ESRDPCMH-KDNCT02270515
Bringing Care to Patients: Patient-Centered Medical Home for Kidney Disease
A study testing Patient-Centered Medical Home for Kidney Disease (PCMH-KD) in people with ESRD, run by University of Illinois Chicago at 2 sites in United States.
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, community… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- What is being tested?
- Patient-Centered Medical Home for Kidney Disease (PCMH-KD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current patient receiving hemodialysis at two participating dialysis centers who are able to provide informed consent
Who cannot join
- Not a patient at one of the two participating dialysis centers or not able to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fresenius Medical Care Chicago Westside dialysis center
Chicago, Illinois, 60608
University of Illinois Hospital and Health Sciences System dialysis center
Chicago, Illinois, 60612
About this study
Official title: Bringing Care to Patients: A Patient-Centered Medical Home for Kidney Disease
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.
Read the 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.
- Conditions
- ESRD
- Being tested
- Patient-Centered Medical Home for Kidney Disease (PCMH-KD)
- Keywords
- Patient-Centered Care, Medical Home
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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'. Receives: Other: Patient-Centered Medical Home for Kidney Disease (PCMH-KD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (0) to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Denise M. Hynes, PhD, MPH, RN, University of Illinois Chicago
- Investigators
- Denise Hynes, PhD, MPH, RN, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270515
- Sponsor's protocol ID
- IH-12-11-5420
- Acronym
- PCMH-KD
- Status last verified
- Mar 2017
- First submitted
- 16 Oct 2014
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 25735489Cukor 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.
PubMed 27197911Hynes 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.
PubMed 26622920Hynes 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.
PubMed 27769897
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bringing Care to Patients: A Patient-Centered Medical Home for Kidney Disease
- ClinicalTrials.gov ID
- NCT02270515
- Acronym / sponsor ID
- PCMH-KD / IH-12-11-5420
- Conditions
- ESRD
- Keywords
- Patient-Centered Care, Medical Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Nov 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Posted 1 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCMH-KD dialysis care | Experimental | Other: 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'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current patient receiving hemodialysis at two participating dialysis centers who are able to provide informed consent
Key exclusion criteria (1 listed)
- Not a patient at one of the two participating dialysis centers or not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | PCMH-KD dialysis care |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25735489Porter 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.
- Background: PubMed 27197911Cukor 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.
- Background: PubMed 26622920Hynes 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.
- Results publication: PubMed 27769897Hynes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Hynes, PhD, MPH, RN principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Centered Medical Home for Kidney Disease (PCMH-KD) in people with ESRD, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270515, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.