Collaborative Quality Improvement (C-QIP) Study

Public Health Foundation of India

Status: Completed

Conditions: Ischemic Stroke; Coronary Heart Disease; Heart Failure

Treatments: Behavioral: Integrated comprehensive cardiovascular disease management

Study type: Interventional

Funder types: Other

Identifiers

NCT05196659

RA1055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 410 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• pregnant women
• those with any serious or uncontrolled medical condition (e.g., cancer) that may restrict the patient to come for follow-up.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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410 participants in 2 patient groups

CONTROL Group

No Intervention group

Description:

* Regular current system of care * Treating physicians provided current cardiovascular disease management guidelines * Patients provided a leaflet (printed information) on healthy lifestyle

INTERVENTION Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Integrated comprehensive cardiovascular disease management