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

ESRD Clinical Trial

— PCMH-KD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02270515
• Other study ID #: IH-12-11-5420
• Status: Active, not recruiting
• Phase: N/A
• First received: October 16, 2014
• Last updated: October 3, 2016
• Start date: November 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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, 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• ESRD
• Kidney Diseases

Intervention

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 health promoter to the care team.

Locations

Country	Name	City	State
United States	Fresenius Medical Care Chicago Westside dialysis center	Chicago	Illinois
United States	University of Illinois Hospital and Health Sciences System dialysis center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Porter AC, Fitzgibbon ML, Fischer MJ, Gallardo R, Berbaum ML, Lash JP, Castillo S, Schiffer L, Sharp LK, Tulley J, Arruda JA, Hynes DM. Rationale and design of a patient-centered medical home intervention for patients with end-stage renal disease on hemodialysis. Contemp Clin Trials. 2015 May;42:1-8. doi: 10.1016/j.cct.2015.02.006. Epub 2015 Feb 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Kidney Disease Quality of Life (KDQOL) is an instrument used to assess the quality of life of patients with kidney disease. It measures the impact of kidney disease on daily life in the previous four weeks and in a patient's overall life. KDQOL will be assessed at baseline (prior to intervention) and then every 6 months during the intervention period.	4 weeks	No