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Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes
Evidence-based therapies to reduce atherosclerotic cardiovascular disease risk in adults with type 2 diabetes are underused in clinical practice.
To 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 PARTICIPANTS
Cluster 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.
Assessing 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 MEASURES
The 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).
Of 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 RELEVANCE
A coordinated, multifaceted intervention increased prescription of 3 groups of evidence-based therapies in adults with type 2 diabetes and atherosclerotic cardiovascular disease.
Disclosure statements are available on the authors' profiles:
Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical TrialJAMA 2023 Mar 06;[EPub Ahead of Print], NJ Pagidipati, AJ Nelson, LA Kaltenbach, M Leyva, DK McGuire, R Pop-Busui, MA Cavender, VR Aroda, ML Magwire, CR Richardson, I Lingvay, JK Kirk, HR Al-Khalidi, L Webb, T Gaynor, J Pak, C Senyucel, RD Lopes, JB Green, CB Granger
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Despite detailed, evidence-based guidelines, there are wide gaps in optimal care across the cardiometabolic spectrum. The current healthcare system has failed to deliver life-prolonging therapy to millions of Americans, with the burden heaviest in populations of color, rural areas, and other traditionally under-treated groups. Two recent studies highlight the successes and persistent challenges in redesigning care pathways to enhance guideline-directed care.
The COORDINATE–Diabetes trial was a cluster randomized study performed in 43 cardiology clinics that evaluated the effect of a coordinated, multifaceted intervention of assessment, education, and feedback to local providers versus usual care in patients with diabetes and atherosclerotic cardiovascular disease. This intense provider and patient-focused intervention improved the utilization of three classes of therapies (ACE/ARBs, statins, and SGLT2 inhibitors/GLP1RAs) by 37.9% versus 14.5% in the usual care arm, with the most significant improvement seen in the increased utilization of SGLT2 inhibitors and GLP1RAs. The major question is if this clinic-by-clinic intervention can be scaled and if it will result in sustained improvement in care.
Electronic health record (EHR) alerts, or best practice advisories, are low-cost interventions aimed at nudging individual providers to practice differently. BETTER CARE-HF was a three-armed cluster randomized trial that compared the effectiveness of 1) an alert during an individual patient encounter versus 2) a message about multiple patients between encounters versus 3) usual care in prescribing mineralocorticoid receptor antagonist (MRAs) in 2211 patients with heart failure and reduced ejection fraction (HFrEF). New MRA prescriptions occurred in 29.6% of patients in the alert arm, 15.6% in the message arm, and 11.7% in the control arm, suggesting that real-time individual notifications are most effective.
Improving care nationwide will require multimodal interventions and continued investigation to optimize the best and most cost-effective practices. Both of these studies identified different methodologies to improve care, but more than 60% of patients still failed to receive optimal care by the end of the trial, highlighting the long road we still must travel. But implementation studies like COORDINATE-Diabetes and BETTER CARE-HF offer solutions to deliver the “last mile” of care.
Medical therapy directed by current guidelines recommends that patients with type 2 diabetes should be prescribed ACE inhibitors or ARBs, high-intensity statins, and either SGLT2 inhibitors or GLP-1 receptor agonists. Despite the clear evidence that these medications are effective in reducing the risk of CVD, CKD, and death in patients with type 2 diabetes, many physicians, especially cardiologists, do not follow the guidelines in prescribing these medications to their patients. As a result, many patients receive only one or two of these medications — generally just statins and/or ACE inhibitors or ARBs — and not many get SGLT2 inhibitors or GLP-1 receptor agonists. Only a small minority receive all three therapies. This is a major problem, as it puts these patients at increased risk of heart attack, heart failure, CKD, stroke, and death. There are several reasons why physicians do not prescribe these medications. Primarily, some physicians may lack education about the latest evidence, while others may be concerned about the cost of the medications. Still others may simply be reluctant to prescribe multiple medications to their patients. Often, the patients’ reluctance to take multiple medications contributes to the problem.
The study by Pagidipati et al titled "Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical Trial" in 43 clinics across the United States provides important evidence on the effectiveness of a team-based approach and the value of education in a coordinated care intervention to improve the prescription of evidence-based therapies in adults with type 2 diabetes and atherosclerotic CVD. As a result, those in the intervention group were more likely to be prescribed all three therapies (173/457 [37.9%]) than the usual care group (85/588 [14.5%]), a difference of 23.4% (P < .001). Most impressive was the increase in cardiologists prescribing SGLT2 inhibitors or GLP-1 receptor agonists from 12.3% to 60.4% for the intervention group and only from 14.5% to 35.5% for the usual care group. Although the study showed some improvement in prescribing high-intensity statins to 70% in the intervention group, it was still less than 60% in the usual care group, leaving many patients without these important medications. This highlights the continued reluctance of some cardiologists to provide intensive control to people with diabetes.
The study's findings suggest that this type of intervention could be valuable and could be implemented in a variety of settings, making it a feasible option for many healthcare systems to improve the cardiovascular health of people with diabetes. It reinforces the potential of education and interdisciplinary team–based care approaches in modifying physicians' practice habits for the benefit of patient care and outcomes.