| CTRI Number |
CTRI/2025/07/090066 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
HIPCARE trial to assess effectiveness and cost of a care-package for managing hip fractures in older adults |
|
Scientific Title of Study
|
HIPCARE: 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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagnoor Jagnoor |
| Designation |
Head - Injury Division, Co-Director WHO Collaborating Centre on Injury Prevention and Trauma Care |
| Affiliation |
The George Institute for Global Health, India |
| Address |
The George Institute for Global Health, 308, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre
New Delhi DELHI 110025 India |
| Phone |
114158809193 |
| Fax |
|
| Email |
jjagnoor1@georgeinstitute.org.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jagnoor Jagnoor |
| Designation |
Head - Injury Division, Co-Director WHO Collaborating Centre on Injury Prevention and Trauma Care |
| Affiliation |
The George Institute for Global Health, India |
| Address |
The George Institute for Global Health, 308, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre
New Delhi DELHI 110025 India |
| Phone |
114158809193 |
| Fax |
|
| Email |
jjagnoor1@georgeinstitute.org.in |
|
Details of Contact Person Public Query
Modification(s)
|
| Name |
Ms Deepti Beri |
| Designation |
Research Fellow |
| Affiliation |
George Institute Services India Private Limited |
| Address |
George Institute Services India Private Limited, 409, Fourth Floor, Elegance Tower Plot No. 8
Jasola District Centre
New Delhi DELHI 110025 India |
| Phone |
114158809193 |
| Fax |
|
| Email |
deepti.beri@george-services.com |
|
|
Source of Monetary or Material Support
|
| National Institute for Health and Care Research (NIHR), Research and Innovation for Global Health Transformation (RIGHT) Programme Department of Health & Social Care, United Kingdom. |
|
|
Primary Sponsor
|
| Name |
University of Oxford |
| Address |
University of Oxford, Joint Research Office, 1st floor, Boundary Brook House Churchill Drive, Headington, OX3 7GB, Oxford, United Kingdom. |
| Type of Sponsor |
Other [Academic Institution] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India Nepal Philippines Thailand Viet Nam |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Sharma |
All India Institute of Medical Sciences, Delhi |
Department of Orthopaedics,
AIIMS Jai Prakash Narayan Apex Trauma Center, Room No. 407, 4th Floor, Ring Rd, Raj Nagar, Safdarjung Enclave, New Delhi, Delhi 110029 South DELHI |
91 9899502492
drvijaysharmatrauma@gmail.com |
| Dr Harpal Singh Selhi |
Dayanand Medical College, Ludhiana |
Department of Orthopaedics, Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001 Ludhiana PUNJAB |
91 9815022527
drharpal@gmail.com |
| Dr Pradip Nemade |
King Edward Memorial Hospital, Mumbai |
6th Floor MSB, Acharya Donde Marg, Parel East, Parel, Mumbai, Maharashtra 400012 Mumbai MAHARASHTRA |
91 9819936959
pradipnemade@gmail.com |
| Dr Srinivas Kasha |
Krishna Institute of Medical Sciences, Secunderabad |
Department of Orthopaedic Surgery, 1-8-31/1, Minister Rd, Krishna Nagar Colony, Ramgopalpet, Secunderabad, Hyderabad, Telangana 500003 Hyderabad TELANGANA |
91 9948699946
drsrinivaskasha@gmail.com |
| Dr Sameer Aggarwal |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Room No. 15, Block B, Nehru Hospital, Madhya Marg, Sector 12, Chandigarh, 160012 Chandigarh CHANDIGARH |
91 7087009748
drsameer35@yahoo.co.in |
| Dr Avtar Balawat |
Sawai Man Singh Medical College, Jaipur |
Department of Orthopaedics, New SMS Campus Rd, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004 Jaipur RAJASTHAN |
91 7727049356
dravtar01@gmail.com |
| Dr Tahir Ahmad Dar |
Sher-i-Kashmir Institute of Medical Sciences, Srinagar |
Department of Orthopaedics, SKIMS Main Rd, Soura, Srinagar, Jammu and Kashmir 190011 Srinagar JAMMU & KASHMIR |
91 9419018248
tahir217@gmail.com |
| Dr Joe Cherian |
St. Johns Medical College Hospital, Bangalore |
Department of Orthopaedics, 193, 1, Hosur Rd, Santhosapuram, Koramangala Industrial Layout, Koramangala, Bengaluru, Karnataka 560034 Bangalore KARNATAKA |
91 9343794300
cherianjoe71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee, Sawai Man Singh Medical College and Attached Hospitals, Jaipur |
Submittted/Under Review |
| IEC SKIMS, Sher-i-Kashmir Institute of Medical Sciences, Soura, Srinagar, Jammu and Kashmir |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Dayanand Medical College and Hospital Ludhiana |
Approved |
| Institutional Ethics Committee for Biomedical and Health Research, Post Graduate Institute of Medical Education and Research, Chandigarh |
Submittted/Under Review |
| Institutional Ethics Committee, St. Johns Medical College, Bangalore, Bengaluru |
Submittted/Under Review |
| Institutional Ethics Committee-1 Seth GS Medical College and KEM Hospital Mumbai |
Submittted/Under Review |
| KIMS Institutional Ethics Committee, Krishna Institute of Medical Sciences Limited Secunderabad |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S789||Traumatic amputation of hip and thigh, level unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HIPCARE INTERVENTION package |
Intervention HIPCARE INTERVENTION package Hospitals in the intervention group will receive support on how to improve the current care pathway for hip fractures. Hospitals receiving intervention will be provided with a multi-disciplinary intervention training package with online support, which will assist in describing the current service availability and readiness for hip fracture care in the centre and other centres. These hospitals will use evidence-based package, tailored accordingly to their hospital system. As the multidisciplinary package has three elements, the target duration of each one is specified below. The outcome will be measured after 120 days post-surgery. 1. Reduced time to surgery from admission to hospital – target: surgery 36 hours. 2. Rapid mobilisation post-surgery – target: patient mobilised with unrestricted weight-bearing 24h after surgery. 3. Prompt review by a senior physician with an interest in older patients, to include a review of co-morbidity, medication, delirium screening, bone health assessment and falls assessment – target: review 72h of admission. |
| Comparator Agent |
Usual care |
Patients will be treated as per the pre-trial pathways for hip fracture patients and quality of life status and other secondary outcome measures will be evaluated 120 days post surgery. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 60 years or over, having surgery for a hip fracture. |
|
| ExclusionCriteria |
| Details |
The participant will not enter the study if they, or a carer are unlikely to be available for follow-up at 120 days, e.g. foreign national returning to another country. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health-related quality of life (by EuroQol EQ-5D-5L13 index) at 120 days post-surgery. |
Health-related quality of life (by EuroQol EQ-5D-5L13 index) at 120 days post-surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of mortality between the treatment groups in the first 120 days post-surgery |
120 days post-surgery |
| Comparison of mobility between the treatment groups at 120 days post-surgery, using Modified New Mobility Score |
Baseline, 120 days post-surgery
|
| Comparison of the proportion of participants who have returned to their pre-fracture residential status by 120 days post-surgery, using Bespoke Residential Status questionnaire |
Baseline, 120 days post-surgery
|
| Comparison of complication rate within the first 120 days post-surgery, using Medical records and bespoke participant questionnaire |
120 days post-surgery |
| Comparison of healthcare and broader resource implications within the first 120 days post-surgery. |
Baseline, 120 days post-surgery
|
| Estimation of cost-effectiveness of the trial treatments |
120 days post-surgery |
|
|
Target Sample Size
|
Total Sample Size="9000" Sample Size from India="1800"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| Hip fractures are the most common type of fractures among the elderly and are associated with high mortality and poor quality of life. The outcomes of hip fractures are poorer in low-and-middle income countries (LMICs) compared to high-income countries (HIC) due to lack of healthcare resources. With introduction of multidisciplinary care package for treating patients of hip fractures, HICs have showed reduction in burden of hip fractures. This package brings together different healthcare professionals with defined roles to work collectively as a team for providing timely, adequate, and quality treatment for managing hip fracture patients. This includes early surgery to fix the hip fracture, health assessment by specialists and early walking with help of help of a healthcare worker. With limited resources and weak medical systems in LMICs like India, introducing such multidisciplinary packages can play a significant role in bringing down the rapidly increasing burden of hip fractures. From India, eight sites will be recruited to test this package, where half the hospitals will have the HIPCARE intervention and half continue with their usual care. Patients from ’usual care’ and ‘HIPCARE’ hospitals will be asked to report their health-related quality of life before their injury and again 4 months after. Information about cost of the treatment and any care they receive in the 4 months after their injury will also be collected. Through this study, we aim to test such a package (HIPCARE package) in five LMICs, including India. The study will test if there will be a difference between quality of life (primary outcome), number of deaths, other health related problems and complications and percentage of patients returning home after hospitalisation, who will receive this package and those will be receive usual care given in hospitals. We will also compare overall resource implications and cost effectiveness of both care pathways for management of hip fractures in elderly. We also aim to conduct a ‘process evaluation’ using a collection of both quantitative and qualitative data to assess the success/failure of the package, its perceived impact, and possibility of adopting such a package for treating and caring for old people with hip fracture. This will include speaking with senior doctors, administrators, managers, members of the multidisciplinary team, patients and their carers. | |