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Search / Trial NCT06243068

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

Launched by GEORGE WASHINGTON UNIVERSITY · Jan 26, 2024

Trial Information

Current as of July 22, 2025

Enrolling by invitation

Keywords

Ckd Alternative Treatment Plan Kde Kidney Disease Education Palliative Care Shared Decision Making Active Medical Management Without Dialysis Amcwd Kidney Supportive Care Esrd

ClinConnect Summary

The Expanding and Promoting Alternative Care and kNowledge in Decision-making Trial is studying two different ways to help older patients with chronic kidney disease (CKD) make informed choices about their treatment options. The trial aims to ensure that patients are fully involved in deciding between various treatments, such as in-center or home dialysis and alternative plans that do not involve dialysis. The first approach focuses on educating patients about all their options and encouraging discussions with healthcare staff. The second approach adds a palliative care program, which offers extra support for patients and their families who choose alternative treatment options, including help with managing symptoms and planning for the future.

To take part in this trial, eligible participants must be at least 65 years old, have advanced kidney disease (with a specific kidney function measurement), and have not yet started dialysis or had a kidney transplant. Patients will receive education and support based on one of the two approaches, while researchers will collect feedback through surveys and chart reviews to understand how effective each method is. Family members or caregivers of patients who choose alternative treatment options can also participate. This trial is important because it aims to improve the decision-making experience for patients and their families, ultimately enhancing their quality of life and care.

Gender

ALL

Eligibility criteria

  • Study Population 1: Person with CKD, cared for at participating clinic
  • Inclusion Criteria:
  • 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)
  • Exclusion Criteria:
  • The patient is a transplant candidate.
  • 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 primary analysis:
  • - Insufficient decision making capacity (Outcomes for this group will be described separately.)
  • 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 caregiver of patient in Study Population 1
  • Inclusion Criteria:
  • Family member or caregiver of Population 1 patient who has chosen alternative treatment plan
  • 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

About George Washington University

George Washington University (GWU) is a leading academic institution dedicated to advancing medical research and education. As a clinical trial sponsor, GWU leverages its extensive resources and expertise to facilitate innovative studies that aim to improve healthcare outcomes. The university's commitment to ethical research practices, collaboration with multidisciplinary teams, and engagement with diverse populations underscores its role in addressing critical health challenges. By fostering a rigorous scientific environment, GWU strives to translate research findings into effective clinical applications, ultimately enhancing patient care and contributing to the broader medical community.

Locations

Washington, District Of Columbia, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Morgantown, West Virginia, United States

Dallas, Texas, United States

East Point, Georgia, United States

Peoria, Illinois, United States

Jefferson, Louisiana, United States

Dallas, Texas, United States

Lewisville, Texas, United States

Shelby, Michigan, United States

San Francisco, California, United States

Canton, Georgia, United States

New York, New York, United States

Exton, Pennsylvania, United States

Fort Worth, Texas, United States

Garland, Texas, United States

Irving, Texas, United States

Mckinney, Texas, United States

Mesquite, Texas, United States

North Richland Hills, Texas, United States

Plano, Texas, United States

Plano, Texas, United States

Alexandria, Virginia, United States

Arlington, Virginia, United States

Fairfax, Virginia, United States

Fairmont, West Virginia, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported