Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multi-centre randomised controlled feasibility trial with embedded qualitative study in England.

Smith, Toby O. ORCID: https://orcid.org/0000-0003-1673-2954, Khoury, Reema, Hanson, Sarah ORCID: https://orcid.org/0000-0003-4751-8248, Welsh, Allie ORCID: https://orcid.org/0000-0001-8278-6673, Grant, Kelly, Clark, Allan B. ORCID: https://orcid.org/0000-0003-2965-8941, Ashford, Polly-Anna, Hopewell, Sally, Pfeiffer, Klaus, Logan, Pip A., Crotty, Maria, Costa, Matthew L. and Lamb, Sallie and on behalf of the HIP HELPER Study Collaborators (2023) Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multi-centre randomised controlled feasibility trial with embedded qualitative study in England. BMJ Open, 13 (12). ISSN 2044-6055

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Abstract

Objectives To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. Design Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study. Setting National Health Service (NHS) providers in five English hospitals. Participants Community-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers. Intervention Usual care: usual NHS care. Experimental: usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions. Randomisation and blinding Central randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding. Main outcome measures Data collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals. Results 102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515/1311) of patients screened were eligible. Eleven per cent (56/515) of eligible patients consented to be randomised. Forty-eight per cent (12/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable. Conclusions The HIP HELPER programme was acceptable to patient-caregiver dyads and health professionals. The COVID-19 pandemic impacting on site's ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT. Trial registration number ISRCTN13270387.

Item Type: Article
Additional Information: Data availability statement: Data are available upon reasonable request. Data includes access to the full protocol, anonymised participant level dataset and statistical code. Access to the de-identified dataset for purposes of research other than this study, would be at the discretion of the Chief Investigator, TOS and Norwich CTU. Requests for the de-identified dataset generated during the current study should be made to the Chief Investigator, TOS. TOS and Norwich CTU will consider requests once the main results from the study have been published up until 31st December 2028. Funding information: This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR200731). SL role in this study was supported by the National Institute for Health and Care Research Exeter Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Uncontrolled Keywords: trauma,femoral fracture,recovery,rehabilitation,domiciliary,carer,home network,rct,rehabilitation medicine,nursing care,orthopaedic & trauma surgery,hip,medicine(all),2* ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Centres > Population Health
Faculty of Science > Research Groups > Norwich Epidemiology Centre
Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre
Faculty of Medicine and Health Sciences > Research Groups > Health Promotion
Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging
Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health
Faculty of Medicine and Health Sciences > Research Groups > Rehabilitation
Faculty of Medicine and Health Sciences > Research Groups > Epidemiology and Public Health
Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit
Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care
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Depositing User: LivePure Connector
Date Deposited: 22 Nov 2023 04:37
Last Modified: 03 Jan 2024 03:17
URI: https://ueaeprints.uea.ac.uk/id/eprint/93700
DOI: 10.1136/bmjopen-2023-073611

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