Our long term objective related to this project is to develop, demonstrate and promote widespread implementation of support approaches for patients and care providers that optimize chronic kidney disease (CKD) patients'adherence to the best available disease management regimen. CKD is a large and costly public health problem in the U.S. that will continue to grow with the aging of the population and increasing incidences of obesity, hypertension and diabetes. Although evidence-based treatments and self-management regimens are available that are effective in slowing progression of CKD to end-stage renal disease, inadequate awareness and coordination among patients and primary care providers has prevented widespread implementation of those approaches. For this planning grant, we propose to conduct a clinical trial to test two interactive informational approaches to improving chronic care and ultimately outcomes of CKD patients. Both approaches will follow the well-established chronic care model to improve CKD outcomes for CKD Stage 3b/4 patients.
In Specific Aim 1, we will adapt the model of individual patient navigators employed successfully in the oncology field to create a CKD Patient Navigator program to promote adherence to the chronic care regimen. We hypothesize that a CKD Patient Navigator program will produce a more prepared, proactive patient-caregiver group than usual care.
In Specific Aim 2, we will work with our existing electronic health record-based personal health record (PHR) and enhance it to use electronic communication to disseminate CKD education and stage-specific goals of care for CKD Stage 3b/4 patients. We hypothesize that an enhanced PHR will result in a more informed, activated patient than usual care.
In Specific Aim 3, we will conduct a prospective randomized clinical trial using a factorial design to investigate the clinical impact and cost-effectiveness of the two interventions described in Specific Aims 1 and 2 for patients with stage 3b or stage 4 CKD. Two hundred and eight patients will be recruited for the trial from among nearly 18,000 patients with stage 3b/4 CKD identified in the Cleveland Clinic Health Systems EHR-based CKD Registry developed and validated by us. We hypothesize that patients in the patient navigator arm and those in the enhanced PHR arm will have a slower rate of decline in estimated glomerular filtration rate than patients receiving only usual care. The results of this study will lay the foundation for a larger multi-center national clinical trial tha will build upon the feasibility and knowledge gained from this planning grant to work towards translating effective interventions into routine clinical practice and ultimately improving the car of those with CKD.

Public Health Relevance

Narrative More than 16 million Americans suffer from chronic kidney disease (CKD). It is often associated with other diseases such as diabetes and hypertension, and patients with CKD have an increased risk for cardiovascular disease and death. Some patients with CKD will develop end-stage renal disease requiring dialysis or kidney transplant. Interventions effective in slowing the progression of CKD are available, but published guidelines for effective management of CKD have not been widely enacted in the medical communities, and many CKD patients are not meeting disease management goals per current guidelines. Patient navigators and/or enhanced personal health records customized for CKD may overcome barriers and improve coordination among patients, doctors, nurses and health care staff;optimize the use of resources within the health system and community;and empower patients with pertinent health knowledge, resulting in better adherence to recommended care for CKD and ultimately improved clinical outcomes.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Planning Grant (R34)
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Study Section
Special Emphasis Panel (ZDK1-GRB-R (O1))
Program Officer
Narva, Andrew
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Cleveland Clinic Lerner
Internal Medicine/Medicine
Schools of Medicine
United States
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Navaneethan, Sankar D; Jolly, Stacey E; Schold, Jesse D et al. (2017) Pragmatic Randomized, Controlled Trial of Patient Navigators and Enhanced Personal Health Records in CKD. Clin J Am Soc Nephrol 12:1418-1427
Navaneethan, Sankar D; Schold, Jesse D; Arrigain, Susana et al. (2016) Body mass index and causes of death in chronic kidney disease. Kidney Int 89:675-82
Saeed, Fahad; Adil, Malik M; Kaleem, Umar M et al. (2016) Outcomes of In-Hospital Cardiopulmonary Resuscitation in Patients with CKD. Clin J Am Soc Nephrol 11:1744-1751
Navaneethan, Sankar D; Schold, Jesse D; Huang, Haiquan et al. (2016) Mortality Outcomes of Patients with Chronic Kidney Disease and Chronic Obstructive Pulmonary Disease. Am J Nephrol 43:39-46
Nakhoul, Georges N; Huang, Haiquan; Arrigain, Susana et al. (2015) Serum Potassium, End-Stage Renal Disease and Mortality in Chronic Kidney Disease. Am J Nephrol 41:456-63
Jolly, Stacey E; Navaneethan, Sankar D; Schold, Jesse D et al. (2015) Development of a chronic kidney disease patient navigator program. BMC Nephrol 16:69
Navaneethan, Sankar D; Schold, Jesse D; Arrigain, Susana et al. (2015) Cause-Specific Deaths in Non-Dialysis-Dependent CKD. J Am Soc Nephrol 26:2512-20
Toledo, Clarisse; Thomas, George; Schold, Jesse D et al. (2015) Renal resistive index and mortality in chronic kidney disease. Hypertension 66:382-8
Nakhoul, Georges N; Schold, Jesse D; Arrigain, Susana et al. (2015) Implantable cardioverter-defibrillators in patients with CKD: a propensity-matched mortality analysis. Clin J Am Soc Nephrol 10:1119-27
Navaneethan, Sankar D; Wehbe, Edgard; Heresi, Gustavo A et al. (2014) Presence and outcomes of kidney disease in patients with pulmonary hypertension. Clin J Am Soc Nephrol 9:855-63

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