Coronary Heart Disease, Heart Failure, Ischemic Stroke
Conditions
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.
Interventions
BEHAVIORALIntegrated 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
Sponsors
Public Health Foundation of India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Individual randomized parallel-group feasibility trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORKavita Singh, PhD
Public Health Foundation of India
Outcome results
None listed