016;	Pamboukian	et	al.,	2011).		Resource	provision	was	another	simple	way	many	programs	sought	to	support	self-care	management	in	the	community.		Providing	easy	access	to	contact	information	and	emergency	algorithms	(for	community	healthcare	providers)	was	intended	to	promote	early	involvement	of	the	MCS	team	when	required	(Biefer	et	al.,	2014;	Nomoto,	Utsumi,	&	Minakata,	2016,	Schweiger	et	al.,	2015;	Slaughter	et	al.,	2007).			Interventional	Effectiveness			To	evaluate	the	effectiveness	of	the	identified	support	strategies,	findings	from	the	17	studies	are	presented.		The	studies	are	discussed	according	to	methodological	approach	used	(qualitative,	quantitative,	or	mixed-methods)	to	facilitate	the	synthesis	of	the	diverse	forms	of	evidence	that	are	included	in	this	review.	Table	4	offers	a	breakdown	of	the	key	findings	of	each	study.			Qualitative	studies.		In	examining	the	communities	that	develop	among	VAD	patients,	Standing,	Exley,	MacGowan,	&	Rapley	(2018)	invoked	the	themes	of	“experiential	knowledge	and	understanding”	and	“social	comparisons”.		These	themes	refer	to	the	practical	knowledge	and	social	support	these	communities	offer,	and	their	role	in	promoting	patient	adaptation	to	live	with	their	devices.				42	Table	4.		Outcomes	and	key	findings	around	community	support	approaches	within	the	17	studies	Study	Citation	Outcomes	Key	Findings	Standing,	Exley,	MacGowan,	&	Rapley,	2017	• Themes	to	explore	the	experience	of	VAD	communities	and	their	influence	on	the	experience	of	living	with	the	device.	• Contact	with	other	VAD	patients	beneficial—help	accept	device	• Offer	social	support,	experiential	knowledge	absent	from	other	relationships	Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017	• Themes	to	"explore	the	perspectives	of	caregivers	of	school-aged	children	who	had	been	implanted	and	discharged	home	from	hospital	with	a	VAD".			• Key	themes:	being	physically	connected	to	a	device;	experiencing	changes;	living	a	medical	life;	negotiating	restrictions;	cost	of	care;	family,	kinship,	and	community;	present	and	future	living	MacIver	et	al.,	2009		• Duration	of	support	• Perioperative	mortality	• Adverse	events	(infection,	driveline	or	pocket	infection,	sepsis)	• 71%	met	discharge	criteria;	supported	in	the	community	for	3278	of	3647	days.			• Few	complications	in	the	community,	driveline	infection	the	most	common	complication--	75%	managed	with	a	single	course	of	antibiotics.			• Device	malfunction	2nd	most	common	but	identified	early.			Richenbacher	&	Seemuth,	2001		• Duration	of	support	(once	transplanted)	• Outpatient	support	duration	• Incidence	of	hospitalization	• Duration	of	unplanned	repeat	hospitalization	• Adverse	events	• Overall	reported	rate	of	discharge	is	artificially	low,	(previously	based	on	stringent	discharge	criteria	associated	with	device	trials)	• Posttrial	data	from	the	busier	heart	centres	in	the	US	indicate	discharge	rates	of	around	50%	(via	telephone	data).			Nomoto,	Utsumi,	&	Minakata,	2016		• Detection	of	adverse	events		• 2	instances	of	early	detection	(of	driveline	infection,	based	on	pictures	sent	by	patient)	-	MSSA	infection	and	abnormal	hemorrhage	Schweiger	et	al.,	2015		• Presence	of	right	heart	failure	• Duration	of	inpatient	and	outpatient	support	• Number	and	reason	for	readmission	• Number	of	adverse	events,	• Survival	to	transplantation.			• Successful	home	discharge	possible,	including	resumption	of	regular	activities	with	corresponding	improvement	in	psychosocial	experience	• Low	rate	of	adverse	events	and	complications	in	the	outpatient	setting--driveline	infection	the	most	common	complication.			Barber	&	Leslie,	2015	• Knowledge	of	driveline	infection	and	care	• Literature	review:	evolving	evidence	on		43		• Readability	of	booklet	driveline	infection	risk,	little	literature	detailing	teaching	methods	or	makeup	of	driveline	care	protocols/technique	or	adapted	for	home	environment.			• Survey:	participants	found	helpful	but	with	several	changes	advised	around	terminology,	formatting,	and	pictures	Biefer	et	al.,	2014		• Safety	of	the	outpatient	program	(not	defined	more	specifically).			• 1.6	calls	per	patient,	with	0.9	calls	per	100	patient	days.			• Many	calls	required	unplanned	clinic	visit	but	resolved	within	30	minutes.		• Several	emergency	calls	required	unplanned	hospitalization.			Slaughter	et	al.,	2007		• Discharge	outcomes:	time	on	VAD	support,	total	at-home	support,	average	alarms/day,	hospital	admission	for	malfunction.	• Patient	outcomes:	transplantation	or	explant,	return	to	activities	of	daily	living.	• Total	time	of	VAD	support	(75-324	days)	• Average	time	at	home	after	discharge	16	to	243	days	• Alarms	(average	6.7	a	day--majority	normal	battery	reminders)	or	inflow	cannula	occlusion	(majority	from	one	patient).		• No	patient	required	readmission	as	a	result	of	driver	malfunction.			Morales,	Argenziano,	&	Oz,	2000	• Days	of	outpatient	support	• Complications:	bleeding,	neurological	events,	infections	(device-related	and	non-device	related)	device	malfunctions	(minor	and	major),	and	unscheduled	hospitalizations.	• Outpatient	costs	and	quality	of	life	evaluated	informally	• 70%	of	patients	discharged	home	• Minimal	complication	incidence	• Successful	patient/caregiver	management	of	device	complications	• Improvements	in	QOL	and	inpatient	costs.			Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017	• Adverse	events	• Pressure	sensor	offers	feasible	and	accurate	monitoring	of	LAP	in	ambulatory	patients	at	home.			• Monitoring	provided	early	detection	of	pump	thrombosis	when	other	conventional	monitoring	did	not.			Pamboukian	et	al.,	2011	• 2-year	survival	• Intensive	surveillance	protocol	resulted	in		44		statistically	quantifiable	improvement	in	survival	for	patients	with	MCS	• Unexplained	by	device	type,	demographic	variable,	or	improvement	in	centre	experience	in	isolation.		Analysis	showed	robust	effect	of	protocol	on	survival.		Iseler,	Fox,	&	Wierenga,	2018		• 30-day	readmission	• Readmission	rate	of	6	patients	completing	the	program	was	14.3%	vs.	system	readmission	rate	of	32%.			• Of	the	4	participants	who	failed	to	complete	the	program,	30-day	hospital	readmission	was	44%.				Casida	et	al.,	2018		• Application	acceptability,	usability,	and	(patient)	competency	with	use.			• Promotion	of	early	detection	of	adverse	events.					• Feasible	to	use	an	app	to	assist	LVAD	patients	and	caregivers	to	assist	self-management	of	the	VAD	care	regimen.			Bishop	et	al.,	2014		• %	TTR	(Percent	of	time	in	therapeutic	INR	range),	incidence	of	major	bleeding,	incidence	of	thrombotic	events	• Patient	self-testing	of	INR	with	pharmacist	monitoring	associated	with	significantly	increased	percent	time	in	therapuetic	range	(%TTR)	than	usual	care.			• Less	major	bleeding	in	PST	than	UC	group	(not	significant)		• No	difference	in	thrombotic	events.			Pektok	et	al.,	2013		• Not	specified--alarms,	and	outcomes	from	alarms.			• Case	outcomes	and	alarms	discussed	anecdotally,	no	statistical	analysis	used.			• Benefits	of	remote	monitoring	still	theoretical			Drews	et	al.,	2003		• Incidence	of	VAD	complications	• Hospital	readmission	• Cause	of	death	• Infection	• Thromboembolic	or	bleeding	events		• Discharging	patients	home	did	not	increase	the	risk	of	complications,	including	systemic	infections	• Mortality	was	less	in	those	discharged	home	vs.	those	continuously	in	hospital			 45	In	their	exploration	of	the	experience	of	school-aged	VAD	patients	through	interviews	with	their	caregivers,	Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen	(2017)	presented	seven	themes	to	convey	these	experiences.		Among	them	“living	a	medical	life”	referred	to	the	role	of	constant	and	close	connection	with	the	MCS	team	and	other	health	professionals	as	a	significant	source	of	support	for	paediatric	VAD	patients	and	their	families.			Quantitative	studies.		Six	of	the	studies	were	descriptive	case	series	of	outpatient	management	programs	(Drews	et	al.,	2003;	MacIver	et	al.	2015;	Morales,	Argenziano,	&	Oz,	2000;	Richenbacher	&	Seemuth,	2001;	Schweiger	et	al.,	2015;	Slaughter	et	al.,	2007).		These	six	case	series	encompass	14	MCS	centres	and	the	145	VAD	patients	they	discharged	home.		They	found	relatively	low	levels	of	adverse	events	in	the	community	including	device	malfunction,	the	effective	patient	and	caregiver	management	of	device	alarms	and	events,	and	the	return	of	VAD	patients	to	many	pre-implantation	activities.		 	Basic	patient	outcomes	and	clinical	measures	were	used	(inpatient	length	of	stay,	duration	of	outpatient	support,	incidence	of	unplanned	readmission,	and	adverse	events)	to	provide	evidence	in	support	of	the	safety	of	managing	VAD	patients	in	their	communities.		Seven	intervention	studies	evaluated	novel	community	support	approaches	directly	(Biefer	et	al.,	2014;	Bishop	et	al.,	2014;	Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017;	Iseler,	Fox,	&	Wierenga,	2018;	Nomoto,	Utsumi,	&	Minakata,	2016;	Pamboukian	et	al.,	2011;	Pektok	et	al.,	2013).			Three	of	these	utilized	quasi-experimental	study	designs	(Bishop	et	al.,	2014;	Iseler,	Fox,	&	Wierenga,	2018;		 46	Pamboukian	et	al.,	2011).		Iseler,	Fox,	&	Wierenga	(2018)	instituted	a	pilot	transitional	care	management	program	to	decrease	30-day	readmission	rates,	reporting	a	25%	following	the	institution	of	their	program.		In	a	pilot	study	coupling	at-home	INR	monitoring	with	specialty	pharmacist-managed	anticoagulation,	Bishop	et	al.	(2014)	found	that	this	service	resulted	in	a	significantly	higher	percentage	of	time	in	target	INR	range	than	in	the	usual	care	group,	with	lower	incidence	of	major	bleeding	(though	this	was	not	statistically	significant)	without	a	difference	in	thrombotic	events.		Pamboukian	et	al.	(2011)	evaluated	the	initiation	of	an	intensive	surveillance	protocol	for	VAD	outpatients.		The	protocol	prescribes	weekly	phone	calls	along	with	predetermined	clinic	and	routine	testing	schedules,	to	identify,	triage,	and	promote	the	early	intervention	of	patient	problems.		The	authors	provide	robust	statistical	analyses	to	demonstrate	the	protocol’s	effect	on	improving	their	program’s	two-year	survival.	The	other	four	intervention	studies	were	small-scale	case	reports,	case	series,	and	an	outcome	evaluation.		Each	of	these	studies	cited	the	potential	of	the	support	approaches	they	explored	to	promote	early	recognition	of	patient	problems	in	the	community	and	thus	early	intervention.		Hubbert,	Baranowski,	Delshad,	&	Ahn	(2017)	reported	instances	of	early	detection	of	complications	including	pump	thrombosis	in	describing	the	use	of	an	implanted	pulmonary	pressure	monitoring	technology.		Nomoto,	Utsumi,	&	Minakata	(2016)	described	a	VAD-specific	mobile	application	and	presented	two	instances	of	early	detection	of	driveline	complications	as	a	result	of	its	use.		Pektok	et	al.	(2013)	described	a	remote	monitoring-enabled	VAD	and	provided	anecdotal	review	of	alarms	and	their		 47	management	in	the	evaluation	of	their	remote	monitoring-enabled	VAD.		Biefer	et	al.	(2014)	evaluated	the	outcomes	of	a	24-hour	hotline	providing	clinical	and	technical	support,	citing	the	number	of	unplanned	clinic	visits	(often	resulting	in	the	prompt	resolution	of	issues)	and	unplanned	hospitalizations	the	hotline	generated	to	indicate	the	need	for	the	service.		Mixed	methods	studies.		Two	studies	utilized	mixed	methods	approaches	to	describe	the	development	evaluation	of	their	interventions	(Barber	&	Leslie,	2015;	Casida,	Aikens,	Craddock,	Aldrich,	&	Pagani,	2017).		In	the	evaluation	of	their	patient	education	booklet	Barber	&	Leslie	(2015)	present	descriptive	statistics	and	content	analysis	to	analyze	the	survey	results.		Participants	agreed	the	booklet	was	a	useful	resource	to	support	driveline	care	at	home,	recommended	its	use	beginning	in	the	hospitalized	period,	and	advised	minor	modifications	to	promote	clarity.		Casida	et	al.	(2018)	surveyed	patients	and	conducted	semi-structured	interviews	to	obtain	a	comprehensive	evaluation	of	their	VAD	self-care	management	mobile	application.		Users	(a	combination	VAD	patients	and	their	caregivers)	rated	the	mobile	application	highly	in	acceptability,	usability,	and	competency,	describing	it	as	“very	helpful”	and	“very	reassuring”	(p.	163).		They	also	provided	several	suggestions	to	add	to	its	functionality	including	enhanced	data	management	and	trending	functions.			Quality	Assessment	While	quality	assessment	is	not	an	aspect	of	the	original	scoping	review	protocol	by	Arksey	and	O’Malley	(2005),	a	general	quality	appraisal	is	included	in	this	review	to	enhance	the	evaluation	of	evidence	in	this	area	(Levac,	Colquhoun,	&		 48	O	’Brien,	2010).		To	facilitate	this	appraisal,	the	studies	are	also	discussed	here	according	to	general	methodological	approach.		The	specifics	of	the	appraisal	for	each	study	are	detailed	in	Table	5.			49	Table	5.		Methodological	strengths	and	weaknesses	of	the	17	studies		Study	Citation	Study	Design	Strengths	Weaknesses	Standing,	Exley,	MacGowan,	&	Rapley,	2017	Qualitative—	phenomenology	• Typical	and	critical	case	sampling	• Discussion	of	themes	among	study	team	and	transcripts	with	peer	network	of	qualitative	researchers	• Confirmation	of	themes	with	gatekeeper	clinicians	and	subsequent	study	participants		• Inclusion	of	critical	cases	and	diverse/contrary	perspectives	• Single	centre	• Relatively	homogenous	sample	(included	members	of	a	close-knit	group)	• Research	orientation	of	researcher	not	discussed		Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017	 Qualitative—media	ecology	framework		• Snowball	sampling	• Diverse	carers	(parents,	teachers,	extended	family	members)	interviewed	to	facilitate	insights	from	the	different	environments	children	encounter	• Two	authors	independently	read	and	coded--discussion	and	comparison	informed	final	analysis	• Inclusion	of	large	number	of	de-identified	quotes	to	support	analysis	• Single	centre	• No	indication	of	the	number	of	different	children	'represented'	• No	use	of	other	data	to	triangulate	"media	ecology	approach"		MacIver	et	al.,	2009		Quantitative—case	series	• Discharge	criteria	and	process	described	in	detail	• No	inappropriate	causal	comparisons	(between	discharged	and	non-discharged	groups)	made		• Single	centre	• No	baseline	comparison	of	the	discharged	and	non-discharged	groups	directly	(only	discharged	vs.	total	cohort)	• No	comparison	to	pre-discharge	practices		Richenbacher	&	Seemuth,	2001	Quantitative—case	series	• Consecutive	patients	included	• Discharge	criteria	and	process	of	program	described	in	detail	• Data	from	peer-reviewed	clinical	series	included	in	analysis.			• While	only	for	comparison,	inclusion	of	data	provided	"by	telephone"	with	no	transparency	around	these	details--	threatens	confidence	in	study	assertion	of	higher	rates	of	discharge	than	currently	reported					50	Nomoto,	Utsumi,	&	Minakata,	2016	Quantitative—case	report	• Clear	and	detailed	description	of	the	intervention	(VAD	app)	components	and	functions	• Clear	description	of	the	intervention	procedures	• Discussion	around	potential	issues	around	remote	technologies		• Little	description	of	patient	demographics,	history	or	diagnostic	testing/assessment	methods		• Little	reporting	of	post-intervention	clinical	condition	Schweiger	et	al.,	2015		Quantitative—case	series		• Multi-centre,	international	study	• Clear	inclusion	criteria		• Detailed	reporting	of	patient	demographics	• Clear	and	detailed	reporting	of	clinical	information	at	implant	and	upon	discharge	• Study	outcomes	clearly	reported	• Appropriate	statistical	analysis			• Voluntary	study	inclusion—potential	for	bias	around	centres	with	more	successful	outcomes	• Reporting	sites	identified	but	not	detailed	Barber	&	Leslie,	2015		Mixed	methods—intervention	evaluation	• Literature	review	was	detailed	and	highlighted	gaps	in	literature	re:	wound	care	specifics	for	home	environment	or	teaching	specifics	• Survey	questions	were	provided	• Booklet	development	process	reported	in	full	• Validated	literacy	tools	were	used	• Single	centre	• Convenience	sampling	• Closed-ended	and	poorly	defined/worded	survey	questions			• Minimal	reporting	of	patient	demographics,	no	reporting	of	patient	clinical	profile	• Anecdotal	reporting	of	survey	results	(rather	than	quantitatively	or	with	theme	presentation	Biefer	et	al.,	2014		Quantitative—outcome	evaluation			• Clear	inclusion	criteria	and	justification	• Consecutive	inclusion	of	participants		• Clear	justification	for	incomplete	inclusion	of	calls	• Some	reporting	of	VAD	program.	• Single	centre	• Minimal	reporting	of	patient	demographics,	some	reporting	of	clinical	information	of	participants	• 	Use	of	non-validated	rating	scale	(but	used	in	a	previous	study),	some	reporting	of	study	program,	• Statistical	analysis	appears	inappropriate	at	times		Slaughter,	Sobieski,	Martin,	Dia,	&	Quantitative—• Criteria	for	inclusion	were	clear	• Use	of	standard	classifications	and	• Data	source	and	collection	procedures	not	specified			51	Silver,	2007		case	series	diagnostic	criteria	of	participants	• Consecutive	inclusion	of	participants	• Reporting	of	patient	demographics,	• Detailed	reporting	of	discharge	protocol/procedures	• Outcomes	poorly	defined	and	reported--QOL	results	reported	anecdotally	• Adverse	events	reported	anecdotally	• No	discussion	of	program/site	overall			Morales,	Argenziano,	&	Oz,	2000	Quantitative—case	series	• Consecutive	patients	included	• Inclusion	criteria	(discharge	home)	explicit	and	reasoned	• Clear	and	detailed	reporting	of	outcomes	and	follow-up	of	cases	• No	demographic	reporting	of	study	participants	or	those	excluded	from	study	• No	reporting	on	baseline	clinical	information	• Unclear	data	source	and	collection	procedures		Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017	Quantitative—case	series	• Standard,	reliable,	and	valid	methods	used	to	characterize	participant	clinical	profiles	and	demographics,	• Complete	inclusion	of	the	participants	• Clear	reporting	of	outcomes	of	the	cases	• Appropriate	statistical	analysis	• Unclear	how	clinical	condition	was	determined	• Eligibility	criteria	for	study	exclusion	not	stated		• No	statement	as	to	whether	participants	were	included	consecutively	• No	reporting	of	the	presenting	site	or	clinic	Pamboukian	et	al.,	2011		Quantitative--quasi-experimental;	one-group	pretest-posttest		• Large	sample	size	(n	=	76)	• Time	series	design		• Clear	temporal	relationship	between	the	variables	(2-year	survival)		• Participants	in	the	comparison	were	similar	(pre	and	post-intervention	were	compared	showing	non-significant	difference	statistically)	• Multiple	measure	of	the	outcome	both	pre	and	post	intervention	• Complete	follow-up	of	participants,	valid	and	reliable	• No	control	group	• Unclear	whether	sample	size	was	appropriate	to	ensure	meaningful	detectable	effects	of	potentially	confounding	factors			52	• Measurement	of	outcomes	in	all	participants	• Robust	and	comprehensive	statistical	analysis	to	examine	alternatives	Iseler,	Fox,	&	Wierenga,	2018		Quantitative—quasi-experimental;	one-group	pretest-post-test	design		• Clear	the	intervention	preceded	the	outcome	(effect)	• Clear	the	participants	were	receiving	similar	care	other	than	the	intervention	(continuing	with	regular	clinic	visits,	• Multiple	measurements	of	30-day	readmission	for	the	larger	cohort	in	year	prior	and	several	years	following,	• Participant	outcomes	measured	in	the	same	way	(30-day	readmission	rate)	• Poor	definition	of	intervention	components	and	model	• No	comparison	of	participants	to	control	group		• Clear	difference	between	the	group	that	completed	and	those	that	did	not	complete	the	program	(3	of	4	recruited	from	readmission	did	not	continue)-selection	bias	• Incomplete	follow-up	of	participants	but	little	discussion	and	no	analysis	of	patterns	re:	potential	differences	• Participant	outcomes	limited	to	30-day	readmission	rate	only,	simplistic	statistical	analysis--unclear	whether	decrease	in	rates	statistically	significant	Casida,	Aikens,	Craddock,	Aldrich,	&	Pagani,	2018	Mixed	methods—feasibility	study		• Congruence	between	the	research	question	and	mixed	methodology	• Sample	includes	both	patients	and	caregivers	• 	Congruence	between	the	research	methodology	and	data	collection	(survey	and	face	to	face	interviews)	• Intervention	development	(mobile	app)	based	on	self-management	theory	• Congruence	between	methodology	and	data	analysis	(Likert	scales	as	well	as	content	analysis	techniques),	• Appropriate	statistical	analysis,	• Representation	of	the	research	participant	voices	(including	caregivers	and	patients)			• Sample	size	criteria	not	determined	• Inclusion	criteria	may	limit	study	generalizability	(technology-literate,	relatively	well-educated	sample).				53	Bishop	et	al.,	2014		Quantitative—quasi-experimental;	non-equivalent	control	group	posttest	only	• Clear	cause	and	effect	in	the	study	• 	Detailed	reporting	of	intervention	and	comparison	group-similar,		• Groups	receiving	similar	treatments-management	by	two	cardiologists	and	clinical	VAD	care	(aside	from	the	exposure	of	interest),		• Control	group	used	for	comparison,	complete	follow-up	between	groups,	participant	outcomes	measured	similarly	(based	on	medical	record	and	INR	ranges),		• Outcomes	measured	in	reliable	way		• Appropriate	statistical	analysis		• No	comparison	of	baseline	(pre-intervention),		• Potentially	inadequate	followup	time	for	outcome	measurement	in	intervention	group	(author-identified)	as	only	3	participants	enrolled	in	PST	from	trial	beginning,		• Potentially	inadequate	sample	size	to	appreciate	different	effects	(since	effect	size	was	smaller	than	estimated)	Pektok	et	al.,	2013		Quantitative—case	series		• Inclusion	of	consecutive	participants,		• Inclusion	of	all	patients	were	included	in	the	report	• Patient	demographic	data	was	presented	• Unclear	how	clinical	condition	was	determined	• Inclusion	eligibility	unclear	• Reporting	of	clinical	information	was	generalized--while	NYHA	class	was	generalized	for	the	cases	overall	and	not	for	each	patient	• Discussion	of	alarms	was	only	anecdotal	• No	outcome	measures	were	identified	• No	statistical	analysis	was	completed.			Drews	et	al.,	2003		Quantitative—case	series	• Clear	inclusion	for	criteria	between	groups	• Consecutive	inclusion	of	cases	• Clear	reporting	of	demographics	and	clinical	information	of	participants	• Clear	reporting	of	outcomes	between	the	two	groups		• Clear	reporting	of	the	presenting	site	and	program	• Appropriate	statistical	analysis		• Unclear	how	clinical	condition	was	determined		• Unclear	whether	inclusion	of	participants	was	complete		• Temporal	component	may	confound	comparisons	as	many	patients	in	Group	B	were	implanted	early	in	the	VAD	program	(maturation	effect)		 54	Qualitative	studies.		The	studies	by	Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen	(2017)	and	Standing,	Exley,	MacGowan,	&	Rapley	(2018)	utilized	qualitative	methods	and	were	assessed	methodologically	using	the	Joanna	Briggs	Institute	Critical	Appraisal	tools	for	use	in	JBI	Systematic	Reviews	Checklist	for	Qualitative	Research	(Aromataris,	&	Munn,	2017).			Strengths	of	these	studies	included	their	use	of	rigorous	sampling	approaches	to	promote	study	depth	and	credibility	by	accessing	typical	and	critical	cases	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017;	Polit	&	Beck,	2012;	Standing,	Exley,	MacGowan,	&Rapley,	2018).		Other	efforts	to	enhance	the	trustworthiness	of	study	conclusions	included	detailed	discussion	of	transcripts	and	emerging	themes	amongst	the	researchers	to	discuss	themes,	exploration	of	the	emerging	themes	in	subsequent	interviews,	and	discussion	of	themes	with	VAD	clinicians	(Standing,	Exley,	MacGowan,	&	Rapley,	2017).		The	use	of	comprehensive	participant	quotes	corresponding	to	each	theme	in	both	studies	added	to	the	confirmability	and	credibility	of	the	research	findings	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017;	Polit	&	Beck,	2012;	Standing,	Exley,	MacGowan,	&	Rapley,	2017).			One	quality	concern	both	sets	of	authors	cited	in	their	studies	was	their	use	of	primarily	convenience	sampling	from	single	centres,	as	they	concede	this	may	limit	the	transferability	of	their	findings	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017;	Standing,	Exley,	MacGowan,	&	Rapley,	2017).			Quantitative	studies.		Thirteen	studies	employed	quantitative	methods	and	were	assessed	using	the	Joanna	Briggs	Institute	Critical	Appraisal	tools	for	use	in	JBI		 55	Systematic	Reviews	Checklist	for	Case	Series,	Case	Reports,	and	Quasi-Experimental	Studies	as	appropriate	(Aromataris,	&	Munn,	2017).			Strengths	of	the	quantitative	data	were	the	congruence	of	most	study	designs	to	their	research	questions,	with	studies	generally	adhering	to	the	assumptions	of	their	designs	(Lockwood	et	al.,	2017;	Moola	et	al.,	2017;	Tufanaru,	Munn,	Aromataris,	Campbell,	&	Hopp,	2017).	When	an	intervention	was	used,	details	of	the	intervention	were	usually	well	described	including	the	theory	informing	its		development	(Casida,	Aikens,	Craddock,	Aldrich,	&	Pagani,	2018;	Iseler,	Fox,	&	Wierenga,	2018).			A	weakness	of	the	quantitative	data	overall	was	the	proliferation	of	studies	from	single	centres,	involving	primarily	small	samples	sizes.		Several	oversights	threatened	the	internal	validity	of	the	quantitative	studies	included	(Polit	&	Beck,	2012).		When	quasi-experimental	design	was	used,	there	was	infrequent	discussion	of	power	analyses	to	determine	adequate	sample	size	(Polit	&	Beck,	2012).	Though	the	patient	demographics	were	usually	noted,	in	several	studies	this	was	only	anecdotally	described	(Morales,	Argenziano,	&	Oz,	2000;	Nomoto,	Utsumi,	&	Minakata,	2016;	Pektok	et	al.,	2013;	Slaughter,	Sobieski,	Martin,	Dia,	&	Silver,	2007).		When	the	patient	clinical	profile	was	discussed,	the	New	York	Heart	Association	classification	system	was	only	sometimes	used	and	the	heart	failure	aetiology	not	regularly	disclosed.		When	discussed,	data	collection	was	often	retrospectively	collected	from	the	medical	record.		While	reliable,	retrospective	collection	may	limit	the	available	data	for	analysis	(Polit	&	Beck,	2012).		Data	analysis	tended	to	utilize	simple	or	descriptive	statistics.		Overall	outcomes	were	both	poorly	defined	and		 56	reported.		Several	studies	provided	only	anecdotal	discussions	of	their	outcomes	(Morales,	Argenziano,	&	Oz,	2000;	Slaughter	et	al.,	2007).				 Mixed	methods	studies.		Two	studies,	one	by	Barber	&	Leslie	(2015)	and	the	other	by	Casida	et	al.	(2018)	employed	both	qualitative	and	quantitative	methods,	and	so	were	assessed	using	both	the	Joanna	Briggs	Institute	Critical	Appraisal	Tools	for	use	in	JBI	Systematic	Reviews	Checklist	for	Case	Series	and	Checklist	for	Qualitative	Research	(Aromataris,	&	Munn,	2017).				 Strengths	of	these	studies	were	the	congruence	between	the	study	question	and	the	mixed	method	design	used,	as	both	detailed	the	development	of	new	interventions	and	sought	both	quantitative	and	qualitative	feedback	on	the	user	experience.		Another	strength	was	their	explicit	use	of	literature	review	and	theory	to	inform	the	development	of	their	interventions.		The	development	processes	of	both	study	interventions	were	described	in	detail.		Both	studies	included	caregivers	as	well	as	patients	in	their	data	sampling,	in	recognition	that	both	are	potential	users	of	their	intervention.				 The	weaknesses	of	these	studies	varied.		The	Barber	&	Leslie	(2015)	study	utilized	a	single	convenience	sample,	provided	minimal	reporting	of	patient	demographics,	and	provided	primarily	anecdotal	reporting	(though	using	simple	statistics	and	patient	feedback)	of	survey	results.		The	inclusion	criteria	of	the	Casida	et	al.	(2018)	study	may	limit	the	external	validity	of	their	findings.				 57	Chapter	4:	Discussion	To	identify	the	evidence	on	approaches	to	support	the	community	care	of	patients	implanted	with	Ventricular	Assist	Devices,	this	section	returns	to	the	original	questions	of	this	review.		The	reported	community	support	approaches	are	identified,	their	key	characteristics	and	contexts	discussed,	and	the	effectiveness	of	the	approaches	assessed	according	to	evidence	presented	in	the	17	studies.		Recommendations	for	further	research	are	provided	in	the	following	section.			Reported	Approaches		The	seven	themes	of	MCS	team	support,	close	surveillance,	resource	provision,	community	provider	as	support,	provider	training,	peer	support,	and	educating	family	and	friends	encompass	the	community	support	approaches	reported	in	the	17	studies	included	in	this	scoping	review.		They	present	a	broad	range	of	both	contemporary	and	novel	pilot-tested	approaches	to	provide	support	to	VAD	patients	living	in	the	community.			These	themes	can	be	used	to	distil	the	core	elements	of	contemporary	MCS	outpatient	programs.		According	to	Table	2	of	Chapter	3,	support	approaches	around	MCS	team	support,	close	surveillance,	resource	provision,	and	community	provider	as	support	were	reported	in	close	to	half	of	the	reviewed	studies.		Most	studies	offered	24-hour	hotlines	to	connect	VAD	patients	to	the	MCS	team	directly,	prescribed	regular	telephone	check-ins	with	VAD	patients,	supplied	written	instructions	explaining	the	VAD,	and	utilized	community	general	practitioners	to	provide	ongoing	general	health	support.		Provider	training,	peer	support,	and	educating	family	and	friends	were	less	frequently	used	approaches.			 58	Approach	Characteristics	and	Contexts		The	makeup	of	each	theme	is	discussed	in	detail	in	the	Chapter	3.		The	key	features	common	to	the	approach	themes	are	discussed	here,	along	with	observed	trends.			MCS	centres	as	hubs	of	support.		The	number	of	studies	including	approaches	to	facilitate	MCS	team	support	makes	it	clear	that	MCS	centres	remain	the	hub	of	support	for	VAD	patients	even	when	they	return	to	their	home	communities.		Given	the	complexity	of	the	device,	its	specialized	management,	and	the	life-threatening	consequences	of	adverse	events	related	to	therapy,	I	argue	that	this	model	of	care	is	central	to	patient	safety	in	the	community.			Along	with	MCS	team	support,	the	approaches	incorporated	in	provider	training	and	close	surveillance	also	support	patient	safety	in	this	way.		Efforts	to	streamline	communication	between	VAD	patients,	their	community	healthcare	providers,	and	the	MCS	team	directly,	are	central	to	both	MCS	team	support	and	close	surveillance.		Telephone,	cellular	text,	e-mail,	mobile	videoconferencing	technology,	and	implanted	monitoring	devices	were	each	selected	to	promote	ease	of	contact	(Biefer	et	al.,	2014;	Casida,	Aikens,	Craddock,	Aldrich,	&	Pagani,	2017;	Hubbert,	Baranowski,	Delshad,	&	Ahn,	2017;	Nomoto,	Utsumi,	&	Minakata,	2016;	Pektok	et	al.,	2013).		Combined	with	24-hour	availability,	streamlined	contact	was	intended	promote	early,	shared	management	of	potential	patient	issues	with	the	MCS	team,	and	to	mobilize	treatment	in	cases	of	emergency	(Casida	et	al.,	2017;	Nomoto	et	al.,	2016).		The	role	of	MCS	clinicians	in	maintaining	the	close	surveillance	of	patients	in	the	community	also	reflects	this	model	of	care.		As	well	by		 59	ensuring	community	healthcare	providers	access	adequate	training,	provider	training	seeks	to	promote	the	management	of	basic	VAD	scenarios	and	the	recognition	of	emergencies	requiring	prompt	transfer	to	the	MCS	centre	(Richenbacher	&	Seemuth,	2001;	Schweiger	et	al.,	2015).				 Emergency	preparedness.		Citing	the	growing	proportion	of	community-living	VAD	patients	with	their	lengthening	time	on	support,	several	studies	anticipated	that	VAD	emergencies	will	increasingly	occur	in	the	community	(Richenbacher	&	Seemuth,	2001;	Schweiger	et	al.,	2015).		As	such	emergency	preparedness	was	factored	into	several	community	support	approach	themes,	and	was	a	defining	characteristic	of	approaches	targeting	community	healthcare	providers	specifically.		MCS	team	support	included	the	pre-emptive	coordination	of	emergency	transport	between	local	emergency	services	and	the	MCS	centre	while	resource	provision	frequently	targeted	emergency	healthcare	providers	through	the	provision	of	letters	explaining	the	VAD	system	and	common	aspects	of	care,	emergency	contact	lists,	identification	cards,	and	written	emergency	algorithms	(MacIver	et	al.,	2009;	Morales,	Argenziano,	&	C,	2000;	Schweiger	et	al.,	2015;	Slaughter,	Sobieski,	Martin,	Dia,	&	Silver,	2007).		Surprisingly	provider	training	was	a	little	used	approach	overall,	despite	its	potential	to	impact	emergency	preparedness.		This	may	be	because	of	its	resource-intensive	nature,	as	several	authors	recommend	hands-on	product	training	and	simulation	to	provide	effective	training	(Schweiger	et	al.,	2015).				 	Novel	technologies.		Although	approaches	utilizing	novel	technologies	may	revolutionize	the	way	support	for	VAD	patients	is	delivered	in	the	community,		 60	technology	development	appears	to	reflect	current	patterns	with	MCS	centres	remaining	the	hub	of	community	support.		Many	innovations	appear	focused	simply	on	enhancing	close	surveillance	capabilities	of	the	MCS	team	through	telemonitoring	(Hubbert	et	al.,	2017;	Pektok	et	al.,	2013;	Reiss	et	al.,	2018).		In	a	comprehensive	review	of	the	future	of	technology	in	VAD	care,	Saxon	(2016)	identifies	the	risk	of	data	overload	these	technologies	may	generate	for	clinicians,	arguing	instead	that	appropriate	data	management	is	the	key	to	translating	this	data	into	improvement	in	outcomes.		Moreover	regulatory	issues	around	remote	treatment,	data	security,	and	the	delegation	of	care	and	compensation,	remain	challenges	to	incorporating	these	technologies	into	routine	care	(Nomoto,	Utsimi,	&	Minakata,	2016;		Reiss	et	al.,	2018;	Saxon,	2016).			In	this	way,	the	study	by	Casida,	Aikens,	Craddock,	Aldrich,	&	Pagani	(2018),	stands	out.		They	developed	their	VAD	Care	mobile	application	to	address	the	complexity	of	VAD	self-care	management	by	making	key	self-care	management	processes	central	to	the	application’s	design	(Casida	et	al.,	2018).		While	they	used	an	alternative	theory	of	self-care	management,	the	conceptual	elements	they	used	to	inform	their	application’s	features	(self-efficacy,	goal	setting,	self-monitoring	and	reporting,	and	enlisting	coordinator	support),	parallel	the	theory	of	self-care	of	chronic	illness	concepts.		For	example,	automated	alerts	(“push	notifications”)	act	as	daily	reminders	to	complete	self-care	activities	and	promote	self-care	maintenance	competencies	while	potentially	replacing	the	frequent	phone	calls	made	by	VAD	coordinators	(Casida	et	al.,	2018,	p.	164).			 61	While	not	designed	to	specifically	address	clinician	workload,	promoting	the	development	of	patient	self-care	competencies	through	novel	technologies	in	this	way	offers	significant	benefits.		In	light	of	the	expansion	of	VAD	programs,	the	growing	community-living	population,	and	the	increasing	years	of	device	support,	the	responsibilities	of	VAD	coordinators	are	set	to	grow	tremendously	without	the	addition	of	further	data	surveillance	functions.		Initiatives	to	promote	positive	self-management	are	also	important	given	the	growing	data	on	self-efficacy	and	its	relationship	to	treatment	adherence	and	quality	of	life	in	this	population	(Casida	et	al.,	2018).			Approach	Effectiveness	Though	the	six	descriptive	case	series	of	outpatient	management	programs	reported	low	frequencies	of	adverse	events	and	improved	quality	of	life,	their	observational	designs	make	it	difficult	to	appraise	the	relative	effect	of	the	reported	support	approaches	(MCS	team	support,	community	provider	as	support,	resource	provision,	provider	training,	peer	support,	and	educating	family	and	friends)	on	these	clinical	outcomes	(Drews	et	al.,	2003;	MacIver	et	al.,	2009;	Morales	et	al.,	2000;	Richenbacher	&	Seemuth,	2001;	Schweiger	et	al.,	2015;	Slaughter	et	al.,	2007).		In	the	attempt	to	rank	the	effectiveness	of	the	reported	support	approaches,	this	discussion	attempts	to	isolate	the	evidence	on	singular	approaches	by	excluding	the	data	presented	by	these	six	studies.		 	Close	surveillance,	MCS	team	support.		Close	surveillance	and	MCS	team	support	appeared	to	be	the	most	effective	approaches	to	the	community	support	of	VAD	patients	currently	reported.		Research	evidence	to	support	the	use	of	close		 62	surveillance	is	varied	and	includes	the	case	series	data	on	outpatient	programs,	several	small-scale	intervention	studies	and	a	pair	of	quasi-experimental	studies.		The	most	promising	of	these	utilized	a	robust	study	design	and	a	sophisticated	statistical	analysis	to	highlight	the	role	of	close	surveillance	on	the	resulting	improvement	in	2-year	survival	within	their	program	(Pamboukian	et	al.,	2011).		Several	small-scale	intervention	studies	also	recommended	the	utility	of	the	close	surveillance	approaches	they	explored,	though	most	researchers	conceded	that	they	required	further	study	in	relation	to	patient,	clinical,	or	economic	outcomes	(Casida	et	al.,	2017;	Hubbert	et	al.,	2017;	Nomoto	et	al.,	2016;	Pektok	et	al.,	2013).	While	approaches	around	MCS	team	support	were	the	most	frequently	reported	in	the	literature,	much	of	the	evidence	cannot	be	isolated	from	the	outpatient	case	series	data.		Still,	the	outcome	evaluation	of	a	24-hour	VAD	hotline	(a	frequently	cited	approach	within	this	theme)	by	Biefer	et	al.	(2014)	provides	a	clear	endorsement	of	the	utility	of	this	common	approach	to	community	support.		While	they	received	a	relatively	low	frequency	of	calls,	the	authors	pointed	to	the	proportion	of	unplanned	clinic	visits	and	unplanned	hospitalizations	these	calls	generated	to	justify	the	provision	of	the	service.		Furthermore	the	qualitative	work	by	Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen	(2017)	highlights	the	‘lifeline’	these	approaches	provide	to	paediatric	VAD	patients	and	their	families.				 Resource	provision,	community	provider	as	support.		Resource	provision	and	community	provider	as	support	appear	to	be	secondary	approaches	to	community	support,	though	the	use	of	each	of	these	is	cited	in	close	to	half	of	the	17	studies.		In	addition	to	mentions	in	several	descriptive	case	series	of	outpatient		 63	management	programs,	two	approaches	to	resource	provision	were	evaluated	directly.		A	booklet	on	driveline	care	and	a	VAD-specific	mobile	application	were	both	evaluated	using	mixed	methods.		While	both	sets	of	authors	reported	that	their	resources	were	useful	to	the	sample	of	patients	studied,	they	were	not	evaluated	in	relation	to	impact	on	clinical	or	health	outcomes.		Aside	from	the	case	series	data,	only	the	study	by	Bishop	et	al.	(2014)	evaluated	the	role	of	community	healthcare	providers	in	providing	support	to	patients	in	the	community	(community	provider	as	support).		This	study	demonstrated	the	utility	of	specialty	pharmacists	in	managing	the	anticoagulation	of	VAD	patients	in	their	service.			Provider	training,	peer	support,	and	educating	family	and	friends.		While	they	are	certainly	cited	(primarily	in	the	case	series	data	on	outpatient	programs),	the	use	of	approaches	around	provider	training,	peer	support,	and	educating	family	and	friends	are	poorly	supported	in	the	literature.		None	of	the	studies	included	in	this	review	examined	these	support	approaches	directly.		While	provider	training	was	discussed	by	a	number	of	MCS	programs	in	the	case	series	data,	little	detail	was	provided	in	regard	to	its	implementation.		Aside	from	brief	mentions	in	two	other	studies,	the	evidence	of	peer	support	was	primarily	extrapolated	from	insights	on	the	role	of	VAD	communities	in	helping	patients	to	adapt	to	life	with	their	devices	(Standing,	Exley,	MacGowan,	&	Rapley,	2018).		Finally	while	approaches	around	educating	family	and	friends	were	described	as	vital	to	the	safe	integration	of	paediatric	VAD	patients	to	school,	its	examination	in	the	literature	remained	brief	(Schweiger	et	al.,	2015).			 64	Study	Limitations	As	with	many	review	initiatives,	this	study	is	subject	to	a	degree	of	publication	bias.		Ideally	search	strategies	are	exhaustive	and	may	include	hand-searching	journals,	reviewing	abstracts	from	conference	proceedings,	or	contacting	foundations,	to	limit	other	forms	of	systematic	bias	in	the	search	(Polit	&	Beck,	2012).		By	relying	only	on	published	reports	to	accommodate	the	timelines	of	this	project,	there	is	the	risk	that	this	review	underrepresents	studies	with	negative	findings,	which	may	impact	the	validity	of	this	review	(Polit	&	Beck,	2012).		Another	limitation	of	this	review	is	the	exclusion	of	abstracts	and	conference	proceedings.		After	initial	screening	it	became	clear	that	abstracts	represented	a	notable	proportion	of	research	activity	in	this	area,	but	because	their	short	form	inhibited	quality	appraisal,	they	were	determined	to	be	outside	of	the	scope	of	this	project.		Still,	they	provide	intriguing	evidence	of	the	additional	research	activities	in	this	area	and	their	exclusion	may	have	limited	the	comprehensiveness	of	this	review.			A	final	limitation	of	this	scoping	review	is	that	it	was	performed	by	a	single	reviewer.		Levac,	Colquhoun,	&	O’Brien	(2010)	recommend	that	a	team	of	researchers	meet	to	discuss	inclusion	decisions,	respond	to	ambiguity,	and	to	reach	consensus.		They	recommend	multiple-reviewer	consensus	to	promote	rigour	and	lend	confidence	in	the	validity	of	study	decisions.		While	two	committee	members	provided	advice	around	study	selection	and	research	methodology,	ultimately	decisions	around	study	inclusion	and	methodology	were	left	to	the	author.			 65	Chapter	5:	Conclusions	This	review	sought	to	examine	the	evidence	on	support	approaches	for	VAD	patients	living	in	the	community	through	a	scoping	review,	and	by	identifying	the	range	of	approaches	reported,	their	featured	characteristics	and	contexts,	and	identifying	which	of	these	strategies	appeared	to	be	most	effective.			The	seven	themes	distilled	from	the	17	studies	included	in	this	review	represent	a	range	of	differing	approaches.		These	include	approaches	around	MCS	team	support,	close	surveillance,	resource	provision,	community	provider	as	support,	provider	training,	peer	support,	and	educating	family	and	friends.		The	principles	of	MCS	centres	as	hubs	of	support,	emergency	preparedness,	and	novel	technologies	characterize	many	of	the	approaches	incorporated	by	these	themes.		Strategies	employing	close	surveillance	and	MCS	team	support	are	well	supported	in	the	literature,	while	the	use	of	resource	provision	and	community	provider	as	support	were	less	frequently	cited	and	evaluated	less	frequently.		Outside	of	brief	mentions	in	the	literature	the	utility	of	approaches	around	provider	training,	peer	support,	and	educating	family	and	friends	have	been	largely	unexamined.		Future	Research		To	address	the	final	question	of	this	review,	in	considering	what	further	research	is	needed	to	establish	best	practice,	I	offer	the	following	suggestions:			Study	design.		To	establish	best	practice,	researchers	in	this	area	must	seek	to	rigorously	evaluate	support	approaches.		Practically,	more	robust	study	designs	must	be	employed.		Because	blinding	is	impractical	for	many	interventional	studies	in	healthcare,	the	use	of	other	design	features	should	be	employed	to	enhance		 66	rigour	and	strengthen	the	inferences	made.		Pamboukian	et	al.	(2011)	utilized	several	such	features	including	time-series	design	as	well	as	sophisticated	statistical	analyses	to	exclude	the	influence	of	competing	factors.		Echoing	the	discussion	of	many	of	the	researchers	included	in	this	scoping	review,	support	approaches	require	evaluation	in	larger	and	more	diverse	samples.		To	augment	the	small	sample	sizes	of	many	current	studies,	multi-centre	studies	should	be	prioritized.		Alternatively	if	multi-centre	coordination	proves	difficult	to	achieve,	single	programs	may	seek	to	build	on	previous	work	by	replicating	previous	studies	within	their	setting.		Support	approaches	must	also	be	evaluated	in	terms	of	clearly	defined	and	rigorously	measured	outcomes,	including	patient	(quality	of	life),	clinical	(incidence	of	adverse	events),	and	economic	outcomes	(hospital	costs).		In	many	cases	study	outcomes	were	poorly	defined	and	only	anecdotally	described.		For	example	while	close	surveillance	technologies	may	be	easy	to	use	and	convenient,	their	influence	on	clinical	and	patient	outcomes	(by	promoting	early	detection	of	complications)	must	be	substantiated.		Economic	evaluation.		Economic	evaluations	of	community	support	approaches	might	also	be	considered	to	justify	their	use	in	the	current	healthcare	climate.		Many	studies	included	in	this	scoping	review	comment	on	the	need	to	justify	economically	the	use	of	these	(often	expensive)	technologies	and	support	by	illustrating	the	cost-savings	of	outpatient	programs	relative	to	inpatient	stays	(Nomoto,	Utsumi,	&	Minakata,	2016).		As	it	stands,	hospital	admission	following	device	implantation	tends	to	be	longer	and	more	costly	than	prior	to	implant,	with	similar	ongoing	outpatient	management	costs	(Baras	Shreibati,	Goldhaber-Fiebert,		 67	Banerjee,	Owens,	&	Hlatky,	2017).		These	authors	quantified	the	lifetime	cost	following	LVAD	implantation	over	the	cost	of	medical	management	as	an	additional	$364,400	incurred	(p.116).		While	a	number	of	similar	economic	evaluations	of	VAD	use	exist,	none	of	the	studies	examining	community	support	approaches	(including	in	the	search	stage	of	this	review)	included	economic	values	in	their	analysis.		Research	gaps.		While	the	evidence	around	the	effectiveness	of	many	community	support	approaches	remains	tenuous,	it	is	suggested	that	in	many	cases,	sufficient	evidence	exists	to	justify	their	more	careful	evaluation.		Though	the	results	of	this	review	indicate	the	limited	data	to	support	the	use	of	approaches	around	provider	training,	peer	support,	and	educating	family	and	friends,	their	cited	use	in	several	studies	calls	for	their	further	evaluation.		As	well	a	number	of	case	reports	and	case	series	included	in	this	study	may	provide	pilot	data	for	future	research.		Casida	et	al.	(2018)	disclose	that	the	results	of	their	feasibility	study	were	sufficient	to	obtain	funding	for	a	larger	trial.		Researchers	in	this	area	may	follow	this	example.	By	using	the	evidence	generated	by	similar	small	studies	(such	as	those	discussed	within	this	scoping	review)	to	seek	the	resources	to	facilitate	more	rigorous	evaluation	of	these	approaches,	researchers	may	build	on	the	intriguing	evidence	these	smaller	studies	offer.			Community	healthcare	providers.		The	results	of	this	scoping	review	indicated	a	paucity	of	research	projects	addressing	community	healthcare	providers	of	VAD	patients.		Despite	the	acknowledged	importance	of	emergency	care	on	health	outcomes	for	this	population,	emergency	and	community	healthcare	providers	were	addressed	only	as	recipients	of	resource	provision	or	provider	training	in	these	17		 68	studies	(MacIver	et	al.,	2009;	Morales,	Argenziano,	&	C,	2000;	Richenbacher	&	Seemuth,	2001;	Schweiger	et	al.,	2015;	Slaughter,	Sobieski,	Martin,	Dia,	&	Silver,	2007).		As	well,	the	studies	returned	in	the	initial	search	focusing	on	community	healthcare	providers	were	primarily	descriptive	reports	(and	so	were	excluded),	further	indicating	a	lack	of	research	evidence	on	approaches	addressing	this	population.		The	American	Heart	Association	did	release	guidelines	on	community	patient	care	and	cardiopulmonary	resuscitation	in	2017	to	address	this	deficit,	though	their	recommendations	appear	to	be	based	on	a	“consensus-derived”	review	of	the	literature	rather	than	a	strong	program	of	research	in	this	area	(Cook	et	al.,	2017;	Peberdy	et	al.,	2017).		Beyond	studies	evaluating	effectiveness,	qualitative	inquiries	are	required	to	better	understand	the	needs	of	emergency	and	community	healthcare	providers	in	caring	for	the	VAD	population.		Studies	sampling	emergency	medical	service	technicians,	community	general	practitioners,	and	emergency	department	staff	are	vital	to	representing	their	perspectives	and	identifying	their	needs	to	support	VAD	patients	in	the	community.			Peers	and	community	support.		Similarly,	only	two	studies	using	qualitative	methods	were	included	in	this	scoping	review	(Petruik,	Mack,	Conway,	Buchholz,	&	van	Manen,	2017;	Standing,	Exley,	MacGowan,	&	Rapley,	2017).		Still,	they	offered	important	insight	into	the	perspective	and	experiences	of	VAD	patients	and	families.		These	studies	help	to	contextualize	our	understanding	of	community	support	approaches	by	provide	rich	explorations	of	the	needs	and	experiences	of	this	specialized	population,	in	their	own	words.		As	in	the	study	on	the	experience	of	VAD	communities	where	the	theme	of	peer	support	was	extensively	explored,		 69	qualitative	studies	offer	insight	to	critically	inform	or	“validate”	the	provision	of	community	support.		Implications	for	Nursing	Practice.			In	combination	with	the	theory	of	self-care	of	chronic	illness,	nurses	can	use	any	of	the	seven	thematic	categories	of	approach	to	address	gaps	in	their	own	centre’s	provision	of	community	support.		By	analyzing	the	support	offered	by	their	program	according	to	the	self-care	processes	they	target,	nurses	can	identify	which	self-care	process	might	require	additional	interventions.		Table	3	in	Chapter	3	illustrates	the	approaches	most	frequently	associated	with	each	self-care	process.		Nurses	can	identify	the	approaches	commonly	associated	with	this	process	as	identified	in	the	literature,	and	select	an	appropriate	support	approach	or	combination	of	these.		For	example,	if	self-care	maintenance	was	a	neglected	process	in	the	community	support	approaches	offered,	an	evidence-based	approach	might	include	improving	the	written	resources	provided.		VAD	coordinators,	nurses	and	other	care	providers	in	MCS	programs	(such	as	perfusionists)	are	well	positioned	to	develop	additional	approaches	to	address	the	needs	of	VAD	patients	and	their	families.		For	these	clinicians,	the	themes	(and	their	key	features)	identified	in	this	scoping	review	provide	a	guide	for	the	development	of	new	approaches	to	address	the	self-care	processes.		Using	the	above	example,	to	address	the	process	of	self-care	maintenance,	nurses	within	MCS	centres	may	produce	instructional	videos	to	augment	their	written	resource	provision,	or	promote	peer	support	by	coordinating	a	buddy	system	connecting	new	and	experienced	VAD	patients.			 70	Nursing	Research			In	this	way,	these	themes	may	also	provide	nurse	researchers	with	a	number	of	potential	study	foci,	by	highlighting	the	potential	utility	of	an	established	approach	or	stimulating	the	development	of	a	novel	strategy.		Furthermore,	by	identifying	explicit	gaps	in	knowledge	in	this	area,	this	scoping	review	will	help	inform	future	research	in	this	area.		Finally,	this	study	illustrates	the	utility	of	scoping	review	methodology	for	addressing	the	diverse	queries	of	nursing	practice.		The	flexibility	of	this	approach	suited	the	questions,	scale,	and	diversity	of	study	methodologies	characteristic	of	this	developing	area	of	study.		Knowledge	Translation	The	optional	final	stage	of	the	Arksey	&	O’Malley	(2005)	scoping	review	protocol	is	the	consultation	with	content	experts	and	stakeholders	in	the	field.		Though	beyond	the	scope	of	this	project,	consultation	offers	both	the	opportunity	to	enhance	study	validity	by	helping	to	confirm	study	results,	and	the	opportunity	to	promote	knowledge	translation	by	disseminating	findings	to	clinical	stakeholders	directly	(Arksey	&	O’Malley,	2005;	Levac,	Colquhoun,	&	O	’brien,	2010).		Alternatively,	other	efforts	to	disseminate	scoping	review	findings	must	target	community	healthcare	providers	as	well	as	clinicians	within	MCS	programs.		As	many	of	the	review	studies	noted,	these	providers	will	care	for	VAD	patients	for	a	growing	proportion	of	their	support	time	(as	the	bulk	of	this	is	now	spent	in	the	community),	and	education	of	these	providers	must	be	a	priority.		Facilitating	knowledge	of	potential	approaches	to	support	community	healthcare	providers	to		 71	in	turn	support	VAD	patients	in	their	care,	is	the	intent	of	this	scoping	review.		Thus	research	publications	in	professional	journals	catering	to	emergency	health	service	providers	and	primary	care	providers	must	be	targeted	along	with	traditional	MCS	and	transplant-focused	publications.			Summary	This	scoping	review	provides	a	novel	synthesis	of	evidence	of	approaches	to	support	VAD	patients	and	their	caregivers	living	in	the	community.		By	selecting	only	research	studies,	identifying	the	support	approaches	they	report	and	the	contexts	and	key	features	of	their	use	it	offers	a	comprehensive	assessment	of	the	research	evidence	in	this	growing	field.		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