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

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Rehabilitation medicine
Original research
Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England
  1. Toby O Smith1,2,
  2. Reema Khoury3,
  3. Sarah Hanson2,
  4. Allie Welsh4,
  5. Kelly Grant3,
  6. Allan B Clark3,
  7. Polly-Anna Ashford3,
  8. Sally Hopewell5,
  9. K Pfeiffer6,
  10. Phillipa Logan7,
  11. Maria Crotty8,
  12. Matthew L Costa5,
  13. Sarah Lamb5,9
  14. The HIP HELPER Study Collaborators
    1. 1Warwick Medical School, University of Warwick, Coventry, UK
    2. 2School of Health Sciences, University of East Anglia, Norwich, UK
    3. 3Norwich Medical School, University of East Anglia, Norwich, UK
    4. 4School of Education, University of East Anglia, Norwich, UK
    5. 5Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
    6. 6Department of Clinical Gerontology and Geriatric Rehabilitation, Robert Bosch Hospital, Stuttgart, Germany
    7. 7School of Medicine, University of Nottingham, Nottingham, UK
    8. 8College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia
    9. 9College of Medicine and Health, University of Exeter, Exeter, UK
    1. Correspondence to Professor Toby O Smith; toby.smith{at}uea.ac.uk

    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.

    • orthopaedic & trauma surgery
    • hip
    • rehabilitation medicine
    • nursing care

    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 (email: toby.o.smith@warwick.ac.uk) or Norwich CTU (NorwichCTU@uea.ac.uk). TOS and Norwich CTU will consider requests once the main results from the study have been published up until 31st December 2028.

    https://creativecommons.org/licenses/by/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    https://doi.org/10.1136/bmjopen-2023-073611

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      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 (email: toby.o.smith@warwick.ac.uk) or Norwich CTU (NorwichCTU@uea.ac.uk). TOS and Norwich CTU will consider requests once the main results from the study have been published up until 31st December 2028.

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      Footnotes

      • Twitter @tobyosmith, @walkingresearch, @alliecwelsh

      • Collaborators The HIP HELPER Study Collaborators: Penny Clifford (Norfolk, PPI Representative), Lis Freeman (Norfolk, PPI Representative), Rene Gray (Principal Investigator—James Paget University Hospital NHS Trust), Yan Cunningham (Principal Investigator—City Hospitals Sunderland NHS Foundation Trust), Sarah Langford (Principal Investigator—Northumbria Healthcare NHS Foundation Trust), Dr Mark Baxter (Principal Investigator—University Hospital Southampton NHS Foundation Trust), Jessica Pawson—(Principal Investigator—Barts Health NHS Trust), Melissa Taylor (James Paget University Hospital NHS Trust), Anna Mellows (James Paget University Hospital NHS Trust), Kate Lacey (James Paget University Hospital NHS Trust), Alex Herring (City Hospital Sunderland NHS Foundation Trust), Diane Williams (Northumbria Healthcare NHS Foundation Trust), Anna Cromie (Northumbria Healthcare NHS Foundation Trust), Gail Menton (Northumbria Healthcare NHS Foundation Trust), Warren Corbett (University Hospital Southampton NHS Foundation Trust), Helen Jowett (University Hospital Southampton NHS Foundation Trust), Vishwanath Joshi (Barts Health NHS Trust), Maninderpal Matharu (Barts Health NHS Trust), Maria Baggot (University Hospital Southampton NHS Foundation Trust),and David Barker (University Hospital Southampton NHS Foundation Trust). Oversight Committee Membership: TOC Members: Associate Professor Susan Dutton (Chair; University of Oxford, UK), Professor Opinder Sahota (University of Nottingham, UK), Dr Katie Sheehan (Kings College London, UK).

      • Contributors TOS, SHa, SHo, ABC, KG, P-AA, KP, PL, MLC, SL and MC researched the topic and devised the study. TOS, SHa, P-AA, RK, ABC, KG, SHo, AW, KP, PL, MLC, SL, MC provided the first draft of the manuscript. ABC provided statistical oversight. TOS, SHa, P-AA, RK, ABC, KG, AW, SHo, KP, PL, MC, SL and MLC contributed equally to manuscript preparation. TOS acts a guarantor.

      • Funding 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.

      • Disclaimer MLC and SHo are supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). SL is 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 NHS, the NIHR or the Department of Health and Social Care.

      • Competing interests None declared.

      • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.