search
Back to results

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

Primary Purpose

End Stage Renal Disease, End-Stage Kidney Disease, Kidney Transplantation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kidney Offer Shared Decision Making
Sponsored by
Hennepin Healthcare Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for End Stage Renal Disease focused on measuring Shared Decision Making, SDM, Transplantation, Organ offer, Kidney offer, KDPI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hennepin Healthcare
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Shared Decision Making Intervention

Usual Care

Arm Description

Receives the Shared Decision Making Intervention

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

Outcomes

Primary Outcome Measures

Willingness to accept donor organs at risk of discard
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 Outcome Measures

Knowledge
10 Knowledge questions relating to organ offers and organ quality
Decisional Conflict
16 Decisional Conflict questions (Ottawa scale)
Distress
5 STOP-D (Screening Tool for Psychological Distress) questions
Shared Decision Making
9 items of the SDMQ9 for Shared Decision Making

Full Information

First Posted
May 17, 2023
Last Updated
May 25, 2023
Sponsor
Hennepin Healthcare Research Institute
Collaborators
Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT05879302
Brief Title
Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision
Official Title
Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hennepin Healthcare Research Institute
Collaborators
Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, End-Stage Kidney Disease, Kidney Transplantation, Esrd
Keywords
Shared Decision Making, SDM, Transplantation, Organ offer, Kidney offer, KDPI

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
All study personnel involved in screening and enrollment will be masked to upcoming randomization assignments
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shared Decision Making Intervention
Arm Type
Experimental
Arm Description
Receives the Shared Decision Making Intervention
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates.
Intervention Type
Behavioral
Intervention Name(s)
Kidney Offer Shared Decision Making
Intervention Description
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 Outcome Measure Information:
Title
Willingness to accept donor organs at risk of discard
Description
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."
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Knowledge
Description
10 Knowledge questions relating to organ offers and organ quality
Time Frame
Up to 2 months
Title
Decisional Conflict
Description
16 Decisional Conflict questions (Ottawa scale)
Time Frame
Up to 2 months
Title
Distress
Description
5 STOP-D (Screening Tool for Psychological Distress) questions
Time Frame
Up to 2 months
Title
Shared Decision Making
Description
9 items of the SDMQ9 for Shared Decision Making
Time Frame
Up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cory Schaffhausen
Phone
(612) 873-5300
Email
schaf390@umn.edu
Facility Information:
Facility Name
Hennepin Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cory Schaffhausen
Phone
612-873-5300
Email
schaf390@umn.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kasey Boehmer
Phone
507-422-5538
Email
Boehmer.Kasey@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs