A simple toolkit of checklists, education materials and quality and performance reporting improved the quality of care but not outcomes in hospitals in the south Indian state of Kerala and may have the potential to improve outcomes of heart attacks and other major cardiovascular disease events in other settings, according to a new Northwestern Medicine study published in the Journal of the American Medical Association (JAMA).
Previous studies had identified gaps in the quality of care in Kerala, so an international consortium, including Northwestern University and several Indian public health and professional institutions, recruited more than 21,000 patients from 63 hospitals between 2014 and 2016 to try and improve heart attack care. The Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) study represents the largest randomized trial in cardiovascular medicine in India to date, an important milestone in a country that has more heart attacks than any other.
Over the course of the study, hospitals were first assigned to deliver usual care, but were then randomly assigned to implement a quality improvement toolkit that included audit and feedback reporting, checklists, patient education materials, and linkage to emergency cardiovascular care training, which are all common strategies in the United States.
The investigators used a complex, yet useful, method known as a “stepped wedge” design, which improves investigators’ understanding of the effects of complex interventions. This method was first used in the implementation and evaluation of Gambia’s hepatitis B vaccination program in the late 1970s, yet has been rarely used because of its logistical challenges.
Over the course of the study, the investigators measured the quality of care delivered by physicians, as well as patients’ rates of major cardiovascular events including death, heart attack, stroke or major bleeding 30 days after hospital discharge.
The study found that the intervention group experienced higher rates of key in-hospital and discharge medications. The intervention group also experienced lower rates of major cardiovascular events at 30-day follow-up compared with the usual care group — 5.3 percent versus 6.4 percent — but after accounting for variables including time trends, those findings failed to reach the level of statistical significance.
While most studies would have determined that the intervention led to these differences in outcomes, the stepped wedge design used by the ACS QUIK team allowed for adjustment of important variables such as time trends.
The overall results suggest favorable trends in outcomes among heart attack patients in Kerala, which have improved over the past decade based on the team’s prior work and are similar to outcomes among U.S. heart attack patients.
“While we hoped that our trial would achieve its primary outcome, we demonstrated a high level of baseline care in Kerala. Without using the stepped wedge design, we would have incorrectly determined that our intervention was more effective than it was, which is important for setting policies to improve heart attack care,” said Dr. Mark Huffman, associate professor at Northwestern and co-first author of the study.