Expanding and Promoting Alternative Care and kNowledge in Decision-making Trial - Trial NCT06243068

Timeline & Enrollment

Primary Outcome

Proportion of patients choosing Alternative Treatment Plans (ATP),Decisional Conflict Scale score

Summary

The goal of this clinical trial is to compare two health system-based approaches for offering
 kidney failure treatment options to older patients with kidney failure, specifically, to
 ensure patients are actively involved in a shared decision making (SDM) process covering a
 full range of treatment choices and have meaningful access to that full range of choices.
 These include standard in-center or home dialysis as well as alternative treatment plans
 (ATPs): active medical care without dialysis, time-limited trial of dialysis, palliative
 dialysis, and deciding not to decide.
 
 Approach 1 - Educate and Engage:
 
 Nephrology practices encourage their patients to a) participate in a kidney disease education
 program providing a balanced presentation of all options including ATPs, b) use
 evidence-based patient decision aids that include ATPs, and c) engage in SDM with staff
 trained in communication skills and best practices.
 
 Approach 2 - Educate and Engage Plus Kidney Supportive Care Program:
 
 Nephrology practices add a primary palliative care program to support patients who choose
 ATPs and their families. The program provides care coordination, symptom management, advance
 care planning, and psychosocial support to supplement usual care from their nephrologist.
 
 To compare the two approaches, the investigators will conduct a repeated, cross-sectional
 stepped wedge cluster randomized trial involving 28 chronic kidney disease clinics at 10
 practice organizations around the United States.
 
 Aim 1: Compare the effectiveness of Approaches 1 and 2 in a) increasing proportion of
 patients choosing ATP and b) reducing patient-reported decisional conflict about treatment.
 
 Aim 2: Compare the patient and family experience of ATP care between Approaches 1 and 2 in
 terms of quality of life, services used, and end of life (EOL) experience. Aim 2a will focus
 on experience while patients are receiving an ATP. Aim 2b will describe the EOL experience.
 
 Aim 3: Evaluate implementation of each approach through a mixed-methods design based on the
 expanded RE-AIM framework.
 
 For Aims 1 and 2, researchers will collect information by chart review and surveys with
 patients and caregivers. For Aim 3, information will be reported by site managers as part of
 monthly progress reports. Clinic administrators, clinical providers, and staff will complete
 surveys before and after implementation of each approach.

ICD-10 Classifications