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

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

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
24 May 2024
Historique:
received: 16 01 2024
accepted: 29 04 2024
medline: 25 5 2024
pubmed: 25 5 2024
entrez: 24 5 2024
Statut: epublish

Résumé

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. 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. 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. ACTRN 12622001442796.

Sections du résumé

BACKGROUND 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 METHODS
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 CONCLUSIONS
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 BACKGROUND
ACTRN 12622001442796.

Identifiants

DOI: 10.1186/s13063-024-08143-4 PMID: 38790039
pubmed: 38790039
doi: 10.1186/s13063-024-08143-4
pii: 10.1186/s13063-024-08143-4
doi:

Types de publication

Journal Article Clinical Trial Protocol

Langues

eng

Sous-ensembles de citation

IM

Pagination

344

Subventions

Organisme : Medical Research Future Fund
ID : MRFAR000166

Informations de copyright

© 2024. Crown.

Références

Cooper C, Cole Z, Holroyd C, Earl S, Harvey NC, Dennison EM, et al. Secular trends in the incidence of hip and other osteoporotic fractures. Osteoporos Int. 2011;22:1277–88.
doi: 10.1007/s00198-011-1601-6 pubmed: 21461721 pmcid: 3546313
Ireland AW, Kelly PJ, Cumming RG. State of origin: Australian states use widely different resources for hospital management of hip fracture, but achieve similar outcomes. Aust Health Rev. 2015;40(2):141–8.
doi: 10.1071/AH14181
Australian and New Zealand Hip Fracture Registry. ANZHFR Annual Report of Hip Fracture Care 2019. Australian and New Zealand Hip Fracture Registry, August 2019.
Australian and New Zealand Hip Fracture Registry. ANZHFR Annual Report of Hip Fracture Care 2021. Australian and New Zealand Hip Fracture Registry Australia, September 2021.
Veronese N, Maggi S. Epidemiology and social costs of hip fracture. Injury. 2018;49(8):1458–60.
doi: 10.1016/j.injury.2018.04.015 pubmed: 29699731
Kimmel LA, Liew SM, Sayer JM, Holland AE. HIP4Hips (High Intensity Physiotherapy for Hip fractures in the acute hospital setting): a randomised controlled trial. Med J Aust. 2016;205(2):73–8.
doi: 10.5694/mja16.00091 pubmed: 27456448
Ftouh S, Morga A, Swift C. Management of hip fracture in adults: summary of NICE guidance. BMJ. 2011;342:1.
doi: 10.1136/bmj.d3304
Chehade M, Taylor A. Australian and New Zealand guideline for hip fracture care-improving outcomes in hip fracture management of adults. 2014.
Kimmel LA, Raper E, Ackerman IN, Page R, Naylor J, Burge AT, et al. HIP fracture Supplemental Therapy to Enhance Recovery (HIPSTER): a protocol for a randomised controlled trial. BMJ Open. 2024;14(1):e079846.
doi: 10.1136/bmjopen-2023-079846 pubmed: 38238172 pmcid: 10806657
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258.
doi: 10.1136/bmj.h1258 pubmed: 25791983 pmcid: 4366184
Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061.
doi: 10.1136/bmj.n2061 pubmed: 34593508 pmcid: 8482308
Langhorne P, Wu O, Rodgers H, Ashburn A, Bernhardt J. A Very Early Rehabilitation Trial after stroke (AVERT): a phase III, multicentre, randomised controlled trial. Health Technol Assess. 2017;21(54):1–120.
doi: 10.3310/hta21540 pubmed: 28967376 pmcid: 5641820
McIntyre SA, Francis JJ, Gould NJ, Lorencatto F. The use of theory in process evaluations conducted alongside randomized trials of implementation interventions: a systematic review. Transl Behav Med. 2020;10(1):168–78.
pubmed: 30476259
Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A. Making psychological theory useful for implementing evidence based practice: a consensus approach. BMJ Qual Saf. 2005;14(1):26–33.
doi: 10.1136/qshc.2004.011155
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–7.
doi: 10.2105/AJPH.89.9.1322 pubmed: 10474547 pmcid: 1508772
Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013;103(6):e38–46.
doi: 10.2105/AJPH.2013.301299 pubmed: 23597377 pmcid: 3698732
Huijg JM, Gebhardt WA, Crone MR, Dusseldorp E, Presseau J. Discriminant content validity of a theoretical domains framework questionnaire for use in implementation research. Implement Sci. 2014;9(1):1–16.
doi: 10.1186/1748-5908-9-11
Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012;7:1–17.
doi: 10.1186/1748-5908-7-37
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.
doi: 10.1191/1478088706qp063oa
Boeije H. A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Qual Quant. 2002;36:391–409.
doi: 10.1023/A:1020909529486

Auteurs

Eleanor Raper (E)

Physiotherapy Department, Alfred Health, Melbourne, Australia. eleanor.raper@monash.edu.
Central Clinical School, Monash University, Melbourne, VIC, Australia. eleanor.raper@monash.edu.
ORCID: 0009-0005-3162-5390

Lara A Kimmel (LA)

Physiotherapy Department, Alfred Health, Melbourne, Australia.
School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Angela T Burge (AT)

Physiotherapy Department, Alfred Health, Melbourne, Australia.
Central Clinical School, Monash University, Melbourne, VIC, Australia.
Institute for Breathing and Sleep, Melbourne, VIC, Australia.

Ian A Harris (IA)

Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, Australia.
School of Clinical Medicine, UNSW Medicine & Health, UNSW Sydney, Sydney, Australia.

Ilana N Ackerman (IN)

School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Richard S Page (RS)

Barwon Centre for Orthopaedic Research and Education, IMPACT, School of Medicine, Deakin University, Geelong, VIC, Australia.
John of God Geelong Hospital, Geelong, VIC, Australia.
Department of Orthopaedics, University Hospital Geelong, Barwon Health, Geelong, VIC, Australia.

Justine M Naylor (JM)

Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, Australia.
School of Clinical Medicine, UNSW Medicine & Health, UNSW Sydney, Sydney, Australia.

Graham Hepworth (G)

Statistical Consulting Centre, The University of Melbourne, Melbourne, VIC, Australia.

Belinda Gabbe (B)

School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Christina L Ekegren (CL)

Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, School of Primary and Allied Health Care, Monash University, Melbourne, Australia.

Anthony Harris (A)

Centre for Health Economics, Monash University, Melbourne, Australia.

Maame Esi Woode (ME)

Centre for Health Economics, Monash University, Melbourne, Australia.

Anne E Holland (AE)

Physiotherapy Department, Alfred Health, Melbourne, Australia.
Central Clinical School, Monash University, Melbourne, VIC, Australia.
Institute for Breathing and Sleep, Melbourne, VIC, Australia.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Implementation of supplemental physiotherapy...
questionsmedicales.fr › Plaies et blessures › Traumatismes de la jambe › Fractures du fémur › Fractures de la hanche › Implementation of supplemental physiotherapy...
questionsmedicales.fr › Thérapeutique › Techniques de physiothérapie › Implementation of supplemental physiotherapy...
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questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études multicentriques comme sujet › Implementation of supplemental physiotherapy...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Implementation of supplemental physiotherapy...
questionsmedicales.fr › Phénomènes physiques › Temps › Facteurs temps › Implementation of supplemental physiotherapy...
questionsmedicales.fr › Phénomènes biologiques › Récupération fonctionnelle › Implementation of supplemental physiotherapy...
questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures orthopédiques › Ostéosynthèse › Implementation of supplemental physiotherapy...
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questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de processus en soins de santé › Implementation of supplemental physiotherapy...