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Pathways Project: Kidney Supportive Care

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ClinicalTrials.gov Identifier: NCT04125537
Recruitment Status : Unknown
Verified June 2019 by George Washington University.
Recruitment status was:  Active, not recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborators:
West Virginia University Research Corporation
Gordon and Betty Moore Foundation
Coalition for Supportive Care of Kidney Patients
Stanford University
Information provided by (Responsible Party):
George Washington University

Brief Summary:

The Pathways Collaborative is the first attempt to implement supportive (palliative) kidney care at multiple sites in the United States. While supportive kidney care is growing in other countries, notably Canada, Australia, and Great Britain, it is not yet known how to integrate it into the unique nephrology environment in the United States. In Phase 1 of Pathways (completed), we developed an evidence-based change packet of 14 best practices for integrating supportive care practices into the continuum of care for patients with end stage kidney disease (ESKD). In Phase 2 (described in this application), we will conduct a learning collaborative to help up to 15 dialysis and CKD centers implement these best practices. The learning collaborative is based on the IHI Collaborative Model for Achieving Breakthrough Improvement. This model is a tested systematic approach to quality improvement designed to help organizations close the gap between current and future practice based on evidence-based best practices.

The Pathways Project faculty will work with up to 15 change teams at dialysis centers to create a system to identify seriously ill patients with kidney disease; conduct conversations with them so that their values, preferences, and goals for current and future medical treatment are known and respected; assess and address patients' physical, psychological and spiritual needs; and coordinate care throughout the healthcare system so patients receive only the care they want in settings in which they wish to be.


Condition or disease Intervention/treatment
Kidney Diseases Chronic Kidney Diseases End Stage Renal Disease End Stage Renal Disease on Dialysis Chronic Kidney Disease Requiring Chronic Dialysis Behavioral: IHI Breakthrough Collaborative Model

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Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Pathways Project Collaborative Phase II: Implementation of Kidney Supportive Care in Practice
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Dialysis Centers
Dialysis Center staff participating in the collaborative learning activities. These staff then implement the best practices for seriously ill patients in their setting via quality improvement activities around identifying seriously ill patients, shared-decision making/advanced care planning, palliative dialysis and dialysis withdrawal.
Behavioral: IHI Breakthrough Collaborative Model
Staff participants participate in a quality improvement/collaborative learning model that includes three in-person learning sessions, and three activity sessions during which staff teams at each site use quality improvement processes to implement best practices from the change package. Technical assistance, education, and quality improvement coaching are provided to the site staff teams throughout the project.

Chronic Kidney Disease Clinics
Chronic Kidney Disease Clinic staff participating in the collaborative learning activities. These staff then implement the best practices for seriously ill patients in their setting via quality improvement activities around identifying seriously ill patients, shared-decision making/advanced care planning, and medical management without dialysis.
Behavioral: IHI Breakthrough Collaborative Model
Staff participants participate in a quality improvement/collaborative learning model that includes three in-person learning sessions, and three activity sessions during which staff teams at each site use quality improvement processes to implement best practices from the change package. Technical assistance, education, and quality improvement coaching are provided to the site staff teams throughout the project.




Primary Outcome Measures :
  1. Change in Patient Reported Quality of Communication [ Time Frame: [Time Frame: Baseline (June 2019); Post Intervention- After 3rd Action Period (Late 2020)] ]
    The primary patient reported outcome for the intervention will be patient reported quality of end of life communication, as measured by the Engelberg quality of communication questionnaire, a subscale on end of life communication.

  2. Change in Comprehensive advance care planning documentation [ Time Frame: [Time Frame: Baseline (June 2019); Post Intervention- After 3rd Action Period (Late 2020)] ]
    The comprehensiveness of advance care planning as documented in dialysis center or CKD clinic chart


Secondary Outcome Measures :
  1. Change in Patient reported Outcome Measure: Advance Care Planning Engagement [ Time Frame: Baseline (June 2019) and after 3rd Action period (late 2020) ]
    Additional patient reported outcome measures include the change in advance care planning engagement reported from patient interview from baseline to follow up

  2. Change in Patient Perception of Shared-Decision making [ Time Frame: Baseline (June 2019) and after 3rd Action period (late 2020) ]
    Additional patient reported outcome measures including patient perception of shared-decision making in their kidney health care team, which is reported from the patient interview at baseline and follow-up

  3. Change in patient reported outcome about communication about end-of-life [ Time Frame: Baseline (June 2019) and after 3rd Action period (late 2020) ]
    Additional patient reported outcome measures including communication between patient and health care provider about end of life is included in the patient interview to be used at baseline and follow-up

  4. Change in Dialysis Center or CKD Clinic Staff Perceptions of normalization of the change elements [ Time Frame: Before 2nd learning session (September 2019), before 3rd learning session (March 2020) and after 3rd Action Period (Late 2020) ]
    Staff at each site will complete a validated implementation instrument (NOMAD) measuring normalization of specific elements from the change package.

  5. Change in Dialysis Center or CKD Clinic Staff Perceptions of uptake of change package elements [ Time Frame: Before 2nd learning session (September 2019), before 3rd learning session (March 2020) and after 3rd Action Period (Late 2020) ]
    A second survey measures change in organization-wide staff perception of how well their organization provides supportive care services using a staff survey administered prior to the Collaborative and at the end of the Collaborative. The measurement instrument is a staff survey, the Kidney Supportive Care Implementation Quotient (KSC-IQ), developed by the Pathways team. The KSC-IQ assesses perceived implementation of each change concept in the change package


Other Outcome Measures:
  1. Utilization measures: Palliative Dialysis [ Time Frame: Measured monthly for 18 months. ]
    Utilization measures monitored for exploratory purposes include patients using palliative dialysis

  2. Utilization measures: patients withdrawing from dialysis [ Time Frame: Measured monthly for 18 months. ]
    Utilization measures monitored for exploratory purposes include patients patients withdrawing from dialysis

  3. Utilization measures: emergency department visits [ Time Frame: Measured monthly for 18 months. ]
    Utilization measures monitored for exploratory purposes include patients visiting emergency departments

  4. Utilization measures: hospitalizations [ Time Frame: Measured monthly for 18 months. ]
    Utilization measures monitored for exploratory purposes include patients hospitalized

  5. Utilization measures: hospice admissions [ Time Frame: Measured monthly for 18 months. ]
    Utilization measures monitored for exploratory purposes include patients admitted to hospice



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population of subjects will include dialysis patients who were determined to be seriously ill according to the "surprise question" screening tool. (360 at baseline and 360 at the end of the study 18 months later. This includes about 20 patients for pre-testing the survey.) Facility-level monthly report: One report per dialysis center or CKD practice will be obtained monthly. Reports cover all patients at the site, but data only reported in aggregate.

Patient level demographic/utilization information. This is collected on all patients who are identified as seriously ill (usually 20% of patients). We expect 300 patients to be identified at baseline (20% of the 1500 total patients).

Criteria

Inclusion Criteria:

  • Criteria

    1. Patients at least 18 years old who are currently being treated by participating dialysis center.
    2. Dialysis patients identified as "seriously ill" by screening with "surprise question"- a validated tool that identifies patients with elevated mortality risk. The treating nephrologist or nurse practitioner or dialysis nurse answers whether they would be surprised if the patient died in the next 6 months.

Exclusion Criteria:

  1. Patients with impaired cognitive decision making processes as determined by a screening tool.
  2. Patients who speak language other than English or Spanish.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125537


Locations
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United States, Colorado
Kidney Center of Arvada
Arvada, Colorado, United States, 80002
Thornton Kidney Center
Thornton, Colorado, United States, 80229
Kidney Center of Westminster
Westminster, Colorado, United States, 80031
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052
Washington DC VA Medical Center
Washington, District of Columbia, United States, 20422
United States, New York
Atlantic Dialysis Astoria
Astoria, New York, United States, 11106
Rogosin Institute Auburndale
Flushing, New York, United States, 11358
Atlantic Dialysis Newton
Long Island City, New York, United States, 11102
Rogosin Institute Manhattan East
New York, New York, United States, 10021
Atlantic Dialysis Ridgewood
Ridge, New York, United States, 11385
Rogosin Institute Woodside
Woodside, New York, United States, 11377
United States, Texas
Dallas Nephrology Associates
Dallas, Texas, United States, 75204
Desoto Regional Dialysis Center
DeSoto, Texas, United States, 75115
Sponsors and Collaborators
George Washington University
West Virginia University Research Corporation
Gordon and Betty Moore Foundation
Coalition for Supportive Care of Kidney Patients
Stanford University
Investigators
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Principal Investigator: Dale E Lupu, PhD, MPH The George Washington University
Principal Investigator: Alvin Moss, MD West Virginia University
Additional Information:
Publications:
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Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT04125537    
Other Study ID Numbers: 180679
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by George Washington University:
Shared-Decision Making
Supportive Kidney Care
Goals of Care Conversations
Palliative Care
Palliative Medicine
Advanced Care Planning
Medical Management without Dialysis
Palliative Dialysis
Conservative Kidney Management
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency