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Bringing Care to Patients: Patient-Centered Medical Home for Kidney Disease (PCMH-KD)

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ClinicalTrials.gov Identifier: NCT02270515
Recruitment Status : Completed
First Posted : October 21, 2014
Results First Posted : March 1, 2017
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Denise M. Hynes, PhD, MPH, RN, University of Illinois at Chicago

Brief Summary:
This study will implement and evaluate a patient-centered medical home for kidney disease (PCMH-KD) compared to the usual model of dialysis care. Patients will be observed for an initial baseline period under the usual care model and then the usual dialysis care team will be expanded to include a pharmacist, community health worker, nurse coordinator and a primary care doctor. Outcomes of interest will be assessed at baseline and then every 6 months after the PCMH-KD intervention commences.

Condition or disease Intervention/treatment Phase
ESRD Other: Patient-Centered Medical Home for Kidney Disease (PCMH-KD) Not Applicable

Detailed Description:

Patients with end-stage renal disease (ESRD), have unique and complex care needs associated with renal disease and common comorbidities (e.g., diabetes, hypertension), and under the current care model, receive fragmented care from multiple providers at multiple locations. ESRD patients typically spend three to five hours undergoing dialysis three days a week. Scheduling and traveling to other appointments are difficult to manage, increase patient and caregiver burden, and reduce patients' quality of life. These challenges keep many ESRD patients from receiving care for other conditions outside of the dialysis setting, resulting in higher rates of complications, and emergent healthcare use.

The patient-centered medical home (PCMH) model has been proposed as a solution to patients with complex needs such as those with ESRD. The purpose of this project is to compare a PCMH model of care with the usual care of ESRD patients and their caregivers. We propose to enhance the usual care team for ESRD patients by providing a primary care doctor in the context of regularly scheduled dialysis sessions and by adding community health workers to help support patients and their caregivers. Patient and family stakeholders and care team members will assist in the design and refinement of the PCMH model.

We plan to implement this model at the University of Illinois Hospital and Health Sciences System (UIHS) dialysis center and a local Fresenius Medical Care dialysis center. Patients receiving dialysis at participating centers will receive an initial comprehensive care visit followed by ongoing care from a multispecialty provider team during the patients' regularly scheduled dialysis visits. Each patient's care team will include a kidney doctor, a primary care doctor, a nurse coordinator, a dialysis nurse, a dietician, a pharmacist, a social worker, and a community health worker. The primary care doctor will be available in the dialysis clinic to provide general and preventive care to the patient before or after dialysis sessions. This doctor would also coordinate care with other specialists/clinicians on the patient's care team. The trained, bilingual (English/Spanish) community health worker will assist with making and rescheduling appointments, obtaining transportation, and reinforcing education components.

We expect that this approach will increase patient access to care for other conditions and will increase care coordination and communication among members of the patient's care team. These improvements could potentially increase the likelihood of preventing complications or identifying problems earlier and allow for a more successful treatment. We expect that this enhanced care team will reduce emergency room visits and hospitalizations for dialysis patients. In addition, we anticipate that the addition of community health workers to the clinical team will help support and educate patients and their caregivers and as a result, patient quality of life will improve and caregiver burden may be reduced.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Bringing Care to Patients: A Patient-Centered Medical Home for Kidney Disease
Study Start Date : November 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PCMH-KD dialysis care
Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and pharmacist. Enrolled patients are observed for an initial baseline period receiving care under the usual dialysis care model called the 'usual dialysis care phase'.
Other: Patient-Centered Medical Home for Kidney Disease (PCMH-KD)
A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team.




Primary Outcome Measures :
  1. Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted [ Time Frame: Baseline (0) to 18 months ]
    Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.

  2. Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted [ Time Frame: Baseline (0) to 18 months ]

    Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.

    Adjusted means are from random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.


  3. Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models [ Time Frame: Baseline (0) to 18 months ]
    Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current patient receiving hemodialysis at two participating dialysis centers who are able to provide informed consent

Exclusion Criteria:

  • Not a patient at one of the two participating dialysis centers or not able to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270515


Locations
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United States, Illinois
Fresenius Medical Care Chicago Westside dialysis center
Chicago, Illinois, United States, 60608
University of Illinois Hospital and Health Sciences System dialysis center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Denise Hynes, PhD, MPH, RN University of Illinois at Chicago

Publications of Results:
Other Publications:
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Responsible Party: Denise M. Hynes, PhD, MPH, RN, Professor, College of Medicine; Research Affiliate, School of Public Health; and, Biomedical Informatics Core Director, Center for Clinical and Translational Sciences (CCTS),, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02270515     History of Changes
Other Study ID Numbers: IH-12-11-5420
First Posted: October 21, 2014    Key Record Dates
Results First Posted: March 1, 2017
Last Update Posted: April 7, 2017
Last Verified: March 2017
Keywords provided by Denise M. Hynes, PhD, MPH, RN, University of Illinois at Chicago:
Patient-Centered Care
Medical Home
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases