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髋部骨折手术后补充物理治疗的实施:一项随机对照试验的过程评估方案。

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

机构信息

Physiotherapy Department, Alfred Health, Melbourne, Australia.

Central Clinical School, Monash University, Melbourne, VIC, Australia.

出版信息

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.

摘要

背景

低创伤性髋部骨折患者的预后不理想,导致医疗保健成本增加,且术后 1 年的功能结果较差。髋部骨折手术后提供早期和强化的院内物理治疗有助于改善患者的预后并降低成本。HIP 骨折补充治疗以增强恢复(HIPSTER)试验将比较髋部骨折手术后常规护理物理治疗与强化院内物理治疗。干预措施实施的复杂环境带来了独特的背景挑战,可能会影响干预措施的有效性。本研究旨在进行一项过程评估,以确定实施过程中的障碍和促进因素,并探讨髋部骨折手术后接受强化治疗的患者、照顾者和临床医生的体验。

方法和分析

该过程评估嵌入在一项为期两年的双臂随机、对照、评估者盲法试验中,该试验从澳大利亚的 8 家医院招募了 620 名接受过低创伤性损伤导致的髋部骨折手术的患者。一项基于理论的混合方法过程评估将与 HIPSTER 试验同时进行。髋部骨折手术后 6 周,将对患者和照顾者进行半结构化访谈。通过在强化治疗实施前后完成在线调查,并将其映射到理论领域框架(TDF)的各个领域,来探索临床医生的经验。使用可达性、有效性、实施和维持(RE-AIM)框架和定性和定量数据收集方法的组合,评估翻译和行为改变的成功率。这些数据将有助于开发一个实施工具包,以帮助未来向实践的转化。

讨论

嵌入式过程评估将有助于理解实施背景与手术后低创伤性髋部骨折强化治疗之间的相互作用。如果有效,了解这些机制将有助于在其他背景下进行转移,并更广泛地向实践推广。

试验注册

ACTRN 12622001442796。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb6f/11127386/ee09f03788a3/13063_2024_8143_Fig1_HTML.jpg

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