Collaborative Quality Improvement (C-QIP) Study

Study Overview
=================
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: 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. To assess the transferability of components of internationally successful multifaceted quality improvement strategies and chronic care models to the Indian healthcare context. 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. 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.

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

Conditions
-----------------
Coronary Heart Disease, Ischemic Stroke, Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Integrated comprehensive cardiovascular disease management


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Individual randomized parallel-group feasibility trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL Group<br>Regular current system of care Treating physicians provided current cardiovascular disease management guidelines Patients provided a leaflet (printed information) on healthy lifestyle | |
| Active Comparator: INTERVENTION Group<br>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 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 Text-message based reminders for a healthy lifestyle Patient diary containing visual assessment tool for adherence to medication (VITA) and reinforcement tool for lifestyle modification Quarterly audit and feedback to the clinical team | Behavioral: Integrated comprehensive cardiovascular disease management<br>* 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 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 Text-message based reminders for a healthy lifestyle Patient diary containing visual assessment tool for adherence to medication (VITA) and reinforcement tool for lifestyle modification Quarterly audit and feedback to the clinical team<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation outcomes | 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. | at the end of study (maximum follow-up duration 24 months). | 
| Prescription of evidence based medicines | 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. | at the end of study (maximum follow-up duration 24 months). | 
| Adherence to prescribed therapy | 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. | at the end of study (maximum follow-up duration 24 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Mean change in systolic and diastolic blood pressure between the intervention and control group participants at the trial end. | at the end of study (maximum follow-up duration 24 months). | 
| Change in low density lipoprotein cholesterol (LDLc) | Mean change in LDLc between the intervention and control group participants at the trial end. | at the end of study (maximum follow-up duration 24 months). |