Chronic care quality for cardiovascular disease (CVD) remains suboptimal worldwide, and outpatient services in India are frequently fragmented. This trial tested whether a multicomponent collaborative quality-improvement approach could be implemented in routine outpatient clinics and improve care processes for adults with ischemic heart disease, ischemic stroke, or heart failure.
This was a pragmatic randomized feasibility trial conducted at four public and private hospitals in India. A total of 410 adults with one of the target CVD diagnoses were randomized to either the multicomponent intervention (C-QIP) or usual care. The reported median follow-up was 15 months. The study focused on feasibility, fidelity, adoption, and acceptability as primary outcomes, and examined preliminary effects on clinical care processes and self-reported behaviors as secondary outcomes.
Participants were adults with ischemic heart disease, ischemic stroke, or heart failure attending outpatient clinics at the participating hospitals. The trial enrolled 410 participants who were randomized approximately evenly between the C-QIP and usual care arms. Retention at study end was high: 192/206 (93.2%) in the C-QIP arm and 187/204 (91.7%) in the usual care arm.
The multicomponent C-QIP strategy included the following elements:
Fidelity reporting indicates that the intervention was delivered as intended in most cases; specifically, 187/198 (94.4%) C-QIP participants received lifestyle counseling by the end of the study.
Primary outcomes were implementation-focused: feasibility, fidelity, adoption, and acceptability of the C-QIP strategy within routine outpatient clinics. Secondary outcomes included use of guideline-directed medical therapy (GDMT), self-reported adherence to medicines, diet and physical activity, care processes, and risk-factor metrics. Data sources included clinic records, intervention logs, and participant self-report. The trial was registered at NCT05196659 and CTRI/2022/04/041847.
The trial demonstrated feasibility in the chosen outpatient settings. Retention through the study period was above 90% in both arms. Fidelity to core intervention components was high; for example, nearly all C-QIP participants received lifestyle counseling. Patient and provider reports indicated acceptability and willingness to continue using elements of the C-QIP strategy.
C-QIP improved use of recommended combinations of preventive medicines in two diagnostic groups:
No meaningful improvement in GDMT was reported for participants with heart failure within this feasibility trial.
Self-reported adherence also favored C-QIP across several behaviors:
These outcomes indicate the intervention improved several care processes and self-reported preventive behaviors in this cohort.
The trial reported improvements in care process metrics tied to the intervention package. Detailed risk-factor control outcomes and hard clinical endpoints (such as rates of myocardial infarction, stroke recurrence, or mortality) were not the focus of this feasibility study and the trial was not powered to detect differences in such clinical outcomes. The study provides preliminary data to inform larger trials.
Key limitations reported by the authors include the feasibility design and associated limitations in statistical power for clinical endpoints and subgroup analyses. Individual randomization occurred within shared clinics, which raises the possibility of contamination between treatment arms. These factors restrict interpretation of efficacy for hard clinical outcomes and generalizability of some subgroup findings.
The C-QIP randomized feasibility trial demonstrated that a multicomponent quality-improvement strategy is implementable, acceptable to stakeholders, and achieved high fidelity in routine outpatient clinics in India. The intervention improved guideline-directed medical therapy for ischemic heart disease and ischemic stroke, and increased self-reported adherence to medicines, diet, and physical activity. The authors recommend larger, confirmatory hybrid trials—preferably with cluster-randomized designs—to reduce contamination and to determine whether such strategies can reduce cardiovascular morbidity and mortality at scale.
The trial registrations are NCT05196659 and CTRI/2022/04/041847. The analytical dataset and codes are stored in the Centre for Chronic Disease Control (CCDC) repository and full participant-level data are restricted due to ethical and confidentiality considerations; deidentified data and/or codes may be made available on reasonable request subject to applicable requirements. The analysis code is publicly available on GitHub and archived on Zenodo as reported by the authors. Funding was provided by the Fogarty International Center, National Institutes of Health, and listed NIH awards. Competing interests disclosed include certain senior authors’ relationships and intellectual property related to clinical decision support or therapeutic development; other authors reported no competing interests.