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

• 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: University of Illinois at Chicago
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Denise M. Hynes, PhD, MPH, RN, University of Illinois at Chicago

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 175 participants
• Allocation: N/A
• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Denise Hynes, PhD, MPH, RN; University of Illinois at Chicago

More Information

Publications of Results:

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.

Other Publications:

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.

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):1703-12. doi: 10.2215/CJN.09780915. Epub 2016 May 19. Review.

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.

• 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
• Other Study ID Numbers: IH-12-11-5420
• First Posted: October 21, 2014
• 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:

Kidney Diseases; Urologic Diseases