The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease.
BACKGROUND
Chronic kidney disease (CKD) is common and is associated with excess mortality and morbidity. Better management could slow progression of disease, prevent metabolic complications, and reduce cardiovascular outcomes. Low patient awareness of CKD and ineffective patient-provider communication can impede such efforts. We developed provider and patient-directed interventions that harness health information technology to enhance provider recognition of CKD and delivery of guideline concordant care and augment patient understanding and engagement in CKD care.


METHODS
We report the design and protocol of the Kidney Awareness Registry and Education (KARE) Study, a 2x2 factorial randomized controlled trial that examines the impact of a multi-level intervention on health outcomes among low-income English, Spanish and Cantonese-speaking patients with CKD in a safety net system. The intervention includes: (1) implementation of a primary care electronic CKD registry that notifies practice teams of patients' CKD status and employs a patient profile and quarterly feedback to encourage provision of guideline-concordant care at point-of-care and via outreach; and (2) a language-concordant, culturally-sensitive self-management support program that consists of automated telephone modules, provision of low-literacy written patient-educational materials and telephone health coaching. The primary outcomes of the trial are changes in systolic blood pressure (BP) and the proportion of patients with BP control (≤ 140/90 mmHg) after one year. Secondary outcomes include patient understanding of CKD, participation in healthy behaviors, and practice team delivery of guideline-concordant CKD care.


CONCLUSIONS
Results from the KARE study will provide data on the feasibility, effectiveness, and acceptability of technology-based interventions that support primary care efforts at improving health outcomes among vulnerable patients with CKD.


BACKGROUND
ClinicalTrials.gov, number: NCT01530958.
Division of Nephrology, University of California, San Francisco, San Francisco, CA, 94143, USA. Delphine.tuot@ucsf.edu.|Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Delphine.tuot@ucsf.edu.|Renal Center at San Francisco General Hospital, 1001 Potrero Avenue Bldg 100, Room 342, San Francisco, CA, 94110, USA. Delphine.tuot@ucsf.edu.
Delphine S
DS
Tuot
Division of Nephrology, University of California, San Francisco, San Francisco, CA, 94143, USA. Alexandra.Velasquez@ucsf.edu.
Alexandra
A
Velasquez
Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, 94143, USA. Charles.McCulloch@ucsf.edu.
Charles E
CE
McCulloch
Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. Tanushree.Banerjee@ucsf.edu.|Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Tanushree.Banerjee@ucsf.edu.
Tanushree
T
Banerjee
Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. YunnuoKatie.Zhu@ucsf.edu.
Yunnuo
Y
Zhu
Division of Nephrology, University of California, San Francisco, San Francisco, CA, 94143, USA. Chi-yuan.Hsu@ucsf.edu.
Chi-yuan
CY
Hsu
Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. Margaret.Handley@ucsf.edu.|Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, 94143, USA. Margaret.Handley@ucsf.edu.
Margaret
M
Handley
Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, 94143, USA. Dean.Schillinger@ucsf.edu.|Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Dean.Schillinger@ucsf.edu.
Dean
D
Schillinger
Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. Neil.Powe@ucsf.edu.|Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Neil.Powe@ucsf.edu.
Neil R
NR
Powe
D001213:Asian; D001794:Blood Pressure; D003142:Communication; D054521:Cultural Competency; D019983:Guideline Adherence; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D057220:Health Literacy; D006630:Hispanic or Latino; D006801:Humans; D007802:Language; D008490:Medical Informatics; D010348:Patient Care Team / Q000592:standards; D010353:Patient Education as Topic; D010817:Physician-Patient Relations; D017410:Practice Guidelines as Topic; D011320:Primary Health Care; D012042:Registries; D051436:Renal Insufficiency, Chronic / Q000503:physiopathology / Q000628:therapy*; D012107:Research Design; D012495:San Francisco; D012648:Self Care; D035862:Vulnerable Populations