Collaborative Quality Improvement (C-QIP) Study
- Conditions
- Heart FailureCoronary Heart DiseaseIschemic Stroke
- Interventions
- Behavioral: Integrated comprehensive cardiovascular disease management
- Registration Number
- NCT05196659
- Lead Sponsor
- Public Health Foundation of India
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
Participants should be:
- age ≥18 years, both sexes
- confirmed diagnosis of cardiovascular disease (ischemic heart disease, stroke, or heart failure irrespective of ejection fraction)
- able to provide written informed consent.
- pregnant women
- those with any serious or uncontrolled medical condition (e.g., cancer) that may restrict the patient to come for follow-up.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INTERVENTION Group 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
- Primary Outcome Measures
Name Time Method Prescription of evidence based medicines at the end of study (maximum follow-up duration 24 months). Through patient chart review, the study will assess the proportion of intervention arm versus control group participant's receiving evidence based medicines for cardiovascular disease management.
Implementation outcomes at the end of study (maximum follow-up duration 24 months). Using mixed methods evaluation involving quantitative survey and in-depth interviews with the providers and patients, the primary outcome of this study is to assess the implementation outcomes such as the feasibility, and acceptability of the trial intervention defined as the extent to which providers and patients perceive the intervention strategy to be feasible to implement and useful/acceptable in their local health care setting.
Adherence to prescribed therapy at the end of study (maximum follow-up duration 24 months). Using validated questionnaire for medication adherence, the study will assess patient's compliance or adherence to prescribed therapy in the intervention group versus control group participants at the trial end.
- Secondary Outcome Measures
Name Time Method Change in low density lipoprotein cholesterol (LDLc) at the end of study (maximum follow-up duration 24 months). Mean change in LDLc between the intervention and control group participants at the trial end.
Change in blood pressure at the end of study (maximum follow-up duration 24 months). Mean change in systolic and diastolic blood pressure between the intervention and control group participants at the trial end.
Trial Locations
- Locations (4)
Sir Ganga ram Hospital
🇮🇳New Delhi, India
GB Pant Hospital
🇮🇳New Delhi, India
All India Institute of Medical Sciences (AIIMS)
🇮🇳New Delhi, Delhi, India
SDM College of Medical Sciences and Hospital
🇮🇳Dharwad, Karnataka, India