Bringing Care to Patients: Patient-Centered Medical Home for Kidney Disease

Not Applicable

Completed

• Conditions: ESRD
• Interventions: Other: Patient-Centered Medical Home for Kidney Disease (PCMH-KD)

• Registration Number: NCT02270515
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2016-12-15
• Results First Submitted QC: 2017-02-22
• Status Verified: 2017-03
• Results First Posted: 2017-03-01
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCMH-KD dialysis care	Patient-Centered Medical Home for Kidney Disease (PCMH-KD)	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'.

Primary Outcome Measures

Name	Time	Method
Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models	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.
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted	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.
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted	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.

Trial Locations

Locations (2)

University of Illinois Hospital and Health Sciences System dialysis center; 🇺🇸 Chicago, Illinois, United States

Fresenius Medical Care Chicago Westside dialysis center; 🇺🇸 Chicago, Illinois, United States