跳至主要内容
临床试验/CTRI/2025/07/090066
CTRI/2025/07/090066尚未招募3 期

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

University of Oxford8 个研究点 分布在 1 个国家目标入组 9,000 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
9,000
试验地点
8
主要终点
Health-related quality of life (by EuroQol EQ-5D-5L13 index) at 120 days post-surgery.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 60 years or over, having surgery for a hip fracture.

排除标准

  • 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.

结局指标

主要结局

Health-related quality of life (by EuroQol EQ-5D-5L13 index) at 120 days post-surgery.

时间窗: Health-related quality of life (by EuroQol EQ-5D-5L13 index) at 120 days post-surgery.

次要结局

  • 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)

研究者

申办方类型
Other [Academic Institution]
责任方
Principal Investigator
主要研究者

Dr Jagnoor Jagnoor

The George Institute for Global Health, India

研究点 (8)

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