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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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