This trial has been completed.

Condition esrd
Treatment patient-centered medical home for kidney disease (pcmh-kd)
Sponsor University of Illinois at Chicago
Collaborator Patient-Centered Outcomes Research Institute
Start date November 2013
End date August 2016
Trial size 175 participants
Trial identifier NCT02270515, IH-12-11-5420


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, health promoter, 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose health services research
Masking no masking
Dialysis care team is expanded to include a primary care doctor, nurse coordinator, health promoter, 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' (6 month prior to baseline).
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 health promoter to the care team.

Primary Outcomes

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
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
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

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title Bringing Care to Patients: A Patient-Centered Medical Home for Kidney Disease
Principal investigator Denise Hynes, PhD, MPH, RN
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 health promoters 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 health promoter. 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) health promoter 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 health promoters 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by University of Illinois at Chicago.