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Pathways Project Collaborative Phase II: Implementation of Kidney Supportive Care in Practice
Sponsor study identifier
observational
476
1 country
13
Study Start
November 1, 2018
Actual (reported)Primary Completion
August 31, 2020
Actual (reported)Study Completion
October 31, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2018
Actual (reported)August 5, 2019
Actual (reported)October 14, 2019
Actual (reported)August 31, 2020
Actual (reported)October 31, 2020
Actual (reported)Change in Patient Reported Quality of Communication
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.
[Time Frame: Baseline (June 2019); Post Intervention- After 3rd Action Period (Late 2020)]
Change in Comprehensive advance care planning documentation
The comprehensiveness of advance care planning as documented in dialysis center or CKD clinic chart
[Time Frame: Baseline (June 2019); Post Intervention- After 3rd Action Period (Late 2020)]
Change in Patient reported Outcome Measure: Advance Care Planning Engagement
Dialysis center patients who screened positive as seriously ill in month 1 of the collaborative activities (the preimplementation period).
Dialysis Center patients who screened positive as seriously ill in month 15 of the intervention (the post-implementation period).
Staff teams at participating dialysis centers take part in a quality improvement/collaborative learning model that was initially planned to include three in-person learning sessions, and three activity sessions during which staff teams at each site use quality improvement processes to implement kidney supportive care best practices from the change package. Technical assistance, education, and quality improvement coaching are provided to the site staff teams throughout the project. Patients at the sites then receive care that has been improved via this staff education and quality improvement activities.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
Kidney Center of Arvada
Arvada, Colorado, 80002, United States
Thornton Kidney Center
Thornton, Colorado, 80229, United States
Kidney Center of Westminster
Westminster, Colorado, 80031, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422, United States
Atlantic Dialysis Astoria
Astoria, New York, 11106, United States
Rogosin Institute Auburndale
Flushing, New York, 11358, United States
Lupu DE, Aldous A, Harbert G, Kurella Tamura M, Holdsworth LM, Nicklas A, Vinson B, Moss AH. Pathways Project: Development of a Multimodal Innovation To Improve Kidney Supportive Care in Dialysis Centers. Kidney360. 2020 Nov 23;2(1):114-128. doi: 10.34067/KID.0005892020. eCollection 2021 Jan 28.
Kurella Tamura M, Holdsworth L, Stedman M, Aldous A, Asch SM, Han J, Harbert G, Lorenz KA, Malcolm E, Nicklas A, Moss AH, Lupu DE. Implementation and Effectiveness of a Learning Collaborative to Improve Palliative Care for Seriously Ill Hemodialysis Patients. Clin J Am Soc Nephrol. 2022 Oct;17(10):1495-1505. doi: 10.2215/CJN.00090122. Epub 2022 Sep 14.
Dale E Lupu, PhD, MPH
The George Washington University
Alvin Moss, MD
West Virginia University
476 participants (actual enrollment reported by the registry).
First Submitted
August 5, 2019
First Posted
October 14, 2019
Study Start
November 1, 2018
Actual (reported)Baseline (June 2019) and after 3rd Action period (late 2020)
Change in Patient Perception of Shared-Decision making
Baseline (June 2019) and after 3rd Action period (late 2020)
Change in patient reported outcome about communication about end-of-life
Baseline (June 2019) and after 3rd Action period (late 2020)
Change in Dialysis Center or CKD Clinic Staff Perceptions of normalization of the change elements
Before 2nd learning session (September 2019), before 3rd learning session (March 2020) and after 3rd Action Period (Late 2020)
Change in Dialysis Center or CKD Clinic Staff Perceptions of uptake of change package elements
Before 2nd learning session (September 2019), before 3rd learning session (March 2020) and after 3rd Action Period (Late 2020)
Utilization measures: Palliative Dialysis
Measured monthly for 18 months.
Utilization measures: patients withdrawing from dialysis
Measured monthly for 18 months.
Utilization measures: emergency department visits
Measured monthly for 18 months.
Contact the study team to confirm eligibility.
Atlantic Dialysis Newton
Long Island City, New York, 11102, United States
Rogosin Institute Manhattan East
New York, New York, 10021, United States
Atlantic Dialysis Ridgewood
Ridge, New York, 11385, United States
Rogosin Institute Woodside
Woodside, New York, 11377, United States
Dallas Nephrology Associates
Dallas, Texas, 75204, United States
Desoto Regional Dialysis Center
DeSoto, Texas, 75115, United States
Holdsworth LM, Stedman M, Gustafsson ES, Han J, Asch SM, Harbert G, Lorenz KA, Lupu DE, Malcolm E, Moss AH, Nicklas A, Kurella Tamura M. "Diving in the deep-end and swimming": a mixed methods study using normalization process theory to evaluate a learning collaborative approach for the implementation of palliative care practices in hemodialysis centers. BMC Health Serv Res. 2023 Dec 11;23(1):1384. doi: 10.1186/s12913-023-10360-7.
Moss AH, Harbert G, Aldous A, Anderson E, Nicklas A, Lupu DE. Pathways Project Pragmatic Lessons Learned: Integrating Supportive Care Best Practices into Real-World Kidney Care. Kidney360. 2023 Dec 1;4(12):1738-1751. doi: 10.34067/KID.0000000000000277. Epub 2023 Oct 27.
Primary Completion
August 31, 2020
Actual (reported)Study Completion
October 31, 2020
Actual (reported)Last Updated
September 13, 2023
Record last verified: 2023-09
No plan to share IPD
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Source: ClinicalTrials.gov.
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