Pathways Project: Kidney Supportive Care

NCT04125537 | Completed

• 1 other identifier: 180679
• Study Type: observational
• Target: 476
• Locations: 1 country
• Sites: 13

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.

Conditions

Kidney Diseases; Chronic Kidney Diseases; End Stage Renal Disease; End Stage Renal Disease on Dialysis; Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)]

Secondary Outcomes (5)

• Change in Patient reported Outcome Measure: Advance Care Planning Engagement

  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)

Other Outcomes (5)

• 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.

Study Arms (2)

Dialysis Centers - Seriously Ill patients - pre-implementation cohort

Dialysis center patients who screened positive as seriously ill in month 1 of the collaborative activities (the preimplementation period).

Dialysis Centers - Seriously Ill patients - post-intervention cohort

Dialysis Center patients who screened positive as seriously ill in month 15 of the intervention (the post-implementation period).

Behavioral: IHI Breakthrough Collaborative Model

Interventions

IHI Breakthrough Collaborative Model BEHAVIORAL

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.

Dialysis Centers - Seriously Ill patients - post-intervention cohort

Eligibility Criteria

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

You may qualify if:

• Criteria
• Patients at least 18 years old who are currently being treated by participating dialysis center.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• George Washington University: lead
• West Virginia University Research Corporation: collaborator
• Gordon and Betty Moore Foundation: collaborator
• Coalition for Supportive Care of Kidney Patients: collaborator
• Stanford University: collaborator

Study Sites (13)

Kidney Center of Arvada

Arvada, Colorado, 80002, United States

Location

Thornton Kidney Center

Thornton, Colorado, 80229, United States

Location

Kidney Center of Westminster

Westminster, Colorado, 80031, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Atlantic Dialysis Astoria

Astoria, New York, 11106, United States

Location

Rogosin Institute Auburndale

Flushing, New York, 11358, United States

Location

Atlantic Dialysis Newton

Long Island City, New York, 11102, United States

Location

Rogosin Institute Manhattan East

New York, New York, 10021, United States

Location

Atlantic Dialysis Ridgewood

Ridge, New York, 11385, United States

Location

Rogosin Institute Woodside

Woodside, New York, 11377, United States

Location

Dallas Nephrology Associates

Dallas, Texas, 75204, United States

Location

Desoto Regional Dialysis Center

DeSoto, Texas, 75115, United States

Location

Related Publications (4)

• 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.

  PMID: 35368811 BACKGROUND

• 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.

  PMID: 36104084 RESULT

• 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.

  PMID: 38082293 DERIVED

• 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.

  PMID: 37889550 DERIVED

Related Links

• Pathways Project Website

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Dale E Lupu, PhD, MPH

  The George Washington University

  PRINCIPAL INVESTIGATOR

• Alvin Moss, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: October 14, 2019
• Study Start: November 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: October 31, 2020
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)