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

NCT ID: NCT05879302

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Renal Disease End-Stage Kidney Disease Kidney Transplantation Esrd

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
All study personnel involved in screening and enrollment will be masked to upcoming randomization assignments

Study Groups

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Shared Decision Making Intervention

Receives the Shared Decision Making Intervention

Group Type EXPERIMENTAL

Kidney Offer Shared Decision Making

Intervention Type 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.

Usual Care

Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Kidney Offer Shared Decision Making

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Cory Schaffhausen

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hennepin Healthcare

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cory Schaffhausen

Role: CONTACT

(612) 873-5300

Facility Contacts

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Cory Schaffhausen

Role: primary

612-873-5300

Kasey Boehmer

Role: primary

507-422-5538

Other Identifiers

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1R01DK134482

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00067603

Identifier Type: -

Identifier Source: org_study_id

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