Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
209 participants
INTERVENTIONAL
2012-02-29
2015-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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MyChart
The control group receives standard Cleveland Clinic care and has access to MyChart which is the standard Cleveland Clinic electronic PHR.
MyChart
Sign-up to MyChart is optional for Cleveland Clinic patients. Subjects enrolled into the study are signed-up for MyChart (if not already signed-up) during the consenting process.
Enhanced MyChart
The enhanced PHR functionality adds the ability to securely receive and review CKD-education related messages to the existing features available to all PHR users. The CKD-educational related messages can be automatically delivered at pre-defined intervals and customized for each individual patient at their discretion and convenience.
Enhanced MyChart
Subjects randomized into the MyChart receive an additional site on their MyChart containing 35 extra educational links specific to CKD, targetting care for stage 3b and stage 4 patients.
Patient Navigator
A tracking log is kept by the Patient Navigator of each interaction regarding type of encounter, length of encounter, barriers addressed, and actions that occurred, adapting what is in use for the NIH-funded Patient Navigator program.
Patient Navigator
The Patient Navigator aids subjects in education of their CKD, timely scheduling of appointments, plus determining and overcoming barriers to their CKD health care. The Patient Navigator's job is not part of routine medical care.
MyChart
Sign-up to MyChart is optional for Cleveland Clinic patients. Subjects enrolled into the study are signed-up for MyChart (if not already signed-up) during the consenting process.
Patient Navigator and Enhanced MyChart
Combines patient self empowerment, regarding their CKD, with the Enhanced MyChart along with the aid and direction of a Patient Navigator.
Enhanced MyChart
Subjects randomized into the MyChart receive an additional site on their MyChart containing 35 extra educational links specific to CKD, targetting care for stage 3b and stage 4 patients.
Patient Navigator
The Patient Navigator aids subjects in education of their CKD, timely scheduling of appointments, plus determining and overcoming barriers to their CKD health care. The Patient Navigator's job is not part of routine medical care.
Interventions
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Enhanced MyChart
Subjects randomized into the MyChart receive an additional site on their MyChart containing 35 extra educational links specific to CKD, targetting care for stage 3b and stage 4 patients.
Patient Navigator
The Patient Navigator aids subjects in education of their CKD, timely scheduling of appointments, plus determining and overcoming barriers to their CKD health care. The Patient Navigator's job is not part of routine medical care.
MyChart
Sign-up to MyChart is optional for Cleveland Clinic patients. Subjects enrolled into the study are signed-up for MyChart (if not already signed-up) during the consenting process.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* English speaking
* eGFR 15-45 ml/min
* patients residing in North East Ohio
Exclusion Criteria
* cancer
* terminal illness
* patients on dialysis
* patients who have had renal transplant.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Joseph Nally, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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12-072
Identifier Type: -
Identifier Source: org_study_id
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