Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes

Abstract

ImportanceEvidence-based therapies to reduce atherosclerotic cardiovascular disease risk in adults with type 2 diabetes are underused in clinical practice.ObjectiveTo assess the effect of a coordinated, multifaceted intervention of assessment, education, and feedback vs usual care on the proportion of adults with type 2 diabetes and atherosclerotic cardiovascular disease prescribed all 3 groups of recommended, evidence-based therapies (high-intensity statins, angiotensin-converting enzyme inhibitors [ACEIs] or angiotensin receptor blockers [ARBs], and sodium-glucose cotransporter 2 [SGLT2] inhibitors and/or glucagon-like peptide 1 receptor agonists [GLP-1RAs]).Design, Setting, and ParticipantsCluster randomized clinical trial with 43 US cardiology clinics recruiting participants from July 2019 through May 2022 and follow-up through December 2022. The participants were adults with type 2 diabetes and atherosclerotic cardiovascular disease not already taking all 3 groups of evidence-based therapies.InterventionsAssessing local barriers, developing care pathways, coordinating care, educating clinicians, reporting data back to the clinics, and providing tools for participants (n = 459) vs usual care per practice guidelines (n = 590).Main Outcomes and MeasuresThe primary outcome was the proportion of participants prescribed all 3 groups of recommended therapies at 6 to 12 months after enrollment. The secondary outcomes included changes in atherosclerotic cardiovascular disease risk factors and a composite outcome of all-cause death or hospitalization for myocardial infarction, stroke, decompensated heart failure, or urgent revascularization (the trial was not powered to show these differences).ResultsOf 1049 participants enrolled (459 at 20 intervention clinics and 590 at 23 usual care clinics), the median age was 70 years and there were 338 women (32.2%), 173 Black participants (16.5%), and 90 Hispanic participants (8.6%). At the last follow-up visit (12 months for 97.3% of participants), those in the intervention group were more likely to be prescribed all 3 therapies (173/457 [37.9%]) vs the usual care group (85/588 [14.5%]), which is a difference of 23.4% (adjusted odds ratio [OR], 4.38 [95% CI, 2.49 to 7.71]; P < .001) and were more likely to be prescribed each of the 3 therapies (change from baseline in high-intensity statins from 66.5% to 70.7% for intervention vs from 58.2% to 56.8% for usual care [adjusted OR, 1.73; 95% CI, 1.06-2.83]; ACEIs or ARBs: from 75.1% to 81.4% for intervention vs from 69.6% to 68.4% for usual care [adjusted OR, 1.82; 95% CI, 1.14-2.91]; SGLT2 inhibitors and/or GLP-1RAs: from 12.3% to 60.4% for intervention vs from 14.5% to 35.5% for usual care [adjusted OR, 3.11; 95% CI, 2.08-4.64]). The intervention was not associated with changes in atherosclerotic cardiovascular disease risk factors. The composite secondary outcome occurred in 23 of 457 participants (5%) in the intervention group vs 40 of 588 participants (6.8%) in the usual care group (adjusted hazard ratio, 0.79 [95% CI, 0.46 to 1.33]).Conclusions and RelevanceA coordinated, multifaceted intervention increased prescription of 3 groups of evidence-based therapies in adults with type 2 diabetes and atherosclerotic cardiovascular disease.Trial RegistrationClinicalTrials.gov Identifier: NCT03936660

Coordinated Care for Optimization of Cardiovascular Preventive Therapies in Patients With Diabetes—Reply

“…In fact, the best method to determine the effect of a specific treatment on outcomes is through traditional large, randomized trials, whereas the best method to determine the effect of implementation interventions is to assess the effect on application of treatments that are already well established to improve clinical outcomes. Nevertheless, the point estimate of a 21% relative risk reduction in clinical events observed in our trial was consistent with what we would have expected from large, randomized trials of these agents …”

“…In Reply The Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes (COORDINATE)–Diabetes trial was designed and powered to assess the effect of a multicomponent intervention on evidence-based medication prescription among patients with diabetes and atherosclerotic vascular disease, rather than on levels for risk factors or hard clinical outcomes. Because we did not mandate follow-up assessment of risk factors such as cholesterol or glycemic measurements, and because this trial was conducted during the height of the COVID-19 pandemic, only a minority of patients received these follow-up assessments.…”

Coordinated Care for Optimization of Cardiovascular Preventive Therapies in Patients With Diabetes

“…To the Editor We have several concerns about the recent randomized clinical trial of a coordinated intervention to increase the prescription of evidence-based therapies in adults with type 2 diabetes and atherosclerotic cardiovascular disease.…”

“…First, this cluster randomized clinical trial included a total of 1049 participants across 43 US cardiology clinics, and the clinics were randomized rather than the participants. Due to the variations in baseline patient characteristics across sites, there were more patients with atrial fibrillation in the usual care group (24.6%) compared with the intervention group (16.3%).…”

“…Third, we would like to know if adults with statin-associated adverse effects, such as myalgias, should have been excluded from this study …”