Randomized Controlled Trial

. 2015 Oct 22:16:166.

doi: 10.1186/s12882-015-0168-4.

The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease

Delphine S Tuot^{1

2

3}, Alexandra Velasquez⁴, Charles E McCulloch⁵, Tanushree Banerjee^{6

7}, Yunnuo Zhu⁸, Chi-yuan Hsu⁹, Margaret Handley^{10

11}, Dean Schillinger^{12

13}, Neil R Powe^{14

15}

Affiliations

¹ Division of Nephrology, University of California, San Francisco, San Francisco, CA, 94143, USA. Delphine.tuot@ucsf.edu.
² Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Delphine.tuot@ucsf.edu.
³ Renal Center at San Francisco General Hospital, 1001 Potrero Avenue Bldg 100, Room 342, San Francisco, CA, 94110, USA. Delphine.tuot@ucsf.edu.
⁴ Division of Nephrology, University of California, San Francisco, San Francisco, CA, 94143, USA. Alexandra.Velasquez@ucsf.edu.
⁵ Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, 94143, USA. Charles.McCulloch@ucsf.edu.
⁶ Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. Tanushree.Banerjee@ucsf.edu.
⁷ Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Tanushree.Banerjee@ucsf.edu.
⁸ Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. YunnuoKatie.Zhu@ucsf.edu.
⁹ Division of Nephrology, University of California, San Francisco, San Francisco, CA, 94143, USA. Chi-yuan.Hsu@ucsf.edu.
¹⁰ Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. Margaret.Handley@ucsf.edu.
¹¹ Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, 94143, USA. Margaret.Handley@ucsf.edu.
¹² Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, 94143, USA. Dean.Schillinger@ucsf.edu.
¹³ Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Dean.Schillinger@ucsf.edu.
¹⁴ Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. Neil.Powe@ucsf.edu.
¹⁵ Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Neil.Powe@ucsf.edu.

PMID: 26494562
PMCID: PMC4618520
DOI: 10.1186/s12882-015-0168-4

Randomized Controlled Trial

The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease

Delphine S Tuot et al. BMC Nephrol. 2015.

. 2015 Oct 22:16:166.

doi: 10.1186/s12882-015-0168-4.

Authors

Affiliations

¹ Division of Nephrology, University of California, San Francisco, San Francisco, CA, 94143, USA. Delphine.tuot@ucsf.edu.
² Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Delphine.tuot@ucsf.edu.
³ Renal Center at San Francisco General Hospital, 1001 Potrero Avenue Bldg 100, Room 342, San Francisco, CA, 94110, USA. Delphine.tuot@ucsf.edu.
⁴ Division of Nephrology, University of California, San Francisco, San Francisco, CA, 94143, USA. Alexandra.Velasquez@ucsf.edu.
⁵ Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, 94143, USA. Charles.McCulloch@ucsf.edu.
⁶ Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. Tanushree.Banerjee@ucsf.edu.
⁷ Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Tanushree.Banerjee@ucsf.edu.
⁸ Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. YunnuoKatie.Zhu@ucsf.edu.
⁹ Division of Nephrology, University of California, San Francisco, San Francisco, CA, 94143, USA. Chi-yuan.Hsu@ucsf.edu.
¹⁰ Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. Margaret.Handley@ucsf.edu.
¹¹ Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, 94143, USA. Margaret.Handley@ucsf.edu.
¹² Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, 94143, USA. Dean.Schillinger@ucsf.edu.
¹³ Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Dean.Schillinger@ucsf.edu.
¹⁴ Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, 94143, USA. Neil.Powe@ucsf.edu.
¹⁵ Center for Vulnerable Populations at San Francisco General Hospital, San Francisco, CA, USA. Neil.Powe@ucsf.edu.

PMID: 26494562
PMCID: PMC4618520
DOI: 10.1186/s12882-015-0168-4

Abstract

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/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov, number: NCT01530958.

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Figures

**Fig. 1**
KARE incorporates components of the Chronic Care Model and integrates with a patient-centered medical home to enhance health outcomes

**Fig. 2**
KARE 2x2 factorial clinical randomized trial design

**Fig. 3**
CKD-ATSM blends health technology with personalized education and counseling

See this image and copyright information in PMC

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The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease

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The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease

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