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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.
- Miguel A Vazquez, George Oliver, Ruben Amarasingham, Venkatraghavan Sundaram, Kevin Chan, Chul Ahn, Song Zhang, Perry Bickel, Samir M Parikh, Barbara Wells, R Tyler Miller, Susan Hedayati, Jeffrey Hastings, Adeola Jaiyeola, Tuan-Minh Nguyen, Brett Moran, Noel Santini, Blake Barker, Ferdinand Velasco, Lynn Myers, Thomas P Meehan, Chester Fox, Robert D Toto, and ICD-Pieces Study Group.
- From the Department of Internal Medicine (M.A.V., P.B., S.M.P., R.T.M., S.H., B.B., R.D.T.) and the Peter O'Donnell Jr. School of Public Health (C.A., S.Z.), University of Texas Southwestern Medical Center, the Parkland Center for Clinical Innovation (G.O., V.S., A.J., T.-M.N.), Pieces Technologies (R.A.), Veterans Affairs of North Texas Health Care System (R.T.M., S.H., J.H.), Parkland Health (B.M., N.S.), and Texas Health Resources (F.V., L.M.) - all in Dallas; the National Institute of Diabetes and Digestive and Kidney Diseases (K.C.) and the National Heart, Lung, and Blood Institute (B.W.) - both in Bethesda, MD; ProHealth Physicians, Farmington, CT (T.P.M.); and the State University of New York, Buffalo (C.F.).
- N. Engl. J. Med. 2024 Apr 4; 390 (13): 119612061196-1206.
BackgroundDespite the availability of effective therapies for patients with chronic kidney disease, type 2 diabetes, and hypertension (the kidney-dysfunction triad), the results of large-scale trials examining the implementation of guideline-directed therapy to reduce the risk of death and complications in this population are lacking.MethodsIn this open-label, cluster-randomized trial, we assigned 11,182 patients with the kidney-dysfunction triad who were being treated at 141 primary care clinics either to receive an intervention that used a personalized algorithm (based on the patient's electronic health record [EHR]) to identify patients and practice facilitators to assist providers in delivering guideline-based interventions or to receive usual care. The primary outcome was hospitalization for any cause at 1 year. Secondary outcomes included emergency department visits, readmissions, cardiovascular events, dialysis, and death.ResultsWe assigned 71 practices (enrolling 5690 patients) to the intervention group and 70 practices (enrolling 5492 patients) to the usual-care group. The hospitalization rate at 1 year was 20.7% (95% confidence interval [CI], 19.7 to 21.8) in the intervention group and 21.1% (95% CI, 20.1 to 22.2) in the usual-care group (between-group difference, 0.4 percentage points; P = 0.58). The risks of emergency department visits, readmissions, cardiovascular events, dialysis, or death from any cause were similar in the two groups. The risk of adverse events was also similar in the trial groups, except for acute kidney injury, which was observed in more patients in the intervention group (12.7% vs. 11.3%).ConclusionsIn this pragmatic trial involving patients with the triad of chronic kidney disease, type 2 diabetes, and hypertension, the use of an EHR-based algorithm and practice facilitators embedded in primary care clinics did not translate into reduced hospitalization at 1 year. (Funded by the National Institutes of Health and others; ICD-Pieces ClinicalTrials.gov number, NCT02587936.).Copyright © 2024 Massachusetts Medical Society.
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