STUDY PROTOCOL Open AccessPost-discharge management following hipfracture - get you back to B4: A parallel group,randomized controlled trial study protocolWendy L Cook1,2,3,4, Karim M Khan1,2,5,6, Michelle H Bech4, Penelope M Brasher2,7, Roy A Brown4, Stirling Bryan2,7,8,Meghan G Donaldson1,2, Pierre Guy1,2,9, Heather M Hanson1,2,5, Cheryl Leia2,10, Erin M Macri1,2,5,Joanie Sims-Gould1,2,5, Heather A McKay1,2,5,9 and Maureen C Ashe1,2,5*AbstractBackground: Fall-related hip fractures result in significant personal and societal consequences; importantly, up tohalf of older adults with hip fracture never regain their previous level of mobility. Strategies of follow-up care forolder adults after fracture have improved investigation for osteoporosis; but managing bone health alone is notenough. Prevention of fractures requires management of both bone health and falls risk factors (including thecontributing role of cognition, balance and continence) to improve outcomes.Methods/Design: This is a parallel group, pragmatic randomized controlled trial to test the effectiveness of a post-fracture clinic compared with usual care on mobility for older adults following their hospitalization for hip fracture.Participants randomized to the intervention will attend a fracture follow-up clinic where a geriatrician andphysiotherapist will assess and manage their mobility and other health issues. Depending on needs identified atthe clinical assessment, participants may receive individualized and group-based outpatient physiotherapy, and ahome exercise program. Our primary objective is to assess the effectiveness of a novel post-discharge fracturemanagement strategy on the mobility of older adults after hip fracture.We will enrol 130 older adults (65 years+) who have sustained a hip fracture in the previous three months, andwere admitted to hospital from home and are expected to be discharged home. We will exclude older adults whoprior to the fracture were: unable to walk 10 meters; diagnosed with dementia and/or significant comorbiditiesthat would preclude their participation in the clinical service.Eligible participants will be randomly assigned to the Intervention or Usual Care groups by remote allocation. Treatmentallocation will be concealed; investigators, measurement team and primary data analysts will be blinded to group allocation.Our primary outcome is mobility, operationalized as the Short Physical Performance Battery at 12 months. Secondaryoutcomes include frailty, rehospitalizations, falls risk factors, quality of life, as well as physical activity and sedentarybehaviour. We will conduct an economic evaluation to determine health related costs in the first year, and a processevaluation to ascertain the acceptance of the program by older adults, as well as clinicians and staff within the clinic.Trial registration number: ClinicalTrials.gov: NCT01254942BackgroundHip fractures are serious, life-limiting and costly eventsfor older adults. Each year in Canada there are over27,000 hip fractures [1], and older adults who sustain alow-trauma hip fracture have higher risk of death anddisability. In the first year after the fracture, as many as20% of people die [2]; and up to half of seniors will notregain their pre-fracture level of mobility [3,4] leavingthem at risk for further falls [5] and fracture injuries[6-9]. Therefore, despite advances in surgical and medi-cal management following hip fracture, up to half of hipfracture patients do not regain their independence orreturn to prefracture functional mobility.* Correspondence: Maureen.Ashe@exchange.ubc.ca1Centre for Hip Health and Mobility, Vancouver, CanadaFull list of author information is available at the end of the articleCook et al. BMC Geriatrics 2011, 11:30http://www.biomedcentral.com/1471-2318/11/30© 2011 Cook et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.After hip fracture, systematic structured follow-upstrategies for older adults [10,11] improve investigationrates for osteoporosis; and fracture liaison services[10-23] after fracture are beneficial. Many previousinterventions, however, have focused on bone healthmanagement, and to our knowledge only a few studies[18,20] have included patient referral for falls riskassessment. Osteoporosis care can be improved, but asfractures occur because of low bone mass and falls, it isimportant to also address falls risk [24]. It is noteworthythat despite being prescribed osteoporosis medication[11] some patients who attended a fracture liaison ser-vice had a subsequent fall-related low trauma fracture.Hence, the need to coordinate both falls prevention andbone health initiatives [11].Ferrucci and colleagues [25] discuss that hip fracturecan result in “catastrophic disability” for older adultsdue to the unanticipated deterioration in functionalability [25] in some activities of daily living and mobi-lity. Decreased mobility, in turn, impacts on the riskfor future injury. Importantly, older adults who sustainhip fracture are at an increased risk of future hip frac-ture [26,27]. A systematic review [8] emphasized thatprevious falls [28], low bone density [28,29], and mobi-lity impairment [28] are major risk factors for secondhip fracture. Approximately 90% of fractures occur asa result of a fall [30] and after hip fracture, up to halfof people can fall again within the first 6 months fol-lowing fracture [5,31]. These data emphasise theimportance of a two-pronged approach to reducing hipfractures - addressing falls risk as well as low bonemass [32].Compelling evidence supports the recommendationfor strength and balance exercises for falls risk reductionin vulnerable populations [33-36]. Exercise improveslower limb muscle strength and it can maintain bonemass in post-menopausal women [37-39]. A Cochranesystematic review [40] reported six trials that evaluatedexercise interventions for people after hospital dischargefollowing hip fracture. Balance and strength measuresimproved overall; in particular, Binder and colleagues[41] reported a significant improvement in mobilitymeasures after a six month out-patient physical therapyintervention.Therefore, the purpose of the current study is to eval-uate the clinical and cost effectiveness of a novel post-discharge fracture management strategy for community-dwelling older adults after hip fracture. It is anticipatedthat initiating an individualized outpatient managementprogram after hospital discharge, which includes fallsand fracture risk assessment and management, and anindividualized exercise program under the ongoing gui-dance of a physical therapist, will improve mobility, andreduce disability and falls.Methods/designStudy AimsThe primary aim of this study is to assess the effective-ness of a comprehensive post-fracture clinic withextended rehabilitation for community-dwelling olderadults following hip fracture on mobility. Secondaryaims include prospectively (i) determining costs asso-ciated with hip fracture, and our intervention, and (ii)completing a process evaluation as part of our inte-grated knowledge translation plan.Study Design and SettingWe propose a parallel group, pragmatic [42] single blindrandomized controlled trial of two different deliverymodes of post hip fracture management- Usual Carealone versus Usual Care plus specialized outpatient frac-ture follow-up management. This study will take placeat two academic teaching hospitals in Vancouver,Canada. Vancouver is the largest city in the province ofBritish Columbia and with an estimated population of578,000 and 13% of the population are adults aged 65years+ (2006 Census Data; http://vancouver.ca/commsvcs/planning/census/2006/index.htm). Our clinicis located within the Vancouver Coastal Health Author-ity (VCHA) catchment area.Ethical ApprovalWe have obtained ethical approval from the Universityof British Columbia (UBC) Clinical Research EthicsBoard, Vancouver Coastal Health Research InstituteEthics Board, and Providence Health Ethics Board. Allparticipants will provide written informed consent priorto participating in the study (Clinical Trials RegistrationNCT01254942).ParticipantsWe will include 130 community-dwelling older adults(women and men) aged 65 years+ who, with a recenthistory (within past 3 months) of hip fracture, wereadmitted to hospital from home and expected to be dis-charged home. We will exclude older adults who priorto the fracture were: unable to walk 10 meters; diag-nosed with dementia; and/or with significant comorbid-ities that would preclude their participation in theclinical service.Identification of Eligible ParticipantsOur recruitment coordinator will identify and enrolpatients into the study prior to discharge from hospi-tal, rehabilitation unit and/or from a discharge list ofeligible older adults. Identification of potential partici-pants will be facilitated by the clinical staff; in addi-tion, recruitment posters will also be placed on theward and on the Centre for Hip Health and Mobilitywebsite. The recruitment coordinator will providewritten and verbal information to all eligibleparticipants.Cook et al. BMC Geriatrics 2011, 11:30http://www.biomedcentral.com/1471-2318/11/30Page 2 of 7RandomizationTreatment allocation will be concealed; a statisticianindependent of the study will generate the allocationsequence using randomized blocks of varying size; wewill stratify randomization by hospital site and sex. Thislist will be provided to a centralized, web-based rando-mization service. At the completion of the baselineassessment the study coordinator will use the online ser-vice to determine the next allocation. Investigators, themeasurement team and data analysts will be blinded togroup assignment throughout the trial (Flow Diagram inFigure 1).Study InterventionsUsual Care (UC) group Participants who are rando-mized to the UC Group will receive usual orthopaedicand rehabilitation post-operative treatment for the hipfracture. Participants in the UC Group will be offeredthe Fracture Follow-up Clinic at 12 months (please seebelow for description).Intervention (B4) group Participants who are rando-mized to this group will attend an enhanced post-frac-ture follow-up clinic for outpatient management of fallsand fracture risk. The clinic has been designed based onthe need to assess both falls risk factors and bonehealth. A geriatrician will lead the clinic and will providepost-fracture assessment and management. The clinicalassessment will focus on four key areas to address sec-ondary prevention of future injury by addressing keydomains that contribute to fall and fracture risk, andinclude assessment of: balance, bone health, brain func-tion and bladder function = B4 Clinic. Based on identi-fied need during the geriatric assessment, participantsmay also be referred to additional health professionalssuch as occupational therapist, registered dietician,social worker etc.In addition, while at the clinic, participants will also beassessed by a physiotherapist who will recommend anexercise program and, may recommend subsequentonsite outpatient physiotherapy visits. Participants willalso receive a standardized home exercise program. Fol-lowing discharge from outpatient physiotherapy, partici-pants will also receive up to four additional telephonecalls based on motivational interviewing [43], and wewill use techniques to problem solve and facilitate goalsetting around mobility and regular engagement in phy-sical activity. If during these sessions, the participantidentifies a mobility concern, she/he will be encouragedto follow-up with the B4 Clinic.OutcomesData Collection ProtocolMeasurements will be conducted at the Centre for HipHealth and Mobility, Vancouver Coastal Heath ResearchInstitute on the Vancouver General Hospital site or at aparticipant’s home at baseline (3 months post-surgicalrepair), 6 and 12 months.Primary OutcomeOur primary outcome for this trial is mobility as mea-sured by the Short Physical Performance Battery (SPPB)at 12 months. This valid and reliable measure of mobi-lity has been developed with older adults to assess bal-ance and other key lower extremity functions [44]. TheSPPB is composed of three separate tests that are timedand categorized depending on performance: the testsinclude standing balance, gait speed and sit to standperformance. The SPPB can predict future disability inolder adults [45].Secondary Health OutcomesMobility MeasuresWe will use: (i) the Lower Extremity Measure Scale(LEM) [46], a valid and reliable self-report measuredeveloped specifically for people after hip fracture toassess functional status and to distinguish clinicallyimportant change over time [46]; and (ii) the Timed Upand Go (TUG) Test [47] to assess basic mobilityFigure 1 Flow diagram of the phases of the B4 Clinic trial.Cook et al. BMC Geriatrics 2011, 11:30http://www.biomedcentral.com/1471-2318/11/30Page 3 of 7function related to transfers, balance and walking capa-city. An objective measure of leg strength will becollected.Falls will be measured by self-reported daily fall dia-ries, which will be completed and reported monthly tostudy investigators and followed up by an independentinvestigator. We will also use the QuickScreen to char-acterize components of falls risk. This 10 minute testmeasures key components of falls risk [48] includingperformance based measures (standing balance, coordi-nation, vision, lower extremity sensation and sit-stands)and self-report information on previous falls and medi-cations. We will assess falls-related self-efficacy by theShort-form Falls Efficacy Scale-International [49].FrailtyWe will collect information related to the participants’degree of frailty using two methods: the Clinical FrailtyScale [50], and a frailty index from Fried and colleaguesderived from our study measures [51].Patterns of Physical Activity and Sedentary BehaviourOnce a month we will ask participants to complete aCommunity Healthy Activities Model Program forSeniors (CHAMPS) questionnaire, a valid and reliable 7-day recall self-report tool [52]. We will also ask partici-pants to wear an accelerometer at three time points(baseline, 6 and 12 months) to objectively measure phy-sical activity and sedentary behaviour patterns.Bone HealthWe will record the number of best practice bone healthoptions (i) offered and (ii) utilized by all participants,using a list generated from the 2010 Canadian clinicalpractice guidelines [53] for diagnosis and managementof osteoporosis.Cognitive PerformanceWe will assess global cognition with the Montreal Cog-nitive Assessment (MoCA) [54] and components ofexecutive function using the Trail Making (Part B) [55]and Stroop Colour Word Tests [56].ContinenceUrge incontinence is a risk factor for falls [57,58], andwill be ascertained via screening questions [59].Descriptive DataHospital Medical Chart ReviewWe will collect information regarding previous hospitaladmissions; participants’ health status prior to the hip frac-ture and at discharge, any complications during hospitali-zation for the hip fracture repair and the number ofinpatient visits by physical and occupational therapists andrelated information. We will also check for any falls thatparticipants may have while in hospital. In addition, wewill record assessments of the four research areas (balance,bone health, cognition and continence) and physical ther-apy management that occurs as part of the B4 Clinic.Descriptive InformationWe will capture date of birth, sex, marital status, heightand weight. Body mass index will be calculated asweight (kg)/height × meters2. The Functional Comorbid-ity Index will be used to estimate comorbidities asso-ciated with physical functioning [60]. We will determinepre-fracture function during the week prior to fracture;and will screen for depression [61], and monitor painand fatigue [62].Quality of Life and Health Resource Utilization MeasuresWe will use the EQ-5D-5L, a generic health relatedquality of life measure [63]. This five question measureis easy to administer and can be used in cost-effective-ness studies to evaluate clinical interventions [63].Respondents are asked to rate their health states formobility, self-care, usual activities, pain/discomfort andanxiety/depression. We will use a capability measure,the ICECAP-O [64] to determine the effect of the inter-vention on participants’ quality of life. We will also usea modified health resource utilization questionnaire [65]to capture self-report direct and indirect costs.Process EvaluationWe will use a log to record all eligible participants andwill document reasons for ineligibility or refusal to parti-cipate. Adherence to the B4 Clinic will be monitoredover the course of the intervention, and adverse eventsmonitoring will occur throughout the study. We willinvite participants to complete an exit interview toexamine satisfaction with components of the interven-tion. We will also explore barriers and enablers to parti-cipation in the Clinic services; and specifically we willexamine reasons for low attendance. Finally we willcomplete open-ended qualitative interviews with clinicaland research staff throughout the study to documentour progress. Members of the research team will reviewthe findings from these interviews and adjust researchadministrative procedures if necessary and appropriate.Statistical AnalysisSample SizeWe plan to recruit 130 participants over an 18-monthperiod. Allowing for 15% loss to follow-up we will have110 evaluable participants at 12 months. We have cho-sen to power the study to detect fairly large effect sizesas the proposed intervention represents an intensive useof scarce resources (geriatrician, physical therapists) andwould need to demonstrate large effects to be consid-ered for adoption by health funders. Justification forsample size: Given the anticipated presence of ceilingand/or floor effects in the SPPB we will compare thetwo groups, without adjusting using a Wilcoxon-Mann-Whitney (WMW) test. The WMW test can beCook et al. BMC Geriatrics 2011, 11:30http://www.biomedcentral.com/1471-2318/11/30Page 4 of 7characterized by the WMW odds ratio, ORwmw = π/(1-π) where π = Pr (Y1 < Y2) + 0.5 Pr (Y1 = Y2). Note, ifthere is no difference between the groups, π = 0.5 orequivalently, ORwmw = 1.0. If the ORwmw is 2.0, theodds are 2:1 that Y1 is less than Y2, i.e. π = 2/3. With 55evaluable participants/group we will have >80% powerto detect ORs of 2.0 or greater assuming a = 0.05 (2-sided) [66].Primary analysisAll analyses will be intention-to-treat; there will be nointerim analysis. SPPB at 12 months post randomizationwill be compared between the two groups using theWilcoxon-Mann-Whitney test. Point and interval esti-mates for the difference in medians will be calculated.Secondary analysesAll secondary analyses will be for descriptive purposesonly. Point and interval estimates of the effect of theintervention on LEM scores at 6 and 12 months will bedetermined using a linear mixed model. The baselineLEM score will be included in the model as a covariate.Analyses for frailty, TUG and activity patterns as mea-sured by CHAMPS and accelerometry will follow that ofLEM. Types of management received and adherence toprescribed therapies will be described separately foreach group. Analyses will be conducted at 6 months fordescriptive purposes only.DiscussionWe have adopted the Integrated Knowledge Translationmodel for this project. We recognize the need for post-discharge hip fracture management and have workedtogether with clinicians to develop this model. Our pre-liminary work included interviews with seniors to pilotour outcome measures and better understand barriersand enablers to taking part in exercise after hip fracture.In addition, our team includes knowledge users such asour partners within the local health authority, and clini-cians who work daily with this population. We have pre-viously shown effectiveness of our falls clinic model [67]and now extend this work with a higher risk population.We aim to test a delivery model that would be accepta-ble to both older adults, their caregivers and clinicians;and will complete an economic evaluation in parallel todetermine operating costs and cost-effectiveness andcost-utility of the intervention.AcknowledgementsThe B4 Research Team would like to thank all the clinicians and staff at St.Paul’s Hospital and Vancouver Acute Hospital for their support and expertguidance in the development of this trial. In addition, we would also like tothank staff and colleagues at the Centre for Hip Health and Mobility forongoing support and development of this project. We are grateful to theCanadian Institutes of Health Research (CIHR) for operational support (CIHRDPA – 99051) of this study and the New Investigator Award (MCA). Wewould also like to acknowledge the St. Paul’s Hospital Foundation for salarysupport (WLC) and the Michael Smith Foundation for Health Research(MSFHR) for Career Award support (MCA). Finally, we would also like toacknowledge the support of the British Columbia Network for AgingResearch who provided early funds to investigate older adults’ recoveryprocesses that formed the basis for this research program.Author details1Centre for Hip Health and Mobility, Vancouver, Canada. 2Vancouver CoastalHealth Research Institute, Vancouver, Canada. 3Department of Medicine,University of British Columbia, Vancouver, Canada. 4Providence Health Care,Vancouver, Canada. 5Department of Family Practice, University of BritishColumbia, Vancouver, Canada. 6School of Human Kinetics, University ofBritish Columbia, Vancouver, Canada. 7Centre for Clinical Epidemiology andEvaluation, Vancouver, Canada. 8School of Population and Public Health,University of British Columbia, Vancouver, Canada. 9Department ofOrthopaedics, University of British Columbia, Vancouver, Canada.10Vancouver Coastal Health Authority, Vancouver, Canada.Authors’ contributionsWLC, KMK, PB, PG, HAM, and MCA contributed to the research questiondevelopment and drafting the study protocol. MB, RAB, SB, MGD, HMH, CL,EMM, and JSG contributed to the development of the study protocol anddissemination plan design. WLC and MCA were responsible for drafting thispublication, with significant contribution from KMK and HAM. All teammembers provided input to this manuscript and approved the final version.Competing interestsThe authors declare that they have no competing interests.Received: 6 February 2011 Accepted: 9 June 2011Published: 9 June 2011References1. Wiktorowicz ME, Goeree R, Papaioannou A, Adachi JD, Papadimitropoulos E:Economic implications of hip fracture: health service use, institutionalcare and cost in Canada. Osteoporos Int 2001, 12(4):271-278.2. Braithwaite RS, Col NF, Wong JB: Estimating hip fracture morbidity,mortality and costs. J Am Geriatr Soc 2003, 51(3):364-370.3. Eastwood EA, Magaziner J, Wang J, Silberzweig SB, Hannan EL, Strauss E,Siu AL: Patients with hip fracture: subgroups and their outcomes. J AmGeriatr Soc 2002, 50(7):1240-1249.4. 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J Am Geriatr Soc 2008, 56(10):1821-1830.Pre-publication historyThe pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2318/11/30/prepubdoi:10.1186/1471-2318-11-30Cite this article as: Cook et al.: Post-discharge management followinghip fracture - get you back to B4: A parallel group, randomizedcontrolled trial study protocol. BMC Geriatrics 2011 11:30.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitCook et al. BMC Geriatrics 2011, 11:30http://www.biomedcentral.com/1471-2318/11/30Page 7 of 7