UH3 Project: Improving Chronic Disease Management with Pieces (ICD-Pieces™)

UH3 Project: Improving Chronic Disease Management with Pieces (ICD-Pieces™)

Principal Investigator:


Sponsoring Institution: University of Texas Southwestern Medical Center
Collaborators:

  • Parkland Health and Hospital System
  • Texas Health Resources
  • VA North Texas Health Care System
  • ProHealth Physicians of Connecticut

NIH Institute Providing Oversight: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Program Official: Susan Mendley, MD (NIDDK)
Project Scientist: Kevin Chan, MD (NIDDK)
ClinicalTrials.gov Identifier: NCT02587936
Study Locations: Texas, Connecticut
Trial Status: Enrollment completed

Study Snapshot

Trial Summary

Study question and significance: Chronic kidney disease, type 2 diabetes, and hypertension are common medical conditions that are often present together and cause many complications. Despite the availability of effective, guideline-directed therapies for these coexisting conditions, large clinical trials examining their implementation in clinical practice are lacking.

Design and setting: Cluster randomized clinical trial with 11,182 patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension recruited between July 2016 and June 2019 from 141 primary care practices in 4 large healthcare systems in the United States.

Intervention and methods: Patients were randomly assigned to receive either usual care or an intervention that used an electronic health record–based algorithm to identify patients and employed practice facilitators who worked with participating primary care providers and patients to meet blood pressure targets, promote use of appropriate medications, achieve goals for blood glucose control, and engage in other guideline-directed care. The primary outcome was hospitalization for any reason at 1 year. Key secondary outcomes included emergency department visits, cardiovascular events, and death.

Findings: At 1 year, the hospitalization rate for any cause was similar between the intervention and the usual care group. The risks of secondary outcomes, such as emergency department visits, cardiovascular events, and most adverse events, were also similar between the groups. Acute kidney injury was observed in more patients in the intervention group than in the usual care group.

Conclusions and relevance: A multicomponent primary care intervention for patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension did not reduce the hospitalization rate for these patients when compared to usual care.

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