The growing number of patients who have chronic kidney disease (CKD), diabetes and hypertension is a public health challenge. CKD, diabetes and hypertension are 3 chronic medical conditions (CMCs) that increase morbidity, mortality, resource utilization and costs. Among adults in the United States the prevalence of CKD has increased from 10 to 14% over the past two decades and diabetes and hypertension are the 2 leading causes of CKD and end-stage renal disease. Important progress in identification of effective treatments for CKD, diabetes and hypertension has been made but there is a significant gap in translating these treatments to clinical practice. We have recently implemented a collaboratory primary care and nephrology care model at Parkland Health and Hospital System for patients with CKD in a predominantly minority population using a novel technology platform (Pieces- Parkland intelligent e-coordination and evaluation system) that allows us to leverage information from the electronic health record (EHR) to facilitate implementation of CKD care within primary care practices and medical homes in the community. In a study supported by NIDDK we are already observing improvements in BP control with a collaborative care model using Pieces to identify people with CKD and assist implementing recommended practices. We have also used Pieces to successfully develop various risk prediction models for readmissions and deaths in collaborating large health care systems. We now propose a randomized pragmatic trial, Improving Chronic Disease Management with Pieces (ICD-Pieces), in 4 large health care systems to test our model of care for patients with multimorbidity. The main hypothesis is that patients with CKD, hypertension and diabetes who receive care with a collaborative model of primary care-subspecialty care enhanced by novel information technology (Pieces) will have fewer hospitalizations, readmissions, CV events and deaths than patients receiving standard medical care. During the planning phase (UH2) we will establish the collaboratory and complete preparations at all participating sites for the study. In the implementation phase (UH3) we will conduct the randomized clinical trial pragmatic trial across the 4 large health care systems in the collaboratory. Our trial is pragmatic and randomized with rigorous controls and tests the implementation of several accepted and well-characterized interventions which will be coordinated and applied broadly to patients with CKD, hypertension and diabetes to evaluate clinically relevant outcomes. Our study has clearly defined milestones. The 4 participating large health care systems have different organizational structures, utilize different EHR and serve very different patient populations. We anticipate that findings from our study will provide a framework for future clinical trials and to advance the care of patients with multiple chronic medical conditions.

Public Health Relevance

Chronic kidney disease, diabetes and hypertension are 3 common medical conditions that are often present together in the same patients causing many complications. The purpose of this research is to study approaches to help primary care physicians treat these patients in more effective ways and lower their hospitalizations, heart problems and deaths.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Exploratory/Developmental Cooperative Agreement Phase II (UH3)
Project #
5UH3DK104655-04
Application #
9352232
Study Section
Special Emphasis Panel (ZAT1)
Program Officer
Narva, Andrew
Project Start
2015-09-01
Project End
2019-08-31
Budget Start
2017-09-01
Budget End
2018-08-31
Support Year
4
Fiscal Year
2017
Total Cost
Indirect Cost
Name
University of Texas Sw Medical Center Dallas
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
800771545
City
Dallas
State
TX
Country
United States
Zip Code
75390
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de Boer, Ian H; Kovesdy, Csaba P; Navaneethan, Sankar D et al. (2016) Pragmatic Clinical Trials in CKD: Opportunities and Challenges. J Am Soc Nephrol 27:2948-2954