Kidney Disease
Conditions
Keywords
Kidney Transplant, African Americans
Brief summary
Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of education, behavior, and financial support interventions to improve consideration of live kidney transplantation/live kidney donation among African Americans on the deceased kidney waiting list. We hypothesize that interventions to help potential kidney transplant recipients and their potential donors overcome barriers to live donor kidney transplant (including family discussions, financial, or logistical barriers) could improve potential recipients' receipt of live kidney transplants. The main outcomes of TALKS will include whether potential recipients (1) have potential live donors call into the transplant center on their behalf; (2) have potential donors evaluated for transplant; or (3) receive a live donor kidney transplant.
Detailed description
Live donor kidney transplantation (LDKT) represents an optimal therapy for many patients. However, African Americans have been persistently and significantly less likely to receive LDKT when compared to Whites. The process of seeking and establishing a live donor for LDKT requires potential donors overcome several potential obstacles to LKDT. As a critical first step to seeking LDKT, patients must engage their physicians and their family members or friends (who provide support for patients' health decisions and could also be potential donors) in discussions about LDKT to determine whether LDKT is a viable and/or desirable treatment option. LDKT discussions with physicians help patients and family members understand the risks and benefits of LDKT to both the potential recipient and any potential donors. Families' LDKT discussions help them establish whether it is possible to identify willing and medically eligible live donors, and they help families discuss the potential psychological, physical, and financial strains of LDKT on patients and families. Once discussions have occurred, potential donors must confront logistical (e.g., childcare or travel to transplant centers) and financial (e.g., unpaid time away from work) challenges associated with LDKT. Studies have shown that even when African American patients desire LDKT, rates of LDKT discussions are suboptimal. Further, African American potential live kidney donors are less likely than their White counterparts to complete the donor evaluation process, and they may be more sensitive than Whites to logistical and financial barriers to LDKT. Innovative strategies to overcome interpersonal, logistical and financial barriers to LDKT are sorely needed for African Americans, particularly those who may be highly motivated to seek this therapy. Transplant social workers routinely perform psychosocial evaluations on potential LDKT recipients and donors and are well suited to support families' navigation of LDKT discussions. Transplant social workers are also well versed in the financial aspects of LDKT (e.g., insurance coverage rules) and frequently provide financial guidance to potential LDKT recipients and donors. We will study innovative transplant social worker led interventions designed to help African American potential LDKT recipients and their families overcome interpersonal, logistical and financial barriers to LDKT. African Americans on the deceased kidney donor waiting list will be randomly assigned to (1) receive their usual care on the transplant list or (2) to one of two social worker led interventions-one which helps patients and families discuss LDKT with each other and with patients' physicians, and one which provides families with financial support to overcome logistical and financial barriers to LDKT. As a primary outcome, we will measure whether the interventions activate live kidney donation on African American potential recipients' behalf.
Interventions
TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
The financial assistance intervention offers potential donors the ability to draw from a bank of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating.
Sponsors
Study design
Eligibility
Inclusion criteria
For potential kidney transplant recipients (all arms): Inclusion Criteria: * Adult (18 yrs or older) * African American * Duke Kidney and Pancreas Transplant patients with end stage kidney disease * Currently on the deceased donor kidney waiting list from the Duke Kidney and Pancreas Transplant Program * Give consent to participate
Exclusion criteria
* Previous kidney transplant (Revised Sept 2016: persons who have previously received a deceased donor kidney transplant, but who have not previously received a live donor kidney transplant) * Cognitively impaired/Change in cognition * Impaired hearing or speech * Non-English speaking For family members or friends of potential kidney transplant recipients (TALK and TALK PLUS arms): Inclusion Criteria: * 18 or older * Come to SWI meeting with patient * Give consent to participate For potential live kidney donors (TALKS PLUS arm only) Inclusion Criteria: * 18 or older * Contact the study * Give consent to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Live Kidney Donor Activation Events | 24 months post randomization | Composite rate of live kidney donor inquiries on behalf of participants, completed live kidney donor transplant evaluations, and live kidney donor transplants in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | 24 months post randomization | Potential kidney recipients' behaviors reflecting their interest and pursuit of live donor kidney transplantation, including: self-reported live donor kidney transplant discussions with physicians, self-reported live donor kidney transplant discussions with family, and identification of a potential live donor. |
| Number of Participants With Live Donor Evaluations | 24 months post randomization | Passive follow up of participants for 2 years to assess completed live kidney donor transplant evaluations in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program. |
| Number of Participants With Live Kidney Donor Transplants | 24 months post randomization | Passive follow up of participants for 2 years to assess live kidney donor transplants in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between September 2015 and May 2017. Participants were recruited from the Duke University Kidney and Pancreas Transplant Center in Durham, North Carolina. Transplant Center electronic health records were used to identify eligible patients.
Pre-assignment details
Family members or friends of potential kidney transplant recipients and potential live kidney donors were not enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual medical care at the Duke Kidney Transplant Clinic | 100 |
| TALKS Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes. | 100 |
| TALKS PLUS Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention
TALKS Social Worker Intervention: TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
Financial Assistance Intervention: The financial assistance intervention offers potential donors the ability to draw from a bank of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating. | 100 |
| Total | 300 |
Baseline characteristics
| Characteristic | Total | Usual Care | TALKS | TALKS PLUS |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 41 Participants | 11 Participants | 17 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 259 Participants | 89 Participants | 83 Participants | 87 Participants |
| Age, Continuous | 52.3 years | 51.7 years | 52.3 years | 52.4 years |
| Current end-stage (ESRD) renal disease treatment Home hemodialysis | 12 Participants | 6 Participants | 3 Participants | 3 Participants |
| Current end-stage (ESRD) renal disease treatment In-center hemodialysis | 189 Participants | 63 Participants | 63 Participants | 63 Participants |
| Current end-stage (ESRD) renal disease treatment No kidney replacement treatment yet | 53 Participants | 15 Participants | 16 Participants | 22 Participants |
| Current end-stage (ESRD) renal disease treatment Peritoneal dialysis | 46 Participants | 16 Participants | 18 Participants | 12 Participants |
| Education College | 65 Participants | 22 Participants | 25 Participants | 18 Participants |
| Education Graduate or professional school | 25 Participants | 10 Participants | 5 Participants | 10 Participants |
| Education High school (9-12) or GED | 113 Participants | 37 Participants | 38 Participants | 38 Participants |
| Education Intermediate or middle school (6-8) | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Education Two years of college | 93 Participants | 30 Participants | 30 Participants | 33 Participants |
| Employment Full-time employee | 59 Participants | 18 Participants | 19 Participants | 22 Participants |
| Employment Homemaker | 8 Participants | 1 Participants | 3 Participants | 4 Participants |
| Employment Part-time employee | 21 Participants | 6 Participants | 10 Participants | 5 Participants |
| Employment Refused | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Employment Retired | 33 Participants | 9 Participants | 14 Participants | 10 Participants |
| Employment Retired due to disability | 151 Participants | 56 Participants | 47 Participants | 48 Participants |
| Employment Student | 5 Participants | 3 Participants | 1 Participants | 1 Participants |
| Employment Unemployed/looking for work | 22 Participants | 6 Participants | 6 Participants | 10 Participants |
| Family history of kidney disease | 152 Participants | 52 Participants | 49 Participants | 51 Participants |
| Family members Father living No | 211 Participants | 65 Participants | 77 Participants | 69 Participants |
| Family members Father living Yes | 89 Participants | 35 Participants | 23 Participants | 31 Participants |
| Family members Has child(ren) No | 60 Participants | 23 Participants | 15 Participants | 22 Participants |
| Family members Has child(ren) Yes | 240 Participants | 77 Participants | 85 Participants | 78 Participants |
| Family members Has sibling(s) No | 32 Participants | 14 Participants | 9 Participants | 9 Participants |
| Family members Has sibling(s) Yes | 268 Participants | 86 Participants | 91 Participants | 91 Participants |
| Family members Mother living No | 152 Participants | 57 Participants | 50 Participants | 45 Participants |
| Family members Mother living Yes | 148 Participants | 43 Participants | 50 Participants | 55 Participants |
| Health literacy ≤3rd grade | 10 Participants | 3 Participants | 3 Participants | 4 Participants |
| Health literacy 4th-6th grade | 13 Participants | 5 Participants | 4 Participants | 4 Participants |
| Health literacy 7th-8th grade | 89 Participants | 27 Participants | 29 Participants | 33 Participants |
| Health literacy ≥9th grade | 177 Participants | 64 Participants | 58 Participants | 55 Participants |
| Health literacy Missing | 11 Participants | 1 Participants | 6 Participants | 4 Participants |
| Income $20,000 - $39,999 | 70 Participants | 21 Participants | 24 Participants | 25 Participants |
| Income $40,000 - $59,999 | 60 Participants | 26 Participants | 14 Participants | 20 Participants |
| Income $60,000 or more | 67 Participants | 22 Participants | 26 Participants | 19 Participants |
| Income Refused/Don't know | 45 Participants | 13 Participants | 18 Participants | 14 Participants |
| Income Under $20,000 | 58 Participants | 18 Participants | 18 Participants | 22 Participants |
| Marital status Divorced | 40 Participants | 18 Participants | 8 Participants | 14 Participants |
| Marital status Married/living with partner | 136 Participants | 48 Participants | 44 Participants | 44 Participants |
| Marital status Separated | 18 Participants | 3 Participants | 7 Participants | 8 Participants |
| Marital status Single, never married | 89 Participants | 27 Participants | 29 Participants | 33 Participants |
| Marital status Widowed | 17 Participants | 4 Participants | 12 Participants | 1 Participants |
| Medical Insurance Medicaid Only | 13 Participants | 5 Participants | 2 Participants | 6 Participants |
| Medical Insurance Medicare/Medicaid | 57 Participants | 14 Participants | 21 Participants | 22 Participants |
| Medical Insurance Medicare Only | 158 Participants | 57 Participants | 53 Participants | 48 Participants |
| Medical Insurance Other | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Medical Insurance Private | 68 Participants | 22 Participants | 23 Participants | 23 Participants |
| Poverty Missing | 45 Participants | 13 Participants | 18 Participants | 14 Participants |
| Poverty Near poverty | 24 Participants | 7 Participants | 9 Participants | 8 Participants |
| Poverty Not in poverty | 202 Participants | 70 Participants | 65 Participants | 67 Participants |
| Poverty Poverty | 29 Participants | 10 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 300 Participants | 100 Participants | 100 Participants | 100 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 300 Participants | 100 Participants | 100 Participants | 100 Participants |
| Sex: Female, Male Female | 133 Participants | 41 Participants | 46 Participants | 46 Participants |
| Sex: Female, Male Male | 167 Participants | 59 Participants | 54 Participants | 54 Participants |
| Total potential immediate family donors | 6 potential immediate family donors | 6 potential immediate family donors | 6 potential immediate family donors | 5.5 potential immediate family donors |
| Years on the waiting list | 0.8 years | 0.5 years | 0.8 years | 0.9 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 | 0 / 100 |
Outcome results
Number of Participants With Live Kidney Donor Activation Events
Composite rate of live kidney donor inquiries on behalf of participants, completed live kidney donor transplant evaluations, and live kidney donor transplants in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program.
Time frame: 24 months post randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Live Kidney Donor Activation Events | 0 Activation events | 87 Participants |
| Usual Care | Number of Participants With Live Kidney Donor Activation Events | 1 Activation event | 5 Participants |
| Usual Care | Number of Participants With Live Kidney Donor Activation Events | 2 Activation events | 3 Participants |
| Usual Care | Number of Participants With Live Kidney Donor Activation Events | 3 Activation events | 3 Participants |
| Usual Care | Number of Participants With Live Kidney Donor Activation Events | 4 Activation events | 1 Participants |
| Usual Care | Number of Participants With Live Kidney Donor Activation Events | >=5 Activation events | 1 Participants |
| TALKS | Number of Participants With Live Kidney Donor Activation Events | >=5 Activation events | 0 Participants |
| TALKS | Number of Participants With Live Kidney Donor Activation Events | 0 Activation events | 86 Participants |
| TALKS | Number of Participants With Live Kidney Donor Activation Events | 3 Activation events | 2 Participants |
| TALKS | Number of Participants With Live Kidney Donor Activation Events | 4 Activation events | 1 Participants |
| TALKS | Number of Participants With Live Kidney Donor Activation Events | 1 Activation event | 4 Participants |
| TALKS | Number of Participants With Live Kidney Donor Activation Events | 2 Activation events | 7 Participants |
| TALKS PLUS | Number of Participants With Live Kidney Donor Activation Events | 1 Activation event | 7 Participants |
| TALKS PLUS | Number of Participants With Live Kidney Donor Activation Events | 2 Activation events | 2 Participants |
| TALKS PLUS | Number of Participants With Live Kidney Donor Activation Events | >=5 Activation events | 0 Participants |
| TALKS PLUS | Number of Participants With Live Kidney Donor Activation Events | 3 Activation events | 3 Participants |
| TALKS PLUS | Number of Participants With Live Kidney Donor Activation Events | 0 Activation events | 88 Participants |
| TALKS PLUS | Number of Participants With Live Kidney Donor Activation Events | 4 Activation events | 0 Participants |
Number of Participants With Live Donor Evaluations
Passive follow up of participants for 2 years to assess completed live kidney donor transplant evaluations in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program.
Time frame: 24 months post randomization
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Live Donor Evaluations | 3 Evaluations | 0 Participants |
| Usual Care | Number of Participants With Live Donor Evaluations | 2 Evaluations | 2 Participants |
| Usual Care | Number of Participants With Live Donor Evaluations | 0 Evaluations | 93 Participants |
| Usual Care | Number of Participants With Live Donor Evaluations | 1 Evaluation | 5 Participants |
| Usual Care | Number of Participants With Live Donor Evaluations | 4 Evaluations | 0 Participants |
| TALKS | Number of Participants With Live Donor Evaluations | 2 Evaluations | 0 Participants |
| TALKS | Number of Participants With Live Donor Evaluations | 0 Evaluations | 93 Participants |
| TALKS | Number of Participants With Live Donor Evaluations | 1 Evaluation | 7 Participants |
| TALKS | Number of Participants With Live Donor Evaluations | 3 Evaluations | 0 Participants |
| TALKS | Number of Participants With Live Donor Evaluations | 4 Evaluations | 0 Participants |
| TALKS PLUS | Number of Participants With Live Donor Evaluations | 4 Evaluations | 0 Participants |
| TALKS PLUS | Number of Participants With Live Donor Evaluations | 3 Evaluations | 0 Participants |
| TALKS PLUS | Number of Participants With Live Donor Evaluations | 0 Evaluations | 97 Participants |
| TALKS PLUS | Number of Participants With Live Donor Evaluations | 2 Evaluations | 0 Participants |
| TALKS PLUS | Number of Participants With Live Donor Evaluations | 1 Evaluation | 3 Participants |
Number of Participants With Live Kidney Donor Transplants
Passive follow up of participants for 2 years to assess live kidney donor transplants in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program.
Time frame: 24 months post randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Live Kidney Donor Transplants | 2 Participants |
| TALKS | Number of Participants With Live Kidney Donor Transplants | 1 Participants |
| TALKS PLUS | Number of Participants With Live Kidney Donor Transplants | 2 Participants |
Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation
Potential kidney recipients' behaviors reflecting their interest and pursuit of live donor kidney transplantation, including: self-reported live donor kidney transplant discussions with physicians, self-reported live donor kidney transplant discussions with family, and identification of a potential live donor.
Time frame: 24 months post randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | Low pursuit (did not discuss with family) | 1 Participants |
| Usual Care | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | Moderate (Discussed with family) | 12 Participants |
| Usual Care | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | High (Identified potential donor) | 58 Participants |
| Usual Care | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | Data missing | 29 Participants |
| TALKS | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | Data missing | 33 Participants |
| TALKS | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | Low pursuit (did not discuss with family) | 0 Participants |
| TALKS | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | High (Identified potential donor) | 57 Participants |
| TALKS | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | Moderate (Discussed with family) | 10 Participants |
| TALKS PLUS | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | Data missing | 27 Participants |
| TALKS PLUS | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | Moderate (Discussed with family) | 8 Participants |
| TALKS PLUS | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | High (Identified potential donor) | 64 Participants |
| TALKS PLUS | Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation | Low pursuit (did not discuss with family) | 1 Participants |