Structured tailored rehabilitation after hip fragility fracture: The ‘Stratify’ feasibility and pilot randomised controlled trial protocol

Sheehan, Katie J.; Guerra, Stefanny; Ayis, Salma; Goubar, Aicha; Foster, Nadine E.; Martin, Finbarr C.; Godfrey, Emma; Cameron, Ian D.; Gregson, Celia L.; Walsh, Nicola E.; Ferguson Montague, Anna; Edwards, Rebecca; Adams, Jodie; Jones, Gareth D.; Gibson, Jamie; Sackley, Catherine; Whitney, Julie

Abstract

Background: Rehabilitation in hospital is effective in reducing mortality after hip fracture. However, there is uncertainty over optimal in-hospital rehabilitation treatment ingredients, and the generalizability of trial findings to subgroups of patients systematically excluded from previous trials. The aim of this study is to determine the feasibility of a randomized controlled trial which aims to assess the clinical- and cost-effectiveness of adding a stratified care intervention to usual care designed to improve outcomes of acute rehabilitation for all older adults after hip fracture. Methods: This is a protocol for a single site, feasibility and pilot, pragmatic, parallel group (allocation ratio 1:1) randomised controlled assessor-blind STRATIFY trial (Structured Tailored Rehabilitation AfTer HIp FragilitY Fracture). Adults aged 60 years or more, surgically treated for hip fracture following low energy trauma (fragility fracture), who are willing to provide consent or by consultee declaration (depending on capacity), are eligible. Individuals who experienced in-hospital hip fracture will be excluded. Screening, consent/assent, baseline assessment (demographics, patient reported outcome measures or PROMs [health related quality of life, activities of daily living, pain, falls related self-efficacy], and resource use), and randomization will take place within the first four days post-admission. Participants will then be offered usual care, or usual care plus STRATIFY intervention during their hospital stay. The STRATIFY intervention includes 1) a web-based algorithm to allocate participants to low- medium- or high-risk subgroups; and 2) matched interventions depending on subgroup allocation. The low-risk subgroup will be offered a self-management review, training in advocacy, and a self-managed exercise programme with support for progression, in addition to usual care (1-hour 40 minutes therapist time above usual care). The medium-risk subgroup will be offered education, a goal-orientated mobility programme (with carer training, as available and following carer consent), and early enhanced discharge planning, in addition to usual care (estimated 2-hours 15 minutes therapist time above usual care). The high-risk subgroup will be offered education, enhanced assessment, orientation, and a goal-orientated activities of daily living programme (with carer training, as available and following carer consent), in addition to usual care (estimated 2-hours 45minutes therapist time above usual care). All STRATIFY subgroup treatment interventions are specified using the Rehabilitation Treatment Specification System (RTSS) for treatment theory development and replication. Follow-up PROM data collection, RESOURCE USE alongside readmissions and mortality, will be collected on discharge and 12-weeks post-randomisation. Intervention acceptability will be determined by semi-structured interviews with participants, carers, and therapists at the end of the intervention. 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 clinicaltrials.gov (NCT06014554).

• Journal Article Type: Article
• Acceptance Date: Jun 18, 2024
• Online Publication Date: Dec 17, 2024
• Publication Date: Dec 17, 2024
• Deposit Date: Jan 14, 2025
• Publicly Available Date: Jan 14, 2025
• Journal: PLOS ONE
• Electronic ISSN: 1932-6203
• Publisher: Public Library of Science
• Peer Reviewed: Peer Reviewed
• Volume: 19
• Issue: 12
• Article Number: e0306870
• DOI: https://doi.org/10.1371/journal.pone.0306870
• Public URL: https://uwe-repository.worktribe.com/output/13540538