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

Enrolling by invitation · Not applicable

Conditions studied: Chronic Kidney Disease

In brief

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, and palliative dialysis. 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 14 chronic kidney disease clinics at 7 practice organizations around the United States. Aim 1: Compare the effectiveness of Approaches 1 and 2 in increasing proportion of patients choosing ATP and explore comparative effectiveness on patient reported outcomes of decisional conflict and shared decision-making as well as health care utilization and advance care planning. 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, surveys, and interviews with patients and care partners. For Aim 3, clinic administrators, clinical providers, and staff will complete pre- and post-test surveys at the beginning and end of each training.

Key facts

Study ID

NCT06243068

Run by

George Washington University

People needed

3000

Starts

2024-11-13

Expected to finish

2028-12-31

Last updated by the study team

2026-06-11

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 65 years or older
• Most recent eGFR <30 at time of screening AND meets practice site criteria for KDE referral
• Treatment naïve (no dialysis or kidney transplant prior to enrollment)

You may not qualify if…

• The current decrease in eGFR is thought to be due to an acute event.
• Education and initiation of shared decision-making process are not yet indicated for the patient, (per practice protocol and/or provider's judgment).
• Exclusion Criteria for surveys and interviews:
• Insufficient decision-making capacity
• Non-English and non-Spanish speaking
• Treating nephrologist/APP opts patient out (for example, if contraindicated for patient's health)
• Study Population 2: Family member or care partner of patient in Study Population 1
• Inclusion Criteria:
• Family member or care partner of Population 1 patient who has chosen active medical care without dialysis and consented to decisional conflict surveys
• 18+ years old
• English or Spanish speaking
• Cognitively able to participate in surveys/interviews
• Study Population 3: Administrator, clinical provider, or staff at participating chronic kidney disease clinic
• Inclusion Criteria:
• Currently practicing or employed at participating clinic

Where it is running

• UCSF/Zuckerberg San Francisco General Hospital and Trauma Center-Nephrology — San Francisco, California, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Southeast Kidney Associates — Canton, Georgia, United States
• Southeast Kidney Associates — East Point, Georgia, United States
• St. Clair Nephrology — Shelby, Michigan, United States
• The Rogosin Institute Manhattan Eat Dialysis — New York, New York, United States
• Clinical Renal Associates — Exton, Pennsylvania, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• Renal Disease Research Institute — Dallas, Texas, United States
• Renal Disease Research Institute — Fort Worth, Texas, United States
• Renal Disease Research Institute — Garland, Texas, United States
• Renal Disease Research Institute — Irving, Texas, United States
• North Texas Kidney Disease Associates — Lewisville, Texas, United States
• Renal Disease Research Institute — McKinney, Texas, United States
• Renal Disease Research Institute — McKinney, Texas, United States
• Renal Disease Research Institute — Mesquite, Texas, United States
• North Texas Kidney Disease Associates — North Richland Hills, Texas, United States
• North Texas Kidney Disease Associates — Plano, Texas, United States
• Renal Disease Research Institute — Plano, Texas, United States
• Virginia Nephrology Group — Alexandria, Virginia, United States
• Virginia Nephrology Group — Arlington, Virginia, United States
• Virginia Nephrology Group — Fairfax, Virginia, United States
• West Virginia University Medicine — Fairmont, West Virginia, United States
• West Virginia University Medicine — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.