Assessing a multicomponent quality improvement strategy for chronic care of cardiovascular diseases in India: The C-QIP randomized feasibility trial

Background Chronic cardiovascular diseases (CVD) care quality remains suboptimal, globally. We assessed the feasibility, acceptability, fidelity, and preliminary effect of a multicomponent, collaborative quality improvement (C-QIP) strategy among patients with CVD attending outpatient clinics in India. Methods and findings In this pragmatic feasibility randomized controlled trial, 410 adults with ischemic heart disease, ischemic stroke, or heart failure attending four public and private hospitals were randomized to C-QIP (electronic decision support for providers, non-physician care coordination, patient education, text-message reminders, and audit-feedback) or usual care. Primary outcomes were feasibility, fidelity, adoption, and acceptability; secondary outcomes included guideline-directed medical therapy (GDMT), self-reported adherence, care processes, and risk factors. At end of study (median follow-up 15 months), retention was 192/206 (93.2%) in C-QIP and 187/204 (91.7%) in usual care. Fidelity was high: 187/198 (94.4%) C-QIP participants received lifestyle counseling at end of study. C-QIP increased GDMT use for ischemic heart disease (58.3% versus 32.4%; relative risk [RR] 1.45, 95% CI [1.18, 1.78]) and ischemic stroke (76.7% versus 31.8%; RR 2.41, 95% CI [1.52, 3.81]), but not heart failure. Self-reported adherence was higher for medications (90.9% versus 82.3%; RR 1.08, 95% CI [1.04, 1.12]), diet (91.9% versus 82.3%; RR 1.07, 95% CI [1.02, 1.13]), and physical activity (91.4% versus 70.4%; RR 1.23, 95% CI [1.16, 1.30]). Limitations include feasibility design, individual randomization within shared clinics, and limited power for clinical outcomes and subgroup analysis. Conclusions The C-QIP trial demonstrated that a multicomponent strategy is feasible, acceptable, and improved chronic CVD care processes in India. Future large, confirmatory hybrid trials are needed to establish whether such quality improvement strategies can reduce cardiovascular morbidity and mortality. Trial Registrations NCT05196659 ; CTRI/2022/04/041847