Navigating the Challenges of Chronic Kidney Disease (CKD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Debbie Camino, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
NCT01792661
First received: February 12, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Other: Enhanced MyChart
Other: Patient Navigator
Other: MyChart

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Navigating the Challenges of Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Change in Renal Function [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • CKD Knowledge and Awareness [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]

    CKD education is being measured with electronic clicks the number of times NKDEP patient education materials are accessed through Enhanced MyChart, NKF pre-ESRD curriculum.

    Similarly, the frequency of MyChart access of laboratory results and appointments specific to CKD awareness, Nephrology, CKD Clinic, Primary Care Physician, is being measured.

    Nutrition is also being similarly measured; NKDEP nutrition patient education materials, nutrition referral.

    Patient Navigator contact frequency and subsequent patient follow-up of laboratory work and medical appointments are the indicators of patient willingness to increase their CKD knowledge.



Enrollment: 209
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MyChart
The control group receives standard Cleveland Clinic care and has access to MyChart which is the standard Cleveland Clinic electronic PHR.
Other: 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.
Active Comparator: 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.
Other: 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.
Other Name: CKD Enhanced PHR
Active Comparator: 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.
Other: 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.
Other: 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.
Active Comparator: 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.
Other: 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.
Other Name: CKD Enhanced PHR
Other: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792661

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Debbie Camino
Investigators
Principal Investigator: Joseph Nally, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Debbie Camino, Program Manager Glickman Urological and Kidney Institute, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT01792661     History of Changes
Other Study ID Numbers: 12-072, R34DK094112-01
Study First Received: February 12, 2013
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Chronic Kidney Disease
Electronic Health Record
Personal Health Record
Chronic Kidney Disease registry
Glomerular Filtration Rate
Patient Navigator

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 27, 2014