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Mixed methods process evaluation of an enhanced community-based rehabilitation intervention for elderly patients with hip fracture.

ABSTRACT: To describe the implementation of an enhanced rehabilitation programme for elderly hip fracture patients with mental capacity, in a randomised feasibility study compared with usual rehabilitation. To compare processes between the two and to collect the views of patients, carers and therapy staff about trial participation.Mixed methods process evaluation in a randomised feasibility study.Patient participants were recruited on orthopaedic and rehabilitation wards; the intervention was delivered in the community following hospital discharge.Sixty-one older adults (aged ?65 years) recovering from surgical treatment (replacement arthroplasty or internal fixation) following hip fracture, who were living independently prior to fracture and had mental capacity and 31 of their carers.Usual care (control) or usual care plus an enhanced rehabilitation package (intervention). The enhanced rehabilitation consisted of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions.Recruitment of sites and rehabilitation teams, response of rehabilitation teams, recruitment and reach in patient and carer participants, intervention delivery, delivery to individuals, response of individual patients to the enhanced intervention or usual rehabilitation, response of carer participants, unintended consequences and testing intervention theory and context.Usual rehabilitation care was very variable. The enhanced rehabilitation group received a mean of five additional therapy sessions. All of the returned goal-setting diaries had inputs from the therapy team, and half had written comments by the patients and carers. Focus group themes: variation of usual care and its impact on delivering the intervention; the importance of goal setting; the role of the therapist in providing reassurance about safe physical activities; and acceptability of the extra therapy sessions.Lessons learnt for a future definitive RCT include how to enhance recruitment and improve training materials, the workbook, delivery of the extra therapy sessions and recording of usual rehabilitation care.ISRCTN22464643; Post- results.

SUBMITTER: Roberts JL

PROVIDER: S-EPMC6089270 | biostudies-other | 2018 Aug

REPOSITORIES: biostudies-other

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Mixed methods process evaluation of an enhanced community-based rehabilitation intervention for elderly patients with hip fracture.

Roberts Jessica Louise JL Pritchard Aaron W AW Williams Michelle M Totton Nikki N Morrison Val V Din Nafees Ud NU Williams Nefyn H NH

BMJ open 20180808 8

<h4>Objectives</h4>To describe the implementation of an enhanced rehabilitation programme for elderly hip fracture patients with mental capacity, in a randomised feasibility study compared with usual rehabilitation. To compare processes between the two and to collect the views of patients, carers and therapy staff about trial participation.<h4>Design</h4>Mixed methods process evaluation in a randomised feasibility study.<h4>Setting</h4>Patient participants were recruited on orthopaedic and rehab ...[more]

PMID: 30093516

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Project description:IntroductionProximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care.Methods and analysisProtocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme.Ethics and disseminationNational Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.Trial registration numberISRCTN28376407; Pre-results registered on 23 November 2018.

Project description:BACKGROUND:Community-based rehabilitation (CBR), or community-based inclusive development, is an approach to address the complex health, social and economic needs of people with schizophrenia in low and middle-income countries. Formative work was undertaken previously to design a culturally appropriate CBR intervention for people with schizophrenia in Ethiopia. The current study explored the acceptability and feasibility of CBR in practice, as well as how CBR may improve functioning among people with schizophrenia. METHODS:This mixed methods pilot study took place in rural Ethiopia between December 2014 and December 2015. Ten people with schizophrenia who were unresponsive to treatment with medication alone, and their caregivers, participated in CBR. CBR was led by lay workers with five weeks training and involved home visits (education, family intervention and support returning to work) and community mobilisation. Theory of change was used to guide the pilot evaluation. Qualitative and quantitative data were collected at baseline, six months and 12 months. Forty in-depth interviews and two focus group discussions were conducted with 31 individuals comprising people with schizophrenia, caregivers, CBR workers, supervisors, health officers and community members. RESULTS:The RISE CBR intervention may have a positive impact on functioning through the pathways of enhanced family support, improved access to health care, increased income and improved self-esteem. CBR was acceptable to CBR workers, community leaders and health officers. Some CBR workers found it challenging to accept the choices of people with schizophrenia. These concerns were felt to be resolvable with supplementary training for CBR workers. The intervention was feasible but further evaluation is needed on a larger scale. CONCLUSION:In low and middle-income countries, CBR may be an acceptable and feasible adjuvant approach to facility-based care for people with schizophrenia. However, contextual factors, including poverty and inaccessible anti-psychotic medication, remain substantial challenges. There were indications that CBR can impact on functioning but the RISE trial will determine effectiveness.

Project description:BackgroundThis study describes the process evaluation of an intervention developed to reduce fear of falling (FoF) after hip fracture, within an inpatient geriatric rehabilitation setting. This 'FIT-HIP intervention' is a multicomponent cognitive behavioral intervention, conducted by physiotherapists and embedded in usual care in geriatric rehabilitation in the Netherlands. A previous study (cluster randomized controlled trial) showed no beneficial effects of this intervention when compared to usual care. The aim of this study was to gain insight into factors related to the intervention process that may have influenced the effectiveness of the intervention.MethodsThis process evaluation was conducted using an observational prospective study design. Based on quantitative and qualitative data derived from session logs, evaluation questionnaires and interviews, we addressed: 1] recruitment and reach; 2] performance according to protocol; 3] patients' adherence; and 4] opinions of patients and facilitators on the intervention. Participants in this study were: a) patients from 6 geriatric rehabilitation units, who were invited to participate in the intervention (39 adults aged ≥65 years with hip fracture and FoF) and; b) intervention facilitators (14 physiotherapists and 8 psychologists who provide coaching to the physiotherapists).ResultsThirty-six patients completed the intervention during inpatient geriatric rehabilitation. Apart from cognitive restructuring and telephonic booster (which was not provided to all patients), the intervention was performed to a fair degree in accordance with protocol. Patients' adherence to the intervention was very good, and patients rated the intervention positively (average 8.1 on a scale 0-10). Although most facilitators considered the intervention feasible, a limited level of FoF (possibly related to timing of intervention), and physiotherapists' limited experience with cognitive restructuring were identified as important barriers to performing the intervention according to protocol.ConclusionsThe FIT-HIP intervention was only partly feasible, which may explain the lack of effectiveness in reducing FoF. To improve the intervention's feasibility, we recommend selecting patients with maladaptive FoF (i.e. leading to activity restriction), being more flexible in the timing of the intervention, and providing more support to the physiotherapists in conducting cognitive restructuring.Trial registrationNetherlands Trial Register: NTR5695 (7 March 2016).

Project description:Background:Malnutrition after hip fracture is associated with increased rehabilitation time, complications, and mortality. We assessed the effect of intensive 3 month nutritional intervention in elderly after hip fracture on length of stay (LOS). Methods:Open-label, randomized controlled trial. Exclusion criteria: age < 55 years, bone disease, life expectancy < 1 year, bedridden, using oral nutritional supplements (ONS) before hospitalization, and cognitive impairment. Intervention: weekly dietetic consultation, energy-protein-enriched diet, and ONS (400 mL per day) for 3 months. Control: usual nutritional care. Primary outcome: total LOS in hospital and rehabilitation clinic, including readmissions over 6 months (Cox regression adjusted for confounders); hazard ratio (HR) < 1.0 reflects longer LOS in the intervention group. Secondary outcomes: nutritional and functional status, cognition, quality of life, postoperative complications (6 months); subsequent fractures and all-cause mortality (1 and 5 years). Effect modification by baseline nutritional status was also tested. Results:One hundred fifty-two patients were randomized (73 intervention, 79 control). Median total LOS was 34.0 days (range 4-185 days) in the intervention group versus control 35.5 days (3-183 days; plogrank = .80; adjusted hazard ratio (adjHR): 0.98; 95% CI: 0.68-1.41). Hospital LOS: 12.0 days (4-56 days) versus 11.0 days (3-115 days; p = .19; adjHR: 0.75; 95% CI: 0.53-1.06) and LOS in rehabilitation clinics: 19.5 days (0-174 days) versus 18.5 days (0-168 days; p = .82; adjHR: 1.04; 95% CI: 0.73-1.48). The intervention improved nutritional intake/status at 3, but not at 6 months, and did not affect any other outcome. No difference in intervention effect between malnourished and well-nourished patients was found. Conclusions:Intensive nutritional intervention after hip fracture improved nutritional intake and status, but not LOS or clinical outcomes. Paradigms underlying nutritional intervention in elderly after hip fracture may have to be reconsidered.

Project description:UnlabelledHip fracture patients can benefit from nutritional supplementation during their recovery. Up to now, cost-effectiveness evaluation of nutritional intervention in these patients has not been performed. Costs of nutritional intervention are relatively low as compared with medical costs. Cost-effectiveness evaluation shows that nutritional intervention is likely to be cost-effective.IntroductionPrevious research on the effect of nutritional intervention on clinical outcome in hip fracture patients yielded contradictory results. Cost-effectiveness of nutritional intervention in these patients remains unknown. The aim of this study was to evaluate cost-effectiveness of nutritional intervention in elderly subjects after hip fracture from a societal perspective.MethodsOpen-label, multi-centre randomized controlled trial investigating cost-effectiveness of intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation for 3 months postoperatively. Patients allocated to the control group received care as usual. Costs, weight and quality of life were measured at baseline and at 3 and 6 months postoperatively. Incremental cost-effectiveness ratios (ICERs) were calculated for weight at 3 months and quality adjusted life years (QALYs) at 6 months postoperatively.ResultsOf 152 patients enrolled, 73 were randomized to the intervention group and 79 to the control group. Mean costs of the nutritional intervention was 613 Euro. Total costs and subcategories of costs were not significantly different between both groups. Based on bootstrapping of ICERs, the nutritional intervention was likely to be cost-effective for weight as outcome over the 3-month intervention period, regardless of nutritional status at baseline. With QALYs as outcome, the probability for the nutritional intervention being cost-effective was relatively low, except in subjects aged below 75 years.ConclusionIntensive nutritional intervention in elderly hip fracture patients is likely to be cost-effective for weight but not for QALYs. Future cost-effectiveness studies should incorporate outcome measures appropriate for elderly patients, such as functional limitations and other relevant outcome parameters for elderly.

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Mixed methods process evaluation of an enhanced community-based rehabilitation intervention for elderly patients with hip fracture.

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Mixed methods process evaluation of an enhanced community-based rehabilitation intervention for elderly patients with hip fracture.

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