Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease.

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
04 Apr 2024
Historique:
medline: 10 4 2024
pubmed: 10 4 2024
entrez: 10 4 2024
Statut: ppublish

Résumé

Despite 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. In 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. We 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%). In 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.).

Sections du résumé

BACKGROUND BACKGROUND
Despite 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.
METHODS METHODS
In 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.
RESULTS RESULTS
We 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%).
CONCLUSIONS CONCLUSIONS
In 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.).

Identifiants

DOI: 10.1056/NEJMoa2311708 PMID: 38598574
pubmed: 38598574
doi: 10.1056/NEJMoa2311708
doi:

Banques de données

ClinicalTrials.gov
['NCT02587936']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1196-1206

Subventions

Organisme : NIH HHS
ID : UH3DK104655
Pays : United States

Investigateurs

Miguel Vazquez (M)
Robert Toto (R)
George Oliver (G)
Venkatraghavan Sundaram (V)
Chul Ahn (C)
Song Zhang (S)
Tuan-Minh Nguyen (TM)
Susan Mendley (S)
Kevin Chan (K)
Andrew Narva (A)
Barbara Wells (B)
Ferdinand Velasco (F)
Lynn Myers (L)
Janet Holden (J)
Maryam Sajjad (M)
Tony Keller (T)
Brett Moran (B)
Noel Santini (N)

Informations de copyright

Copyright © 2024 Massachusetts Medical Society.

Auteurs

Miguel A Vazquez (MA)

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.).
ORCID: 0009-0002-8859-9494

George Oliver (G)

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.).

Ruben Amarasingham (R)

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.).

Venkatraghavan Sundaram (V)

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.).
ORCID: 0000-0002-8104-5627

Kevin Chan (K)

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.).

Chul Ahn (C)

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.).

Song Zhang (S)

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.).

Perry Bickel (P)

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.).

Samir M Parikh (SM)

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.).

Barbara Wells (B)

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.).

R Tyler Miller (RT)

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.).

Susan Hedayati (S)

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.).

Jeffrey Hastings (J)

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.).

Adeola Jaiyeola (A)

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.).

Tuan-Minh Nguyen (TM)

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.).

Brett Moran (B)

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.).

Noel Santini (N)

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.).

Blake Barker (B)

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.).

Ferdinand Velasco (F)

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.).

Lynn Myers (L)

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.).

Thomas P Meehan (TP)

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.).

Chester Fox (C)

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.).

Robert D Toto (RD)

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.).

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