Implementation of supplemental physiotherapy following hip fracture surgery: a protocol for the process evaluation of a randomised controlled trial

Trials. 2024 May 24;25(1):344. doi: 10.1186/s13063-024-08143-4.

Abstract

Background: Patient outcomes following low-trauma hip fracture are suboptimal resulting in increased healthcare costs and poor functional outcomes at 1 year. Providing early and intensive in-hospital physiotherapy could help improve patient outcomes and reduce costs following hip fracture surgery. The HIP fracture Supplemental Therapy to Enhance Recovery (HIPSTER) trial will compare usual care physiotherapy to intensive in-hospital physiotherapy for patients following hip fracture surgery. The complex environments in which the intervention is implemented present unique contextual challenges that may impact intervention effectiveness. This study aims to complete a process evaluation to identify barriers and facilitators to implementation and explore the patient, carer and clinician experience of intensive therapy following hip fracture surgery.

Methods and analysis: The process evaluation is embedded within a two-arm randomised, controlled, assessor-blinded trial recruiting 620 participants from eight Australian hospitals who have had surgery for a hip fracture sustained via a low-trauma injury. A theory-based mixed method process evaluation will be completed in tandem with the HIPSTER trial. Patient and carer semi-structured interviews will be completed at 6 weeks following hip fracture surgery. The clinician experience will be explored through online surveys completed pre- and post-implementation of intensive therapy and mapped to domains of the Theoretical Domains Framework (TDF). Translation and behaviour change success will be assessed using the Reach Effectiveness-Adoption Implementation Maintenance (RE-AIM) framework and a combination of qualitative and quantitative data collection methods. These data will assist with the development of an Implementation Toolkit aiding future translation into practice.

Discussion: The embedded process evaluation will help understand the interplay between the implementation context and the intensive therapy intervention following surgery for low-trauma hip fracture. Understanding these mechanisms, if effective, will assist with transferability into other contexts and wider translation into practice.

Trial registration: ACTRN 12622001442796.

Keywords: Hip fracture; Hospitalisation; Implementation; Physical rehabilitation; Process evaluation.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Australia
  • Fracture Fixation / adverse effects
  • Hip Fractures* / rehabilitation
  • Hip Fractures* / surgery
  • Humans
  • Multicenter Studies as Topic
  • Physical Therapy Modalities*
  • Process Assessment, Health Care
  • Randomized Controlled Trials as Topic*
  • Recovery of Function
  • Time Factors
  • Treatment Outcome