Collaborative Quality Improvement (C-QIP) Study

Heart Failure Clinical Trial

— C-QIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196659
• Other study ID #: RA1055
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: Public Health Foundation of India
• Contact: Kavita Singh, PhD
• Phone: 911244781400
• Email: kavita.singh[@]phfi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Heart Failure
• Ischemic Stroke
• Myocardial Ischemia

Intervention

Behavioral:
• Integrated comprehensive cardiovascular disease management
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

Locations

Country	Name	City	State
India	SDM College of Medical Sciences and Hospital	Dharwad	Karnataka
India	All India Institute of Medical Sciences (AIIMS)	New Delhi	Delhi
India	GB Pant Hospital	New Delhi
India	Sir Ganga ram Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Public Health Foundation of India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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	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).
Secondary	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).