Clinical trial NCT02270515: Bringing Care to Patients: Patient-Centered Medical Home for Kidney Disease
Official title: Bringing Care to Patients: A Patient-Centered Medical Home for Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ESRD
Keywords: Patient-Centered Care
Medical Home
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-10-21
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted
timeFrame: Baseline (0) to 18 months
measure: Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted
timeFrame: Baseline (0) to 18 months
measure: Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models
timeFrame: Baseline (0) to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Fresenius Medical Care Chicago Westside dialysis center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System dialysis center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Denise Hynes, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cukor D, Cohen LM, Cope EL, Ghahramani N, Hedayati SS, Hynes DM, Shah VO, Tentori F, Unruh M, Bobelu J, Cohen S, Dember LM, Faber T, Fischer MJ, Gallardo R, Germain MJ, Ghahate D, Grote N, Hartwell L, Heagerty P, Kimmel PL, Kutner N, Lawson S, Marr L, Nelson RG, Porter AC, Sandy P, Struminger BB, Subramanian L, Weisbord S, Young B, Mehrotra R. Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1703-1712. doi: 10.2215/CJN.09780915. Epub 2016 May 19.
citation: Hynes DM, Buscemi J, Quintiliani LM; Society of Behavioral Medicine Health Policy Committee. Society of Behavioral Medicine (SBM) position statement: SBM supports increased efforts to integrate community health workers into the patient-centered medical home. Transl Behav Med. 2015 Dec;5(4):483-5. doi: 10.1007/s13142-015-0340-1. Epub 2015 Aug 28.
citation: Hynes DM, Fischer MJ, Schiffer LA, Gallardo R, Chukwudozie IB, Porter A, Berbaum M, Earheart J, Fitzgibbon ML. Evaluating a novel health system intervention for chronic kidney disease care using the RE-AIM framework: Insights after two years. Contemp Clin Trials. 2017 Jan;52:20-26. doi: 10.1016/j.cct.2016.10.003. Epub 2016 Oct 18.