• Mark D Huffman, Padinhare P Mohanan, Raji Devarajan, Abigail S Baldridge, Dimple Kondal, Lihui Zhao, Mumtaj Ali, Mangalath N Krishnan, Syam Natesan, Rajesh Gopinath, Sunitha Viswanathan, Joseph Stigi, Johny Joseph, Somanathan Chozhakkat, Donald M Lloyd-Jones, Dorairaj Prabhakaran, and Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Investigators.
• Northwestern University Feinberg School of Medicine, Chicago, Illinois.
• JAMA. 2018 Feb 13; 319 (6): 567-578.

ImportanceWide heterogeneity exists in acute myocardial infarction treatment and outcomes in India.ObjectiveTo evaluate the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in Kerala, a southern Indian state.Design, Setting, And ParticipantsCluster randomized, stepped-wedge clinical trial conducted between November 10, 2014, and November 9, 2016, in 63 hospitals in Kerala, India, with a last date of follow-up of December 31, 2016. During 5 predefined steps over the study period, hospitals were randomly selected to move in a 1-way crossover from the control group to the intervention group. Consecutively presenting patients with acute myocardial infarction were offered participation.InterventionsHospitals provided either usual care (control group; n = 10 066 participants [step 0: n = 2915; step 1: n = 2649; step 2: n = 2251; step 3: n = 1422; step 4; n = 829; step 5: n = 0]) or care using a quality improvement tool kit (intervention group; n = 11 308 participants [step 0: n = 0; step 1: n = 662; step 2: n = 1265; step 3: n = 2432; step 4: n = 3214; step 5: n = 3735]) that consisted of audit and feedback, checklists, patient education materials, and linkage to emergency cardiovascular care and quality improvement training.Main Outcomes And MeasuresThe primary outcome was the composite of all-cause death, reinfarction, stroke, or major bleeding using standardized definitions at 30 days. Secondary outcomes included the primary outcome's individual components, 30-day cardiovascular death, medication use, and tobacco cessation counseling. Mixed-effects logistic regression models were used to account for clustering and temporal trends.ResultsAmong 21 374 eligible randomized participants (mean age, 60.6 [SD, 12.0] years; n = 16 183 men [76%] ; n = 13 689 [64%] with ST-segment elevation myocardial infarction), 21 079 (99%) completed the trial. The primary composite outcome was observed in 5.3% of the intervention participants and 6.4% of the control participants. The observed difference in 30-day major adverse cardiovascular event rates between the groups was not statistically significant after adjustment (adjusted risk difference, -0.09% [95% CI, -1.32% to 1.14%]; adjusted odds ratio, 0.98 [95% CI, 0.80-1.21]). The intervention group had a higher rate of medication use including reperfusion but no effect on tobacco cessation counseling. There were no unexpected adverse events reported.Conclusions And RelevanceAmong patients with acute myocardial infarction in Kerala, India, use of a quality improvement intervention compared with usual care did not decrease a composite of 30-day major adverse cardiovascular events. Further research is needed to understand the lack of efficacy.Trial Registrationclinicaltrials.gov Identifier: NCT02256657.

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