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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK134482 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared Decision Making Intervention | Experimental | Receives the Shared Decision Making Intervention |
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| Usual Care | No Intervention | Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge | 10 Knowledge questions relating to organ offers and organ quality | Up to 2 months |
| Decisional Conflict | 16 Decisional Conflict questions (Ottawa scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare | Minneapolis | Minnesota | 55415 | United States | ||
| Mayo Clinic |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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All study personnel involved in screening and enrollment will be masked to upcoming randomization assignments
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| Up to 2 months |
| Distress | 5 STOP-D (Screening Tool for Psychological Distress) questions | Up to 2 months |
| Shared Decision Making | 9 items of the SDMQ9 for Shared Decision Making | Up to 2 months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |