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Randomized Controlled Trial
. 2018 Feb 13;319(6):567-578.
doi: 10.1001/jama.2017.21906.

Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial

Mark D Huffman  1 , Padinhare P Mohanan  2 , Raji Devarajan  3   4 , Abigail S Baldridge  1 , Dimple Kondal  3   4 , Lihui Zhao  3   4 , Mumtaj Ali  3   4 , Mangalath N Krishnan  5 , Syam Natesan  6 , Rajesh Gopinath  7 , Sunitha Viswanathan  8 , Joseph Stigi  9 , Johny Joseph  10 , Somanathan Chozhakkat  11 , Donald M Lloyd-Jones  1 , Dorairaj Prabhakaran  3   4   12 ; Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Investigators
Affiliations
Randomized Controlled Trial

Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial

Mark D Huffman et al. JAMA. .

Abstract

Importance: Wide heterogeneity exists in acute myocardial infarction treatment and outcomes in India.

Objective: To 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 participants: Cluster 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.

Interventions: Hospitals 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 measures: The 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.

Results: Among 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 relevance: Among 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 registration: clinicaltrials.gov Identifier: NCT02256657.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Huffman reports receipt of support from the World Heart Federation to serve as its senior program advisor for the Emerging Leaders program, which is supported by unrestricted educational grants from Boehringer Ingelheim and Novartis with previous support from BUPA and AstraZeneca.

Figures

Figure 1.
Figure 1.. Flow of Hospitals and Participants Through the ACS QUIK Trial
All hospitals approached agreed to participate and were included. Randomization occurred at a single time point prior to patient enrollment. Hospitals were blinded to their assigned cohort until 2 weeks prior to the time point at which their cohort moved from the control stage to intervention stage. Participants lost to follow-up include those who could not be reached after 3 contact attempts and those for whom the site did not perform the follow-up procedure. Patients lost to follow-up were included in the analysis.
Figure 2.
Figure 2.. Unadjusted Temporal Trends in 30-Day Major Adverse Cardiovascular Event Rates and Mortality Rates
Open circles indicate rates during the control period; solid circles represent rates during the intervention period. Error bars indicate 95% CIs.
Figure 3.
Figure 3.. Effect of Quality Improvement Tool Kit Intervention on 30-Day Major Adverse Cardiovascular Events by Prespecified Subgroups After Adjustment for Within-Hospital Clustering and Temporal Trends
NSTEMI indicates non–ST-segment elevation myocardial infarction; STEMI, ST-segment elevation myocardial infarction. Size of the data markers indicates precision of the point estimates.
See this image and copyright information in PMC

Comment in

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