End Stage Renal DiseaseNCT05879302
Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision
A study testing Kidney Offer Shared Decision Making in people with End Stage Renal Disease and End-Stage Kidney Disease, run by Hennepin Healthcare Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, End-Stage Kidney Disease, Kidney Transplantation
- What is being tested?
- Kidney Offer Shared Decision Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Apr 2024to 17 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate on the kidney transplant waiting list
- Greater than 3 months since listing for transplant
- 18 Years of age or older
- English-speaking
Who cannot join
- Non-English speaking
- < 18 years of age
- Patients who choose to opt out of research.
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hennepin Healthcare
Minneapolis, Minnesota, 55415
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
- Being tested
- Kidney Offer Shared Decision Making
- Keywords
- Shared Decision Making, SDM, Transplantation, Organ offer, Kidney offer, KDPI
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney Offer Shared Decision MakingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making Intervention | Experimental | Receives the Shared Decision Making Intervention Receives: Behavioral: Kidney Offer Shared Decision Making |
| Usual Care | No intervention | Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Up to 2 months
Secondary outcomes (4)
Knowledge
10 Knowledge questions relating to organ offers and organ quality
Measured: Up to 2 months
Decisional Conflict
16 Decisional Conflict questions (Ottawa scale)
Measured: Up to 2 months
Distress
5 STOP-D (Screening Tool for Psychological Distress) questions
Measured: Up to 2 months
Shared Decision Making
9 items of the SDMQ9 for Shared Decision Making
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start3 Apr 2024
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cory Schaffhausen, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879302
- Sponsor's protocol ID
- Pro00067603
- Other IDs
- 1R01DK134482
- Status last verified
- Apr 2026
- First submitted
- 17 May 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision
- ClinicalTrials.gov ID
- NCT05879302
- Acronym / sponsor ID
- Pro00067603
- Keywords
- Shared Decision Making, SDM, Transplantation, Organ offer, Kidney offer, KDPI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making Intervention | Experimental | Behavioral: Kidney Offer Shared Decision MakingReceives the Shared Decision Making Intervention |
| Usual Care | No intervention | –Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidate on the kidney transplant waiting list
- Greater than 3 months since listing for transplant
- 18 Years of age or older
- English-speaking
Key exclusion criteria (4 listed)
- Non-English speaking
- < 18 years of age
- Patients who choose to opt out of research.
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney Offer Shared Decision MakingThe 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. | Behavioural | Shared Decision Making Intervention |
Primary outcome
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."
4 secondary outcomes
Knowledge
Time frame: Up to 2 months
Decisional Conflict
Time frame: Up to 2 months
Distress
Time frame: Up to 2 months
Shared Decision Making
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney Offer Shared Decision Making in people with End Stage Renal Disease and End-Stage Kidney Disease, run by Hennepin Healthcare Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to accept donor organs at risk of discard (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.