Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes
Author:
Pagidipati Neha J.1, Nelson Adam J.12, Kaltenbach Lisa A.1, Leyva Monica1, McGuire Darren K.34, Pop-Busui Rodica5, Cavender Matthew A.6, Aroda Vanita R.7, Magwire Melissa L.8, Richardson Caroline R.9, Lingvay Ildiko3, Kirk Julienne K.10, Al-Khalidi Hussein R.1, Webb Laura1, Gaynor Tanya11, Pak Jonathan11, Senyucel Cagri12, Lopes Renato D.1, Green Jennifer B.1, Granger Christopher B.1, Kumar Priya13, Mahal Sharan13, Javier Julian13, Purdy Drew13, Ahmed Syed13, Schmidt Dwayne13, Sharma Saurabh13, Salacata Abraham13, Covalesky John13, Paraschos Alexander13, Cohan Kenneth13, Walia Jasjit13, Ranadive Nandkishore13, Flood Roy13, Friedman Keith13, Bayron Carlos13, Weston Patrick13, Adler Alexander13, Viswanath Dilip13, Calhoun Linda13, Khandelwal Abha13, Cohen Michael13, Zarich Stuart13, Gianos Eugenia13, Korabathina Ravikiran13, Mehta Rajendra13, Hochrein James13, Arora Vikram13, Cruz Jairo13, Pacheco-Coronado Roberto13, Kelly Jacob13, Garg Rajesh13, Ogunniyi Modele13, Weinberg Matthew13, Davuluri Ashwini13, Danciu Sorin13, Almousalli Omar13, Bellamkonda Pallavi13, Nwakile Chinaulumogu13, Sokolowicz John13, Martin Enrico13, Kerut Kennety13, Pandey Amabrish13, Vijay Nampalli13, Bui Hanh13, Khan Waqar13, Morrow Michael13, Prashad Rakesh13, Bruemmer Dennis13,
Affiliation:
1. Duke Clinical Research Institute, Durham, North Carolina 2. Victorian Heart Institute, Monash University, Melbourne, Australia 3. University of Texas Southwestern Medical Center, Dallas 4. Parkland Health and Hospital System, Dallas, Texas 5. University of Michigan Medical School, Ann Arbor 6. University of North Carolina, Chapel Hill 7. Brigham and Women’s Hospital, Boston, Massachusetts 8. Saint Luke’s Health System, Kansas City, Missouri 9. Warren Alpert Medical School, Brown University, Providence, Rhode Island 10. School of Medicine, Wake Forest University, Winston-Salem, North Carolina 11. Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut 12. Eli Lilly and Company, Indianapolis, Indiana 13. for the COORDINATE–Diabetes Site Investigators
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
Publisher
American Medical Association (AMA)
Cited by
41 articles.
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