A study to improve the care pathways for people, 60 years and over, in South Asia with a broken hip
| ISRCTN | ISRCTN23534273 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23534273 |
| Secondary identifying numbers | NIHR203194 |
- Submission date
- 12/06/2024
- Registration date
- 11/07/2024
- Last edited
- 18/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
A broken hip (hip fracture) is a serious injury that requires surgery to repair or replace the broken bone followed by a long period in hospital to recover. Older adults are more likely to break their hip as their bones are weakened by a health condition known as osteoporosis. Around a quarter of patients with hip fractures die within a year and those that survive have a permanent loss of quality of life. Looking after older, often frail, patients following a hip fracture requires healthcare professionals from many different backgrounds. These include surgeons, doctors specialising in looking after older patients, nurses and therapists. In the UK, a collaborative approach between all healthcare professionals in taking care of these patients has reduced the number of people dying after hip fracture and improved their quality of life. It has also reduced healthcare costs. Asia is particularly affected by rapidly ageing populations. The number of people experiencing hip fractures is expected to increase from 1.1 million now to 2.6 million in 2050. This study is about testing the benefits of such ‘multi-disciplinary’ care in low- and middle-income countries (LMIC) in Asia. The HIPCARE study will test a multi-disciplinary care approach in five LMICs: India, Nepal, Philippines, Thailand, and Vietnam. It will focus on three key markers of good quality care for patients with a hip fracture: 1. Reducing delays to surgery, 2. Reducing the time taken for patients to start walking after surgery and 3. speeding up general medical assessment. The study will see if hospitals that have training and support to help with multi-disciplinary care can improve patient’s quality of life compared with hospitals that continue with their usual patient care pathways.
Who can participate?
Patients at participating hospitals aged 60 years and over who are having surgery for a hip fracture
What does the study involve?
Hospitals that take part will randomly allocate participants to continue with their usual care pathways or be given additional training and support with multi-disciplinary care. Patients who consent to will receive the standard care in their hospital. They will answer a set of questions about daily life before their injury. Information about the treatment and care they receive in hospital will be taken from their medical notes. After 4 months, participants will be contacted and asked a set of questions about their daily lives, as well as some additional questions about their care and treatment expenses. Some participants may be invited to talk to a researcher with other participants in a focus group, in more detail about their injury and taking part in the study.
What are the potential benefits and risks of participating?
There are no specific risks or benefits to taking part in the study as participants will be following the treatment and care plan of their hospital. By helping us to have a better understanding of treatment and recovery after hip fracture, the service may be improved for other patients in the future.
Where is the study run from?
The University of Oxford (UK)
When is the study starting and how long is it expected to run for?
November 2022 to October 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR), Research on Interventions for Global Health Transformation
Who is the main contact?
UK central trial team: hipcare@ndorms.ox.ac.uk
Contact information
Principal Investigator
Oxford Trauma and Emergency Care
Nuffield Department of Orthopaedics
Rheumatology and Musculoskeletal Sciences
Kadoorie Centre, John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 223115 |
|---|---|
| Matthew.costa@ndorms.ox.ac.uk |
Public, Scientific
Oxford Trauma and Emergency Care
Nuffield Department of Orthopaedics
Rheumatology and Musculoskeletal Sciences
Kadoorie Centre, John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 223115 |
|---|---|
| hipcare@ndorms.ox.ac.uk |
Study information
| Study design | Multicentre interventional cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A cluster randomised controlled trial with embedded process evaluation to investigate the clinical and cost effectiveness of multidisciplinary care in the management of patients with a fracture of the hip |
| Study acronym | HIPCARE |
| Study hypothesis | To determine if quality of life for patients in low- and middle-income Countries in Asia after hip fracture can be improved with the introduction of multi-disciplinary care training and support, and whether it reduces healthcare costs, compared with usual care. |
| Ethics approval(s) |
Approved 13/07/2023, Oxford Tropical Research Ethics Committee (Research Services, Research Governance, Ethics & Assurance Boundary Brook House, Churchill Drive, Oxford, OX3 7GB, United Kingdom; +44 (0)1865 282106; oxtrec@admin.ox.ac.uk), ref: 520-23 |
| Condition | Hip fracture |
| Intervention | Hospitals will be randomised to the HIPCARE intervention or usual care, via a centralised computer-based process stratified by country and will be carried out in advance of the start of recruitment. Intervention arm: The hospitals allocated to the HIPCARE intervention will be given additional funds to allocate the time of a senior clinician to act as an Intervention Champion. The local Principal Investigator and the Intervention Champion will establish a multi-disciplinary HIPCARE Working Group. HIPCARE intervention hospitals will be provided with a multi-disciplinary training package with online support. This will be focussed on: 1. Reducing delays to surgery, 2. Reducing the time taken for patients to start walking after surgery and 3. speeding up general medical assessment. Control arm: Patients will be treated as per the pre-trial pathways for hip fracture patients. |
| Intervention type | Mixed |
| Primary outcome measure | Health-related quality of life measured using EuroQol-5D–5L at baseline and 120 days post-surgery |
| Secondary outcome measures | 1. Mortality, measured using death notification data up to 120 days post-surgery 2. Mobility, measured using the Modified New Mobility Score (mNMS) at baseline and 120 days post-surgery 3. Residential status measured using a bespoke questionnaire at baseline and 120 days post-surgery 4. Complication rate measured using medical records and a bespoke questionnaire at 120 days post-surgery 5. Healthcare and broader resource implications measured using medical records and bespoke questionnaire at baseline and 120 days post-surgery 6. Estimated cost-effectiveness of the trial treatments measured using medical records, bespoke questionnaire, and the Euroqol-5D-5L at 120 days post-surgery |
| Overall study start date | 01/11/2022 |
| Overall study end date | 31/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 9000 |
| Participant inclusion criteria | Patients aged 60 years or over having surgery for a hip fracture. |
| Participant exclusion criteria | The participant or a carer cannot complete follow-up at 120 days |
| Recruitment start date | 06/11/2024 |
| Recruitment end date | 31/10/2025 |
Locations
Countries of recruitment
- India
- Nepal
- Philippines
- Thailand
- Viet Nam
Study participating centres
Philippine General Hospital
Taft Avenue
Ermita
Manila
N/A
Philippines
Salaya
Nakhon Pathom 73170
N/A
Thailand
Sinamangal
Kathmandu
N/A
Nepal
North Tu Liem
Ha Noi
N/A
Viet Nam
Sponsor information
University/education
Research Governance, Ethics and Assurance Team (RGEA)
Research services, University of Oxford, Joint Research Office
Boundary Brook House, Churchill Drive
Headington
Oxford
OX3 7LE
England
United Kingdom
| Phone | +44 (0)1865 616480 |
|---|---|
| rgea.sponsor@admin.ox.ac.uk | |
| Website | https://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/10/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The protocol will be published before recruitment has been completed. The statistical analysis plan will be published before the final data has been collected. Main clinical results and health economic evaluation will be published in high-impact peer-reviewed journals after completion of the initial follow-up period. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the Lead Investigator (Prof Matt Costa, hipcare@ndorms.ox.ac.uk). Each request will be reviewed and decided upon on a case-by-case basis. Participants will be informed via the Participant Information Sheet (and will consent to the contents of this PIS) of the possibility of de-identified datasets being made available following appropriate requests. |
Editorial Notes
18/12/2024: The recruitment start date was changed from 01/08/2024 to 06/11/2024.
13/06/2024: Study's existence confirmed by the Oxford Tropical Research Ethics Committee.
