Protocol for a feasibility randomised controlled trial of the 'Outdoor' mobility intervention for older adults after hip fracture.

Background: A high proportion of patients do not regain outdoor mobility after hip fracture. Rehabilitation explicitly targeting outdoor mobility is needed to enable these older adults to recover activities which they value most. The overarching aim of this study is to determine the feasibility of a randomised controlled trial which aims to assess the clinical- and cost-effectiveness of an intervention designed to enable recovery of outdoor mobility among older adults after hip fracture (the OUTDOOR intervention).
Methods: This is a protocol for a multi-centre pragmatic parallel group (allocation ratio 1:1) randomised controlled assessor-blinded feasibility trial. Adults aged 60 years or more, admitted to hospital from- and planned discharge to- home, with self-reported outdoor mobility in the three-months pre-fracture, surgically treated for hip fracture, and who are able to consent and participate, are eligible. Individuals who require two or more people to support mobility on discharge will be excluded. Screening and consent (or consent to contact) will take place in hospital. Baseline assessment and randomisation will follow discharge from hospital. Participants will then receive usual care (delivered by physiotherapy, occupational therapy, or therapy assistants), or usual care plus the OUTDOOR intervention. The OUTDOOR intervention includes a goal-orientated outdoor mobility programme (supported by up to six in-person visits), therapist-led motivational dialogue (supported by up to four telephone calls), supported by a past-patient led video where recovery experiences are shared, and support to transition to independent ongoing recovery. Therapists delivering the OUTDOOR intervention (distinct from those supporting usual care) will receive training in motivational interviewing and behaviour change techniques. Baseline demographics will be collected. Patient reported outcome measures including health related quality of life, activities of daily living, pain, community mobility, falls related self-efficacy, resource use, readmissions, and mortality will be collected at baseline, 6-weeks, 12-weeks, and 6-months (for those enrolled early in the trial) post-randomisation. Exercise adherence (6- and 12- weeks) and intervention acceptability (12-weeks) will be collected. A subset of 20 participants will also support accelerometery data collection for 10 days at each time point.
Dissemination: The trial findings will be disseminated to patients and the public, health professionals and researchers through publications, presentations and social media channels.
Trial Registration: The trial has been registered at ISRCTN16147125.
Protocol Version: 3.0.
Competing Interests: The authors have received grants from the National Institutes of Health Research (NIHR) and The Royal Osteoporosis Society related to this work. This funding provides salary support for DB, and partial salary support for SC, CH, SL, CS, EG and KS. KS receives funding from UKRI for hip fracture health services research. KS is Chair of the Scientific and Publications Committee at the Falls and Fragility Fracture National Audit programme and the Chair-elect of the Scientific Committee of the Fragility Fracture Network. CS, TS, SC receive funding from the National Institutes of Health Research for research not related to the current study. SC is partially supported by the National Institute for Health Research Applied Research Collaboration South West Peninsula. DS, SG, SP, FM declare no additional conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
(Copyright: © 2024 Sheehan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)