Quality Improvement Intervention and Outcomes in AMI Patients in India
What is the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in India, a rapidly developing economy?
The study investigators conducted a cluster randomized, stepped-wedge clinical trial on patients presenting with an acute myocardial infarction (AMI) between November 10, 2014, and November 9, 2016, in 63 hospitals in a southern Indian state, with a last date of follow-up of December 31, 2016. The investigators randomly selected hospitals in a one-way crossover from the control group to the intervention group during five predefined steps over the study period. The hospitals provided either usual care (control group; n = 10,066 participants [step 0: n = 2,915; step 1: n = 2,649; step 2: n = 2,251; step 3: n = 1,422; 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 = 1,265; step 3: n = 2,432; step 4: n = 3,214; step 5: n = 3,735]) that consisted of audit and feedback, checklists, patient education materials, and linkage to emergency cardiovascular care and quality improvement training. The primary outcome was the composite of all-cause mortality, re-infarction, stroke, or major bleeding using standardized definitions at 30 days. Secondary outcomes included the primary outcome’s individual components, 30-day cardiovascular mortality, medication use, and tobacco cessation counseling. The authors utilized mixed-effects logistic regression models to account for clustering and temporal trends.
The study investigators found that 21,079 (99%) among 21,374 eligible randomized participants (mean age, 60.6 [standard deviation, 12.0] years; n = 16,183 men [76%]; n = 13,689 [64%]) with ST-segment elevation MI, 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. Secondary and post hoc analyses revealed that the rate of 30-day mortality was 3.9% in the intervention group compared with 5.1% in the control group. The cluster-adjusted odds ratio for 30-day mortality was 0.87 (95% CI, 0.75-1.00), an effect that was not statistically significant after adjusting for temporal trends (adjusted risk difference, −0.28% [95% CI, −1.35% to 0.80%]; adjusted odds ratio, 0.94 [95% CI, 0.74-1.19]). These results did not materially change after adjustment for GRACE score covariates.
The study authors concluded that among patients with AMI in southern India, use of a quality improvement intervention compared with usual care did not decrease a composite of 30-day major adverse cardiovascular events. They opined that further research is needed to understand the lack of efficacy.
The authors need to be congratulated for their efforts to ascertain determinants of AMI outcomes in a highly heterogeneous health care system. This paper will be a starting point for those seeking process and quality improvements of AMI care in the heterogeneous Indian health care system.
Keywords: Acute Coronary Syndrome, Cardiology Interventions, Emergency Medical Services, Hemorrhage, Myocardial Ischemia, Process Assessment (Health Care), Outcome and Process Assessment (Health Care), Quality Improvement, Reperfusion, Secondary Prevention, Stroke, Tobacco Use Cessation
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