Mark D. Huffman
A quality improvement intervention did not decrease 30-day major adverse CV events when compared with the usual care in patients with acute MI in India, according to the ACS QUIK study published in JAMA.
“In 2015, there were an estimated 7.3 million fatal myocardial infarctions globally, and South Asia was estimated to have the world’s highest age-standardized incident rate of myocardial infarction,” Mark D. Huffman, MD, MPH, associate professor of preventive medicine and medicine-cardiology at Northwestern University Feinberg School of Medicine, and colleagues wrote. “High-income countries have developed programs for improving process and outcomes measures for acute myocardial infarction that have been associated with improvements in care and outcomes with concomitant reductions in racial/ethical disparities in care.”
To evaluate the efficacy of a locally adapted quality improvement tool kit on clinical outcomes and process measures, researchers conducted a cluster-randomized, stepped-wedge clinical trial consisting of 21,374 patients (mean age, 61 years; 76% men) with acute MI, conducted in 63 hospitals in Kerala, India.
The results were previously presented at the American Heart Association Scientific Sessions in November.
Hospitals provided either usual care (control group; n=10,066) or care using a quality improvement tool kit (intervention group; n=11,308), consisting of audit and feedback, checklists, patient education materials, and linkage to emergency CV care and quality improvement training.
No difference in outcomes
The primary outcome was a 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 CV death, medication use and tobacco cessation counseling.
Researchers observed the primary composite outcome in 5.3% of the intervention participants and 6.4% of the control participants.
There was no statistical significance in the observed difference in 30-day major adverse CV event rates between the two groups after adjustment (adjusted risk difference = 0.09%; 95% CI, 1.32 to 1.14; aOR = 0.98; 95% CI, 0.8-1.21).
Huffman and colleagues found a higher rate of medication use among the intervention group, including reperfusion, but the groups were similar in use of tobacco cessation counseling.
There were no unexpected adverse events reported.
According to an accompanying editorial from Christopher B. Granger, MD, of Duke Clinical Research Institute, and Denis Xavier, MD, of St. John’s Medical College and Research Institute in Bangalore, India, the research represents a “state-of-the-art” attempt to inform health care professionals and health care centers how to improve care in India.
Christopher B. Granger
“There are lessons to be learned, but none is more important than demonstrating that this type of high-quality trial can be performed in middle-income countries,” they wrote. “Especially in these settings, no research to improve health care is more important that this type of implementation trial.” – by Dave Quaile
Disclosures: The authors report no relevant financial disclosures. Granger reports he receives grant funding from the Medtronic Foundation. Xavier reports he receives grants from AstraZeneca India, Boehringer Ingelheim, Bristol-Myers Squibb, Cadila Pharmaceuticals, NHLBI, Pfizer, Sanofi-Aventis and United Health.