A Randomized Feasibility Trial of a Multicomponent Quality Improvement Strategy for Chronic Care of Cardiovascular Diseases: Findings from the C-QIP Trial in India

Background: Chronic cardiovascular diseases (CVD) care quality remains suboptimal, globally. This study evaluated the feasibility and preliminary effect of a multicomponent, collaborative quality improvement (C-QIP) strategy among patients with CVD attending outpatient clinics in India. Methods and Findings: We conducted a pragmatic feasibility randomized controlled trial in patients with ischemic heart disease, ischemic stroke or heart failure across public and private hospitals in India. Participants were individually randomized to C-QIP strategy (electronic decision support system, eDSS for providers, task-sharing with non-physician health workers, patient education, and SMS text reminders, and audit-feedback) or usual care. The primary outcomes were implementation measures: feasibility, fidelity, adoption, and acceptability from provider's and patient's perspectives. Secondary outcomes included prescription of guideline-directed medical therapy (GDMT), adherence to prescribed therapy, processes of care, and CVD risk factors. Of 410 participants enrolled (intervention arm=206 and usual care arm=204), mean age was 57.5 years, and 73.0% were male. Prior history of coronary heart disease was 74.6%, ischemic stroke: 18.5%, and heart failure: 18.0%. At trial end (mean follow-up 18 months), implementation outcomes were strong: retention at end-of-study was 192/206 (93.2%) in C-QIP and 187/204 (91.7%) in usual care arm; fidelity of the intervention remained high, e.g., 187/198 (94.4%) patients received lifestyle advice at end-of-study. Clinician adoption of eDSS prompts was high, and acceptance of DSS prompts varied by type of prompts, and both patients and providers reported high acceptability at trial end. GDMT use improved significantly in C-QIP vs usual care arm at end-of-study: in patients with ischemic heart disease use of antiplatelet + statin + ACEi/ARB + beta-blocker was 58.3% vs 32.4%, RR=1.45 (95%CI: 1.18-1.78); and among patients with ischemic stroke use of antiplatelet + statin + ACEi/ARB or diuretic was 76.7% vs 31.8%, RR=2.41 (95%CI: 1.52-3.81). GDMT among patients with heart failure were not different between groups (e.g., ACEi/ARB/ARNI + beta-blocker + MRA, 48.9% vs 48.6%, RR=1.26, 95%CI: 0.82-1.94). Patient adherence to prescribed therapy improved in C-QIP vs usual care arm: medications 90.9% vs 82.3%, RR 1.08 (1.04-1.12); diet plan 91.9% vs 82.3%, RR 1.07 (1.02-1.13); and physical activity 91.4% vs 70.4%, RR=1.23 (95%CI: 1.16-1.30). Processes of care improved significantly in C-QIP vs usual care arm, including more structured reminders (e.g., call after missed appointment 70.7% vs 4.4%, p<0.001) and longer clinician contact time (median 10 vs 7 minutes, p<0.001). CVD risk factors showed small, non-significant trends (e.g., modest diastolic BP reduction) for between-group differences in blood pressure, lipids and glycemia. Conclusions: The C-QIP trial demonstrated that a multicomponent strategy is feasible, acceptable, and improved processes of chronic CVD care in India. Future large, confirmatory hybrid trials are needed to establish whether such quality improvement strategies can reduce cardiovascular morbidity and mortality. Trial Registration: Clinicaltrials.gov number: NCT05196659Clinical Trials Registry India: CTRI/2022/04/041847.