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OpenTrials
Completed

NCT Number: NCT05879302

Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision

The goal of this pilot randomized trial is to learn about shared decision making in kidney transplant candidates. The aim of this proposal is to evaluate the Donor Plan Donor Choice tool to promote high-quality Shared Decision Making for providers and kidney transplant candidates at two transplant centers.

Participants will:

* Review an online education tool, Donor Plan Donor Choice. * Discuss a Kidney Offer Plan with a transplant provider. * Answer questions about willingness to consider different donor types.

Researchers will compare the Shared Decision Making group to usual care to generate pilot data and implementation outcomes for a larger trial.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes ESRD End-stage Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Kidney Transplantation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin Healthcare, Minneapolis, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidate on the kidney transplant waiting list
  • Greater than 3 months since listing for transplant
  • 18 Years of age or older
  • English-speaking

Exclusion criteria

  • Non-English speaking
  • < 18 years of age
  • Patients who choose to opt out of research.
  • Unable to provide informed consent

Treatment and study plan

Kidney Offer Shared Decision Making

Behavioral

The intervention consists of receiving the Donor Offer Plan (DOP), reviewing a web-based educational module about donor offers including practice offer videos, followed by a discussion about the DOP with a transplant nurse coordinator.

Primary outcomes

  1. Willingness to accept donor organs at risk of discard

    Time frame: Up to 2 months

    Willingness to accept a donor kidney offer will be measured by three items on a 5-point Likert scale anchored by "strongly agree" and "strongly disagree." Willingness to accept will be defined by answers of "agree" or "strongly agree."

Secondary outcomes

  1. Knowledge

    Time frame: Up to 2 months

    10 Knowledge questions relating to organ offers and organ quality

  2. Decisional Conflict

    Time frame: Up to 2 months

    16 Decisional Conflict questions (Ottawa scale)

  3. Distress

    Time frame: Up to 2 months

    5 STOP-D (Screening Tool for Psychological Distress) questions

  4. Shared Decision Making

    Time frame: Up to 2 months

    9 items of the SDMQ9 for Shared Decision Making

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • Mayo Clinic
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 30, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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