Clinical trial NCT01792661: Navigating the Challenges of Chronic Kidney Disease
Official title: Navigating the Challenges of Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Electronic Health Record
Personal Health Record
Chronic Kidney Disease registry
Glomerular Filtration Rate
Patient Navigator
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-02-15
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The study's purpose is to address the challenges of providing stage-appropriate chronic kidney disease (CKD) education and care by developing innovative programs using a CKD Patient Navigator system and an EHR (electronic health record)-based enhanced electronic communication system specific for a CKD patient and her/his physicians/caregivers. The investigators plan a randomized controlled trial of these innovations to examine the utility and effectiveness of these special interventions.

The investigators' CKD registry aids in identifying patients for recruitment for the randomized control trial. Patients are randomized into one of four groups. The four groups are: 1) the control group using MyChart; 2) an enhanced personal health record (PHR) included in MyChart consisting of 35 websites chosen to disseminate CKD stage-specific goals of care and CKD education; 3) the patient navigator, a lay professional trained in the specifics of chronic kidney disease navigation with a focus on the needs of their patients based on the National Kidney Foundation Disease Outcomes Quality Initiative; 4) the patient navigator combined with the enhanced MyChart.

The investigators hypothesize that a CKD Patient Navigator program will develop a more prepared, proactive patient-caregiver team than usual care; the enhanced PHR will produce a more informed, engaged patient than usual care; the CKD Patient Navigator arm and enhanced PHR will demonstrate a slower rate of decline in eGFR (glomerular filtration rate) than usual care.

The results of this study will lay the foundation for a larger multi-center national clinical trial that will build upon the feasibility and knowledge gained from this planning grant.

Detailed description: The overall goal of this research is to assess the effects of innovative interventions for CKD on the decline in renal function among patients with CKD stages 3b or 4. First, a CKD Patient Navigator program was created, adapted from the use of Patient Navigators successfully in oncology. Second, an enhanced PHR was developed that uses electronic communication to disseminate CKD stage-specific goals of care and CKD education. Third, a randomized controlled trial is being conducted using a factorial design to investigate the clinical impact and cost-effectiveness of the two interventions - a CKD Patient Navigator and enhanced PHR compared to usual care for CKD Stage 3b/4 patients.

As a conceptual framework for the proposed study, the investigators are using the Chronic Care Model developed by Edward H. Wagner, M.D., Director of The MacColl Institute for Healthcare Innovation, Director of The Robert Wood Johnson Foundation national program "Improving Chronic Illness Care" and Senior Investigator at the Group Health Research Institute in Seattle. The model emphasizes a synergy between community, the health care system, technology and personal interactions to achieve optimal functional and clinical outcomes among people with chronic diseases. It has been adopted by the National Kidney Disease Education Program (NKDEP) to achieve many of their goals related to kidney disease.

With the help of the CKD registry, the investigators are recruiting patients from outpatient clinics at main campus and family health centers located in the surrounding Cleveland area. Patients are being recruited by a trained study coordinator. All patients are informed about study procedures and the purpose of the research, verbally and in a written informed consent document, two copies of which must be signed by both the patient and the study coordinator before enrollment. Upon enrollment, the patients will be provided with a $25 stipend.

The investigators identify from the CKD Registry and recruit eligible patients with CKD stage 3b (eGFR 30-44 ml/min/1.73 m2) or Stage 4 (eGFR 15-29 ml/min/1.73 m2) who meet the inclusion/exclusion criteria. The majority of data comes from the EHR derived CKD registry. The investigators obtain baseline demographic characteristics (age, gender, and race), comorbidities, and medication use, smoking status at the baseline visit. Further, CKD stage specific laboratory data will be collected routinely i.e., whether a laboratory parameter was measured or not and if measured, whether the laboratory measures and blood pressure are under the target limits. Details about nephrology, vascular access, and transplant referrals are obtained at baseline visit. The primary outcome of the study will be change in eGFR over the two-year study period.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* English speaking
* eGFR 15-45 ml/min
* patients residing in North East Ohio

Exclusion Criteria:

* mentally incompetent
* cancer
* terminal illness
* patients on dialysis
* patients who have had renal transplant.

Primary outcomes:
measure: Change in Renal Function
timeFrame: baseline and 1 year
Secondary outcomes:
measure: CKD Knowledge and Awareness
timeFrame: baseline and 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Joseph Nally, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Navaneethan SD, Jolly SE, Schold JD, Arrigain S, Saupe W, Sharp J, Lyons J, Simon JF, Schreiber MJ Jr, Jain A, Nally JV Jr. Development and validation of an electronic health record-based chronic kidney disease registry. Clin J Am Soc Nephrol. 2011 Jan;6(1):40-9. doi: 10.2215/CJN.04230510. Epub 2010 Nov 4.
citation: Navaneethan SD, Kandula P, Jeevanantham V, Nally JV Jr, Liebman SE. Referral patterns of primary care physicians for chronic kidney disease in general population and geriatric patients. Clin Nephrol. 2010 Apr;73(4):260-7. doi: 10.5414/cnp73260.
citation: Jolly SE, Burrows NR, Chen SC, Li S, Jurkovitz CT, Narva AS, Norris KC, Shlipak MG. Racial and ethnic differences in albuminuria in individuals with estimated GFR greater than 60 mL/min/1.73 m(2): results from the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2010 Mar;55(3 Suppl 2):S15-22. doi: 10.1053/j.ajkd.2009.09.034.
citation: Tonelli M, Muntner P, Lloyd A, Manns BJ, James MT, Klarenbach S, Quinn RR, Wiebe N, Hemmelgarn BR; Alberta Kidney Disease Network. Using proteinuria and estimated glomerular filtration rate to classify risk in patients with chronic kidney disease: a cohort study. Ann Intern Med. 2011 Jan 4;154(1):12-21. doi: 10.7326/0003-4819-154-1-201101040-00003.
citation: Chronic Kidney Disease Prognosis Consortium; Matsushita K, van der Velde M, Astor BC, Woodward M, Levey AS, de Jong PE, Coresh J, Gansevoort RT. Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis. Lancet. 2010 Jun 12;375(9731):2073-81. doi: 10.1016/S0140-6736(10)60674-5. Epub 2010 May 17.
citation: Freeman HP. Patient navigation: a community centered approach to reducing cancer mortality. J Cancer Educ. 2006 Spring;21(1 Suppl):S11-4. doi: 10.1207/s15430154jce2101s_4.
citation: Freund KM. Patient navigation: the promise to reduce health disparities. J Gen Intern Med. 2011 Feb;26(2):110-2. doi: 10.1007/s11606-010-1593-5. No abstract available.