End-Stage Kidney Disease, End Stage Renal Disease, Esrd, Kidney Transplantation
Conditions
Keywords
Shared Decision Making, SDM, Transplantation, Organ offer, Kidney offer, KDPI
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.
Interventions
BEHAVIORALKidney 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.
Sponsors
Hennepin Healthcare Research Institute
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
All study personnel involved in screening and enrollment will be masked to upcoming randomization assignments
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Willingness to accept donor organs at risk of discard | 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
| Measure | Time frame | Description |
|---|---|---|
| Knowledge | Up to 2 months | 10 Knowledge questions relating to organ offers and organ quality |
| Decisional Conflict | Up to 2 months | 16 Decisional Conflict questions (Ottawa scale) |
| Distress | Up to 2 months | 5 STOP-D (Screening Tool for Psychological Distress) questions |
| Shared Decision Making | Up to 2 months | 9 items of the SDMQ9 for Shared Decision Making |
Countries
United States
Outcome results
None listed