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

NCT02270515 | Completed Results DMC

• 1 other identifier: IH-12-11-5420
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 2

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.

Conditions

ESRD

Keywords

Patient-Centered Care; Medical Home

Outcome Measures

Primary Outcomes (3)

• Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted

  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.

  Baseline (0) to 18 months

• Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted

  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.

  Baseline (0) to 18 months

• Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models

  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.

  Baseline (0) to 18 months

Study Arms (1)

PCMH-KD dialysis care

EXPERIMENTAL

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)

Interventions

Patient-Centered Medical Home for Kidney Disease (PCMH-KD) OTHER

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.

PCMH-KD dialysis care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current patient receiving hemodialysis at two participating dialysis centers who are able to provide informed consent

You may not qualify if:

• Not a patient at one of the two participating dialysis centers or not able to provide informed consent

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Fresenius Medical Care Chicago Westside dialysis center

Chicago, Illinois, 60608, United States

Location

University of Illinois Hospital and Health Sciences System dialysis center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• 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.

  PMID: 25735489 BACKGROUND

• 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.

  PMID: 27197911 BACKGROUND

• 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.

  PMID: 26622920 BACKGROUND

• 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.

  PMID: 27769897 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Subjects were not randomized to the intervention, although their experience prior to the intervention (baseline measures) served as the historical control. Only two sites were included in the study.

Results Point of Contact

• Title: Dr. Denise M. Hynes, Professor, College of Medicine
• Organization: University of Illinois, Chicago

dhynes@uic.edu

312-355-0083

Study Officials

• Denise Hynes, PhD, MPH, RN

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, College of Medicine; Research Affiliate, School of Public Health; and, Biomedical Informatics Core Director, Center for Clinical and Translational Sciences (CCTS),

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 21, 2014
• Study Start: November 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 7, 2017
• Results First Posted: March 1, 2017

Record last verified: 2017-03

Locations

US (2)