Speaker
Christopher B. Granger, MD
Donald F. Fortin, M.D. Distinguished Professor of Medicine
Professor of Nursing
Duke University
Neha J. Pagidipati, MD MPH
Associate Professor of Medicine,
Duke University School of Medicine
Keywords
COORDINATE-Diabetes; Cardiovascular disease; Intervention; Cluster-randomized trial; Implementation; Prescription
Key Points
- High-intensity statins, ACEi/ARBs, and SGLT2i and GLP-1RA have been shown to improve recovery and maintenance outcomes for patients with diabetes and atherosclerotic cardiovascular disease (ASCVD). However, these therapies are highly underused in routine clinical practice.
- The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies. This was a cluster-randomized trial of 42 cardiology clinics across the U.S., in which participants had type 2 diabetes mellitus and ASCVD. The cardiology clinics were randomized to one of two groups. The first group consisted of a usual care arm, where they received basic guidelines for treating diabetes or ASCVD. The second group of clinics implemented a multifaceted intervention at the provider level. The intervention included assessment of local practices and barriers, development of strategies to overcome those barriers, and audit and feedback of quality metrics, with the goal of improving the way clinics approach treatment of these diseases.
- About 6-12 months after enrollment, patients were assessed for the primary outcome, which was the prescription of all 3 recommended therapies. These therapies included an anti-hyperglycemic agent with evidence for cardiovascular benefit, ACEi/ARB/ARNI, and high-intensity statin.
- In the usual care arm sites, 14.5% of the patients ended up being prescribed all 3 therapies, and 37.9% of patients were prescribed all 3 therapies across the intervention sites. The 23.4% absolute difference highlights the important benefits of utilizing the provider education and interdisciplinary care pathway tools included in the intervention being tested in this trial.
- An important aspect of the intervention was regular phone calls and check-ins to patients prescribed the therapies to ensure they were taking the prescriptions. Results of the study showed a positive correlation between prescription of the therapies and the patients actually using the medications.
- Key study limitations were the need for remote delivery due to the COVID-19 pandemic and the lack of total representation of the broader U.S. or international population across the selected sites and patients.
- Ultimately, this trial concluded that a coordinated, multifaceted intervention increased prescription of 3 groups of evidence-based therapies in adults with T2D and ASCVD. The results of this trial highlight the under-use of evidence-based therapies in clinical practice and the lack of high-quality data on how to improve this gap. It is essential to scale this intervention across cardiology practices in order to improve the quality of care being delivered more broadly to ensure the implementation of these trial results.
Learn more
Read about the COORDINATE-Diabetes trial.
Discussion Themes
-What are the challenges of implementing the implementation intervention of this trial? What is the trade-off between simple approaches versus multi-faceted approaches? Simple approaches are scalable and less expensive, but the benefits are less impressive. In this program, we were trying to change a more complex behavior with a higher activation energy, which is not only to prescribe one therapy, but to take a very complex patient population and prescribe multiple therapies, which inherently requires more than just a prompt here or there. One of the barriers we faced was a lack of education and familiarity with the therapies, which takes more than just a prompt to overcome. In this trial, we tried to land somewhere in the middle of the trade-off between simple and multi-faceted.
-Is there a reason for the disproportionate number of participants between the usual care and intervention groups? Ideally all participants would be identified and enrolled prior to starting the trial. This was not the case for COORDINATE-Diabetes primarily due to time constraints. They randomized the clinics, then enrolled the patients. This can be a limitation of cluster-randomized trials, as the knowledge of which group they are randomized to could impact patient enrollment.
-How can you sustain this intervention across all components of the process? That might be an important jumping point for the second leg of COORDINATE-Diabetes to answer questions such as: How do you get payers and Medicare to sustain these interventions? How do you elevate the pharmacists to get embedded in the clinics and remain engaged? How do you incentivize patients to see this through?
Tags
#pctGR, @Collaboratory1