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Back to the future - feasibility of recruitment and retention to patient education and telephone follow-up after hip fracture: a pilot randomized controlled trial.

ABSTRACT: OBJECTIVES:Our primary aim of this pilot study was to test feasibility of the planned design, the interventions (education plus telephone coaching), and the outcome measures, and to facilitate a power calculation for a future randomized controlled trial to improve adherence to recovery goals following hip fracture. DESIGN:This is a parallel 1:1 randomized controlled feasibility study. SETTING:The study was conducted in a teaching hospital in Vancouver, BC, Canada. PARTICIPANTS:Participants were community-dwelling adults over 60 years of age with a recent hip fracture. They were recruited and assessed in hospital, and then randomized after hospital discharge to the intervention or control group by a web-based randomization service. Treatment allocation was concealed to the investigators, measurement team, and data entry assistants and analysts. Participants and the research physiotherapist were aware of treatment allocation. INTERVENTION:Intervention included usual care for hip fracture plus a 1-hour in-hospital educational session using a patient-centered educational manual and four videos, and up to five postdischarge telephone calls from a physiotherapist to provide recovery coaching. The control group received usual care plus a 1-hour in-hospital educational session using the educational manual and videos. MEASUREMENT:Our primary outcome was feasibility, specifically recruitment and retention of participants. We also collected selected health outcomes, including health-related quality of life (EQ5D-5L), gait speed, and psychosocial factors (ICEpop CAPability measure for Older people and the Hospital Anxiety and Depression Scale). RESULTS:Our pilot study results indicate that it is feasible to recruit, retain, and provide follow-up telephone coaching to older adults after hip fracture. We enrolled 30 older adults (mean age 81.5 years; range 61-97 years), representing a 42% recruitment rate. Participants excluded were those who were not community dwelling on admission, were discharged to a residential care facility, had physician-diagnosed dementia, and/or had medical contraindications to participation. There were 27 participants who completed the study: eleven in the intervention group, 15 in the control group, and one participant completed a qualitative interview only. There were no differences between groups for health measures. CONCLUSION:We highlight the feasibility of telephone coaching for older adults after hip fracture to improve adherence to mobility recovery goals.

SUBMITTER: Langford DP

PROVIDER: S-EPMC4599063 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Back to the future - feasibility of recruitment and retention to patient education and telephone follow-up after hip fracture: a pilot randomized controlled trial.

Langford Dolores P DP Fleig Lena L Brown Kristin C KC Cho Nancy J NJ Frost Maeve M Ledoyen Monique M Lehn Jayne J Panagiotopoulos Kostas K Sharpe Nina N Ashe Maureen C MC

Patient preference and adherence 20150922

<h4>Objectives</h4>Our primary aim of this pilot study was to test feasibility of the planned design, the interventions (education plus telephone coaching), and the outcome measures, and to facilitate a power calculation for a future randomized controlled trial to improve adherence to recovery goals following hip fracture.<h4>Design</h4>This is a parallel 1:1 randomized controlled feasibility study.<h4>Setting</h4>The study was conducted in a teaching hospital in Vancouver, BC, Canada.<h4>Partic ...[more]

PMID: 26491262

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Project description:BackgroundA Rehabilitation Program for older adults with hip fracture (HIP-REP) based on Activity of Daily Living has been developed. The objectives of this study were to assess the feasibility and safety of the HIP-REP program to inform a future randomized controlled trial (RCT).MethodsA feasibility study Inspired by the Complex-intervention development (Medical Research Council framework phase II) design using quantitative and qualitative research methods were conducted. Eighteen participants (above 65 years) with hip fracture were recruited from the orthopedic wards. The setting was cross sectoral including Copenhagen University Hospital, Herlev and Gentofte and rehabilitation centers in Herlev, Gentofte and Lyngby-Taarbæk municipalities. A cross-sectoral rehabilitation intervention tailored to the needs of older adults with hip fracture highlighting systematic goal setting and strategies focused on activities of daily living was conducted. Pre-defined feasibility criteria: participants recruitment and retention, duration of measuring the outcome, adherence to intervention, and adverse events, along with self-reported outcomes and an objective measurement of performance in activity of daily living. Focus groups were analyzed using a deductive manifest content analysis approach. Descriptive statistical analysis and paired t-tests were performed for assessing change in outcome measures.ResultsRecruitment rate was 4.5/month. Outcome measures were performed but length and number of questionnaires were a burden. Thirteen out of eighteen participants completed the study three dropped out and two died. Adherence among the 13 was 100%. Focus group revealed issues regarding coordinating the intervention, ensuring procedural processes across sectors regarding recruitment of participants, and documentation in the database. Participants expressed satisfaction with the intervention and felt safe during intervention. Assessment of Motor and Process Skills showed better increase between (range 0.4 to 1.6) in ADL motor ability measures and better increase between (range 0.4 to 0.7) for process ability. No clear association between outcome improvements and intervention adherence.ConclusionsThe cross-sectoral intervention based on daily activities was feasible and safe for older adults with hip fracture. A future RCT, with an improved recruitment strategy and reduced number of outcome measures will evaluate the effectiveness in improving independence and safety performance of activity of daily living.Trial registrationClinicalTrials.gov ID: NCT03828240 . Registered on January 29, 2019.

Project description:BackgroundHealth economic evaluations rely on the accurate measurement of health service resource use in order to calculate costs. These are usually measured with patient completed questionnaires using instruments such as the Client Service Receipt Inventory (CSRI). These rely on participants' recall and can be burdensome to complete. Health service activity data are routinely captured by electronic databases.The aim was to test methods for obtaining these data and compare with those data collected using the CSRI, within a feasibility study of an enhanced rehabilitation intervention following hip fracture (Fracture in the Elderly Multidisciplinary Rehabilitation: FEMuR).MethodsPrimary care activity including prescribing data was obtained from the Secure Anonymised Information Linkage (SAIL) Databank and secondary care activity (Emergency Department attendances, out-patient visits and in-patient days) directly from Betsi Cadwaladr University Health Board (BCUHB), North Wales, UK. These data were compared with patient responses from the CSRI using descriptive statistics and the intraclass correlation coefficient (ICC).ResultsIt was possible to compare health service resource use data for 49 out of 61 participants in the FEMuR study. For emergency department (ED) attendances, records matched in 23 (47%) cases, 21 (43%) over-reported on electronic records compared with CSRI and five participants (10%) under-reported, with an overall ICC of 0.42. For out-patient episodes, records matched in only six cases, 28 participants over-reported on electronic records compared with CSRI and 15 (12%) under-reported, with an overall ICC of only 0.27. For in-patient days, records matched exactly in only five cases (10%), but if an error margin of 7 days was allowed, then agreement rose to 39 (66%) cases, and the overall ICC for all data was 0.88.It was only possible to compare prescribing data for 12 participants. For prescribing data, the SAIL data reported 117 out of 118 items (99%) and the CSRI only 89 (79%) items.ConclusionsThe use of routinely collected data has the potential to improve the efficiency of trials and other studies. Although the methodology to make the data available has been demonstrated, the data obtained was incomplete and the validity of using this method remains to be demonstrated.Trial registrationTrial registration: ISRCTN22464643 Registered 21 July 2014.

Project description:OBJECTIVES:The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal. DESIGN:A two-arm, parallel, assessor-blinded, feasibility RCT. SETTING:A rehabilitation hospital in Kathmandu, Nepal. PARTICIPANTS:Forty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women). INTERVENTIONS:Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session. PRIMARY OUTCOME MEASURES:The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment. SECONDARY OUTCOME MEASURES:Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation. RESULTS:Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported. CONCLUSION:We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted. TRIAL REGISTRATION NUMBER:NCT03387228; Results.

Project description:ImportancePatients with a hip fracture lose more than 50% knee-extension strength in the fractured limb within one week of surgery. Hence, immediate progressive strength training following hip fracture surgery may be rational, but the feasibility unknown.ObjectiveTo examine the feasibility of in-hospital progressive strength training implemented in the acute ward following hip fracture surgery, based on pre-specified criteria for feasibility.Design, setting and patientsA prospective cohort study conducted in an acute orthopedic hip fracture unit at a university hospital. A consecutive sample of 36 patients, 18 with a cervical and 18 with a trochanteric hip fracture (27 women and 9 men, mean (SD) age of 79.4 (8.3) years) were included between June and December 2012.InterventionA daily (on weekdays) program of progressive knee-extension strength training for the fractured limb, using ankle weight cuffs in 3 sets of 10 repetition maximum loadings.Main outcomes and measuresThe primary outcome was the change in training load (kg) during the knee-extension strength training. The secondary outcomes were changes in hip fracture-related pain and maximal isometric knee-extension strength.ResultsThe strength training was commenced at a mean of 2.4 (0.7) days after surgery. The training loads (kilograms lifted) increased from 1.6 (0.8) to 4.3 (1.7) kg over 4.3 (2.2) training sessions (P<.001). The maximal isometric knee-extension strength of the fractured limb increased from 0.37 (0.2) to 0.61 (0.3) Nm/kg (P<.001), while the average strength deficit in the fractured limb decreased from 50% to 32% (% non-fractured, P<.001). Only 3 of 212 sessions were not performed because of severe hip fracture-related pain.Conclusion and relevanceProgressive knee-extension strength training of the fractured limb commenced in the acute ward seems feasible, and may reduce strength asymmetry between limbs without hip pain interfering. The clinical efficacy needs confirmation in a randomized controlled design.Trial registrationClinicalTrials.gov ID: NCT01616030.

Project description:IntroductionGuidelines for hip fracture care state that patients with hip fracture should be mobilised on the day after surgery and at least once a day thereafter. However, compliance with these guidelines is poor. One approach that would assist physiotherapists to meet mobility guidelines after hip fracture is to delegate the provision of daily mobilisation to allied health assistants under their supervision. Therefore, we plan to conduct a randomised controlled trial to determine the feasibility of an allied health assistant providing daily inpatient rehabilitation to patients with hip fracture.Methods and analysisUsing a parallel group randomised controlled design with one-to-one allocation, participants will be randomly allocated to an experimental group (allied health assistant management) or a comparison group (physiotherapist management). Inclusion criteria are: adult with diagnosis of hip fracture; inpatient in acute hospital; walked independently pre-hip fracture and able to communicate in conversational English. The experimental group will receive routine physiotherapy rehabilitation, including daily mobilisation, from an allied health assistant following initial physiotherapist assessment. The comparison group will receive routine rehabilitation from a physiotherapist. The primary outcome will be the feasibility of allied health assistant management of patients with hip fracture. Feasibility will be determined using the following areas of focus in Bowen's feasibility framework: acceptability (patient satisfaction), demand (proportion of patients who participate), implementation (time allied health assistant/physiotherapist spends with participant, occasions of service) and practicality (cost, adverse events). Staff involved in the implementation of allied health assistant care will be interviewed to explore their perspectives on feasibility. Secondary outcomes include compliance with daily mobilisation guidelines, discharge destination, hospital readmission, falls, functional activity and length of stay. We aim to recruit 50 participants. Descriptive statistics will be used to describe feasibility and mobilisation rates will be calculated using Cox proportional hazards regression to compare compliance with mobilisation guidelines.Ethics and disseminationEthics approval was obtained from the Peninsula Health human research ethics committee (HREC/63 005/PH-2020). The findings will be disseminated in peer-reviewed journals and conference presentations.Trail registration numberAustralian and New Zealand Clinical Trial Registry; ACTRN12620000877987; Pre-results.

Dataset Information

Back to the future - feasibility of recruitment and retention to patient education and telephone follow-up after hip fracture: a pilot randomized controlled trial.

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Back to the future - feasibility of recruitment and retention to patient education and telephone follow-up after hip fracture: a pilot randomized controlled trial.

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