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: Pragmatic cluster randomized trial involving 11,182 patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension who received care in 141 primary care clinics in 4 large healthcare systems.

Intervention and methods: Patients were randomly assigned to either usual care or an intervention in which the study team used an algorithm to identify patients in the electronic health record in real time. In the intervention group, practice facilitators worked with the participating primary care providers and patients to meet blood pressure targets, promote the use of appropriate medications, achieve goals for blood glucose control, and engage in other guideline-directed care. The intervention period lasted 12 months, and the primary outcome was hospitalization for any reason.

Findings: The large, diverse study population—of whom 20% were Black and almost 20% were Hispanic or Latino—was representative of the population with chronic kidney disease, type 2 diabetes, and hypertension in the United States. The hospitalization rates were similar between the intervention group and the usual care group (between-group difference, 0.4 percentage points; P = .58). Rates of key secondary outcomes, such as emergency department visits and cardiovascular events, were also similar between the groups.

Conclusions and relevance: The use of an electronic health record–based algorithm and practice facilitators embedded in primary care clinics did not translate into better disease control or reduced hospitalization. The trial provides lessons for future embedded pragmatic trials that are designed to test the delivery of multicomponent interventions for patients with multiple chronic conditions.

NIH Project Information