Clinical trial NCT05196659: Collaborative Quality Improvement (C-QIP) Study
Official title: Developing and Testing a Collaborative Quality ImProvement (C-QIP) Initiative for Prevention of Cardiovascular Disease in India
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Ischemic Stroke
Heart Failure
Lead sponsor: Public Health Foundation of India
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual randomized parallel-group feasibility trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Implementation outcomes
timeFrame: at the end of study (maximum follow-up duration 24 months).
measure: Prescription of evidence based medicines
timeFrame: at the end of study (maximum follow-up duration 24 months).
measure: Adherence to prescribed therapy
timeFrame: at the end of study (maximum follow-up duration 24 months).
Secondary outcomes:
measure: Change in blood pressure
timeFrame: at the end of study (maximum follow-up duration 24 months).
measure: Change in low density lipoprotein cholesterol (LDLc)
timeFrame: at the end of study (maximum follow-up duration 24 months).
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS)
state: Delhi
city: Dharwad
country: India
facility: SDM College of Medical Sciences and Hospital
state: Karnataka
city: New Delhi
country: India
facility: GB Pant Hospital
city: New Delhi
country: India
facility: Sir Ganga ram Hospital
Study officials:
affiliation: Public Health Foundation of India
name: Kavita Singh, PhD
role: PRINCIPAL_INVESTIGATOR
References: