NCT05196659

Collaborative Quality Improvement (C-QIP) Study

Developing and Testing a Collaborative Quality ImProvement (C-QIP) Initiative for Prevention of Cardiovascular Disease in India

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (actual)
• Sponsor: Public Health Foundation of India · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overarching goal of this study is to develop, implement, and evaluate the effect of a collaborative quality improvement (C-QIP) intervention (consisting of non-physician health workers, text messages for a healthy lifestyle, and a clinical decision support system) on processes of care and clinical outcomes among individuals with previous cardiovascular disease in India.

Detailed description

Specific objectives of this study are: 1. To describe current practices, context, challenges, and opportunities regarding chronic management of cardiovascular disease from the patient, caregiver, provider, and health administrator perspectives in India. 2. To assess the transferability of components of internationally successful multifaceted quality improvement strategies and chronic care models to the Indian healthcare context. 3. To conduct a pilot study to assess the acceptability, feasibility, and implementation fidelity of the C-QIP strategy among individuals with cardiovascular disease attending out-patient clinics in India. 4. Among individuals with cardiovascular disease, evaluate the effect of C-QIP strategy on processes of care and clinical outcomes, health-related quality of life, and costs at 1 year compared with usual care.

Conditions

• Coronary Heart Disease
• Ischemic Stroke
• Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	Integrated comprehensive cardiovascular disease management	1. Electronic Health Record-Decision Support Software (EHR-DSS): * Electronic patient health record storage * Management prompts to the clinical team (following algorithms) * Structured follow-up schedule with automatic reminders to patients, clinical team, and non-physician health worker 2. Non-physician health worker-led continuity of care: \- individually tailored follow-up and guidance regarding treatment adherence as well as help in resolving issues related to access, convenience, cost of care, and equity 3. Text-message based reminders for a healthy lifestyle 4. Patient diary containing visual assessment tool for adherence to medication (VITA) and reinforcement tool for lifestyle modification 5. Quarterly audit and feedback to the clinical team

Timeline

• Start date: 2022-09-09
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2022-01-19
• Last updated: 2026-01-21

Locations

4 sites across 1 country: India