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

Conditions

• Chronic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Educate and Engage — BEHAVIORAL
  Nephrology practices implement a bundle in which they will 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 shared decision-making with staff who have been trained in communication skills and best practices.
• Educate and Engage Plus Kidney Supportive Care Program — BEHAVIORAL
  In addition to bundle described under "Educate and Engage," nephrology practices offer a systematic program integrating primary palliative care to support patients and their families who choose any ATP. The program closely follows patients and their families on ATP with care coordination, symptom management, advance care planning, and psychosocial support to supplement usual care from their nephrologist.

Study Details

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 Dates

Start date

Nov 13, 2024

Status verified

Jun 2026

Primary completion

Jun 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

3,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Educate and Engage
  Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 1.
• Experimental: Educate and Engage Plus Kidney Supportive Care Program
  Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 2.

Primary Outcome Measure

Proportion of patients choosing Alternative Treatment Plans (ATP) [ Time Frame: Month 4 after enrollment. ]

Locations (25)

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