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

Toby O. Smith; Reema Khoury; Sarah Hanson; Allie Welsh; Kelly Grant; Allan B. Clark; Polly Anna Ashford; Sally Hopewell; K. Pfeiffer; Phillipa Logan; Maria Crotty; Matthew L. Costa; Sarah Lamb; The HIP HELPER Study Collaborators

doi:10.1136/bmjopen-2023-073611

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

Toby O. Smith, Reema Khoury, Sarah Hanson, Allie Welsh, Kelly Grant, Allan B. Clark, Polly Anna Ashford, Sally Hopewell, K. Pfeiffer, Phillipa Logan, Maria Crotty, Matthew L. Costa, Sarah Lamb, The HIP HELPER Study Collaborators

College of Medicine and Public Health

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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.

Original language	English
Article number	e073611
Number of pages	11
Journal	BMJ Open
Volume	13
Issue number	12
DOIs	https://doi.org/10.1136/bmjopen-2023-073611
Publication status	Published - 9 Dec 2023

Keywords

hip
nursing care
orthopaedic & trauma surgery
rehabilitation medicine

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10.1136/bmjopen-2023-073611Licence: CC BY

Final published versionFinal published version, 807 KBLicence: CC BY

Cite this

Smith, T. O., Khoury, R., Hanson, S., Welsh, A., Grant, K., Clark, A. B., Ashford, P. A., Hopewell, S., Pfeiffer, K., Logan, P., Crotty, M., Costa, M. L., Lamb, S., & The HIP HELPER Study Collaborators (2023). Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England. BMJ Open, 13(12), Article e073611. https://doi.org/10.1136/bmjopen-2023-073611

@article{40b802128ca74e3b86f895a9836d7919,

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

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.",

keywords = "hip, nursing care, orthopaedic & trauma surgery, rehabilitation medicine",

author = "Smith, {Toby O.} and Reema Khoury and Sarah Hanson and Allie Welsh and Kelly Grant and Clark, {Allan B.} and Ashford, {Polly Anna} and Sally Hopewell and K. Pfeiffer and Phillipa Logan and Maria Crotty and Costa, {Matthew L.} and Sarah Lamb and {The HIP HELPER Study Collaborators} and Penny Clifford and Lis Freeman and Rene Gray and Yan Cunningham and Sarah Langford and Mark Baxter and Jessica Pawson and Melissa Taylor and Anna Mellows and Kate Lacey and Alex Herring and Diane Williams and Anna Cromie and Gail Menton and Warren Corbett and Helen Jowett and Vishwanath Joshi and Maninderpal Matharu and David Barker and Susan Dutton and Opinder Sahota and Katie Sheehan",

year = "2023",

month = dec,

day = "9",

doi = "10.1136/bmjopen-2023-073611",

language = "English",

volume = "13",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "group.bmj.com",

number = "12",

}

Smith, TO, Khoury, R, Hanson, S, Welsh, A, Grant, K, Clark, AB, Ashford, PA, Hopewell, S, Pfeiffer, K, Logan, P, Crotty, M, Costa, ML, Lamb, S & The HIP HELPER Study Collaborators 2023, 'Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England', BMJ Open, vol. 13, no. 12, e073611. https://doi.org/10.1136/bmjopen-2023-073611

TY - JOUR

T1 - Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER)

T2 - multicentre randomised controlled feasibility trial with embedded qualitative study in England

AU - Smith, Toby O.

AU - Khoury, Reema

AU - Hanson, Sarah

AU - Welsh, Allie

AU - Grant, Kelly

AU - Clark, Allan B.

AU - Ashford, Polly Anna

AU - Hopewell, Sally

AU - Pfeiffer, K.

AU - Logan, Phillipa

AU - Crotty, Maria

AU - Costa, Matthew L.

AU - Lamb, Sarah

AU - The HIP HELPER Study Collaborators

AU - Clifford, Penny

AU - Freeman, Lis

AU - Gray, Rene

AU - Cunningham, Yan

AU - Langford, Sarah

AU - Baxter, Mark

AU - Pawson, Jessica

AU - Taylor, Melissa

AU - Mellows, Anna

AU - Lacey, Kate

AU - Herring, Alex

AU - Williams, Diane

AU - Cromie, Anna

AU - Menton, Gail

AU - Corbett, Warren

AU - Jowett, Helen

AU - Joshi, Vishwanath

AU - Matharu, Maninderpal

AU - Barker, David

AU - Dutton, Susan

AU - Sahota, Opinder

AU - Sheehan, Katie

PY - 2023/12/9

Y1 - 2023/12/9

N2 - 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.

AB - 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.

KW - hip

KW - nursing care

KW - orthopaedic & trauma surgery

KW - rehabilitation medicine

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U2 - 10.1136/bmjopen-2023-073611

DO - 10.1136/bmjopen-2023-073611

M3 - Article

C2 - 38070926

AN - SCOPUS:85179646448

SN - 2044-6055

VL - 13

JO - BMJ Open

JF - BMJ Open

IS - 12

M1 - e073611

ER -

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

Abstract

Keywords

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