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oai:figshare.com:article/34026759 2026-09-29T17:37:41Z category_7 category_12 category_21 category_61 category_62 category_64 portal_5 item_type_6 month_year_09_2026

<p>Statistical analysis plan.</p> Kavita Singh (182141) Ambuj Roy (2279797) Dimple Kondal (3486635) Kalyani Nikhare (13971586) Mareesha Gandral (25138404) Satish G. Patil (25138407) Kiran Aithal (12127307) Meenahalli Palleda Girish (25371907) Mohit Gupta (412345) Kushal Madan (23658814) Jitendra P. S. Sawhney (24948256) Kamar Ali (25138416) Meetushi Jain (25138419) Savitesh Kushwaha (6897110) Devraj Jindal (5612351) Emily Mendenhall (583134) Shivani A. Patel (8486277) Kabayam M. Venkat Narayan (19323374) Nikhil Tandon (126558) Mark D. Huffman (9951961) Dorairaj Prabhakaran (102287) Medicine Cell Biology Biotechnology Developmental Biology Marine Biology Cancer quality improvement strategies electronic decision support directed medical therapy confirmatory hybrid trials collaborative quality improvement strategy among patients reduce cardiovascular morbidity 12 ]), diet physician care coordination ischemic heart disease gdmt ), self qip trial demonstrated 4 %) c heart failure ischemic stroke cardiovascular diseases 81 ]), 2 %) 13 ]), usual care chronic care care processes xlink "> versus 82 versus 70 versus 32 versus 31 risk factors reported adherence private hospitals primary outcomes preliminary effect physical activity patient education multicomponent strategy message reminders median follow limited power future large establish whether clinical outcomes >; ctri 78 ]) 410 adults <div> <p>Background</p><p>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.</p> <p>Methods and findings</p><p>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.</p> <p>Conclusions</p><p>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.</p> <p>Trial Registrations</p><p><a href="https://clinicaltrials.gov/ct2/show/NCT05196659" target="_blank">NCT05196659</a>; CTRI/2022/04/041847</p></div> 2026-09-29T17:55:22Z Text Journal contribution 10.1371/journal.pmed.1004932.s004 https://figshare.com/articles/journal_contribution/_p_Statistical_analysis_plan_p_/34026759 CC BY 4.0