Navigating the Challenges of Chronic Kidney Disease

NCT01792661 | Completed DMC

• 2 other identifiers: 12-072R34DK094112-01
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Electronic Health Record; Personal Health Record; Chronic Kidney Disease registry; Glomerular Filtration Rate; Patient Navigator

Outcome Measures

Primary Outcomes (1)

• Change in Renal Function

  CKD stage specific laboratory data is being collected quarterly. Most of the data will come from the CKD registry, supplemented by the data collection system from the EHR set up by the Cleveland Clinic Department of Quantitative Health Sciences (QHS). Lab and urine measures are: eGFR, urine albumin to creatinine ratio, parathyroid hormone, 25-OH vitamin D, low density lipoprotein, hemoglobin, calcium and phosphorus. Clinical targets are: blood pressure, LDL, 25-OH Vitaming D. Preparation for possible transition to End Stage Renal Disease (ESRD): Nephrology referral, vascular access referral, transplant referral. Whether renoprotective medications are prescribed, such as ACEi and ARB.

  baseline and 1 year

Secondary Outcomes (1)

• CKD Knowledge and Awareness

  baseline and 1 year

Study Arms (4)

MyChart

ACTIVE COMPARATOR

The control group receives standard Cleveland Clinic care and has access to MyChart which is the standard Cleveland Clinic electronic PHR.

Other: MyChart

Enhanced MyChart

ACTIVE COMPARATOR

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.

Other: Enhanced MyChart

Patient Navigator

ACTIVE COMPARATOR

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.

Other: Patient Navigator; Other: MyChart

Patient Navigator and Enhanced MyChart

ACTIVE COMPARATOR

Combines patient self empowerment, regarding their CKD, with the Enhanced MyChart along with the aid and direction of a Patient Navigator.

Other: Enhanced MyChart; Other: Patient Navigator

Interventions

Enhanced MyChart OTHER

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.

Also known as: CKD Enhanced PHR

Enhanced MyChart; Patient Navigator and Enhanced MyChart

Patient Navigator OTHER

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.

Patient Navigator; Patient Navigator and Enhanced MyChart

MyChart OTHER

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.

MyChart; Patient Navigator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (7)

• 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.

  PMID: 21051745 BACKGROUND

• 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.

  PMID: 20353733 BACKGROUND

• 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.

  PMID: 20172444 BACKGROUND

• 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.

  PMID: 21200034 BACKGROUND

• 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.

  PMID: 20483451 BACKGROUND

• 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.

  PMID: 17020496 BACKGROUND

• 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.

  PMID: 21161422 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Joseph Nally, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)