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| Name | Class |
|---|---|
| Kidney Transplant Collaborative | UNKNOWN |
| National Kidney Foundation, United States | OTHER |
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The goal of this clinical trial is to increase shared decision-making between dialysis providers and patients in order to increase patients' probability of transplantation and to reduce socioeconomic/racial disparities in access to kidney transplantation.
Participants will receive educational material over the course of 4-6 months about different aspects of the kidney transplant and waitlisting process.
Kidney transplantation is the preferred treatment choice for patients with end stage kidney disease (ESKD), yet only a small proportion of patients with incident ESKD are counseled about their transplant options. Often, a smaller minority of patients reach the transplant waitlist in a timely manner. Increasing the likelihood of transplantation for patients with ESKD can lead to longer survival, better quality of life, and reduced costs of care.
The kidney transplant and waitlist process is a complex and multi-step process that occurs over an extended period of time. This process involves transitions of care between multiple providers and requires patients to be proactive in their medical evaluations.
This study will deliver educational materials to dialysis care teams and provide quarterly, personalized informational letters to patients, with the aim of increasing shared decision-making between patients and providers by giving them the information needed to initiate conversations about kidney transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Providers | Experimental | Dialysis providers will receive educational material about the kidney transplantation and waitlisting process. |
|
| Patients | Experimental | Dialysis patients will receive letters with information about their status within the kidney transplantation and waitlisting process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provider educational materials | Behavioral | Dialysis providers will receive educational material about the kidney transplantation and waitlisting process. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient knowledge of individual waitlist status | Patient knowledge of individual waitlist status will be measured by one Yes/No question on the patient survey using McNemar's test. | Baseline (day 1), post letter 1 (approx 1 month later), post letter 2 (approx 1 month later), post letter 3 (approx 1 month later), post intervention (approx 4-6 months total) |
| Change in frequency of shared decision-making conversations, | Frequency of shared decision-making conversations will be measured by two Yes/No questions on the patient survey using McNemar's test. | Baseline (day 1), post letter 1 (approx 1 month later), post letter 2 (approx 1 month later), post letter 3 ( approx 1 month later), post intervention (approx 4-6 mos total) |
| Change in donor kidney preferences | Patient preferences for kidneys from living donors, kidneys from Hepatitis C positive donors, and kidneys from high KDPI donors will be measured by six Yes/No questions on the patient survey using McNemar's test. | Baseline (day 1), post letter 1 (approx 1 month later), post letter 2 (approx 1 month later), post letter 3 (approx 1 month later), post intervention (approximately 4-6 mos total) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dialysis provider attitudes, as measured on provider survey | Dialysis providers' attitudes and comfort with discussing the kidney waitlist and transplantation process will be measured on the provider survey. Questions will be scored on a 1-5 Likert scale, with 1 indicating low comfort level and 5 indicating high comfort level. Total scores range from 5-25 with a higher score indicating a better outcome. |
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Inclusion Criteria:
On a waitlist or undergoing an evaluation at the Columbia University/New York Presbyterian Hospital (CU/NYPH) Transplant Center or at the Cleveland Clinic (CC)
Receiving hemodialysis at one of the following dialysis clinics:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sumit Mohan, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States | ||
| Cleveland Clinic |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Enrolled providers and enrolled patients will receive different interventions; outcomes assessed for these two groups will be different.
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| Patient letters | Behavioral | Dialysis patients will receive letters with information about their status within the kidney transplantation and waitlisting process. Letters will describe kidney waitlist status, living donor transplantation, Hepatitis C positive kidney transplants, and high Kidney Donor Profile Index (KDPI) transplants. |
|
| Post-educational session, Day 1 |
| Provider assessment of patient letters, as measured on provider survey | Providers' assessment of the helpfulness of patient letters will be measured by five questions on the provider survey. Questions will be scored on a 1-5 Likert scale, with 1 indicating low helpfulness and 5 indicating high helpfulness. Total scores range from 5-25 with a higher score indicating a better outcome. | End of intervention/at completion of letter delivery (4-6 months) |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| 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 |