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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
410
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
SDM College of Medical Sciences and Hospital
Dharwad, Karnataka, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
GB Pant Hospital
New Delhi, New Delhi, India
Sir Ganga ram Hospital
New Delhi, New Delhi, India
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.
Time frame: 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.
Time frame: 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.
Time frame: at the end of study (maximum follow-up duration 24 months).
Change in blood pressure
Mean change in systolic and diastolic blood pressure between the intervention and control group participants at the trial end.
Time frame: 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.
Time frame: at the end of study (maximum follow-up duration 24 months).
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