NCT04125537

Pathways Project: Kidney Supportive Care

Completed Last updated 13 September 2023

What this trial tests

trial testing IHI Breakthrough Collaborative Model in Kidney Diseases in 476 participants. Completed in 31 October 2020.

Timeline

1 November 2018

Primary endpoint
31 August 2020

31 October 2020

Quick facts

Lead sponsor	George Washington University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	476
Start date	1 November 2018
Primary completion	31 August 2020
Estimated completion	31 October 2020
Sites	13 locations across United States

Drugs / interventions tested

• IHI Breakthrough Collaborative Model

Conditions studied

• Kidney Diseases — all drugs for Kidney Diseases →
• Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
• End Stage Renal Disease — all drugs for End Stage Renal Disease →
• End Stage Renal Disease on Dialysis — all drugs for End Stage Renal Disease on Dialysis →

Sponsor

George Washington University

Who can join

18 and older, any sex, with Kidney Diseases or Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implementation and Effectiveness of a Learning Collaborative to Improve Palliative Care for Seriously Ill Hemodialysis Patients.
   Kurella Tamura M, Holdsworth L, Stedman M, Aldous A, et al · · 2022 · cited 11× · PMID 36104084 · DOI 10.2215/cjn.00090122
2. Pathways Project: Development of a Multimodal Innovation To Improve Kidney Supportive Care in Dialysis Centers.
   Lupu DE, Aldous A, Harbert G, Kurella Tamura M, et al · · 2021 · cited 8× · PMID 35368811 · DOI 10.34067/kid.0005892020
3. Pathways Project Pragmatic Lessons Learned: Integrating Supportive Care Best Practices into Real-World Kidney Care.
   Moss AH, Harbert G, Aldous A, Anderson E, et al · · 2023 · cited 4× · PMID 37889550 · DOI 10.34067/kid.0000000000000277
4. "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.
   Holdsworth LM, Stedman M, Gustafsson ES, Han J, et al · · 2023 · cited 2× · PMID 38082293 · DOI 10.1186/s12913-023-10360-7