Kidney Transplant
Conditions
Keywords
end stage renal disease, ESRD, living donor kidney transplantation, LDKT, African American
Brief summary
For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment, and living donor kidney transplantation (LDKT) is preferable. Nevertheless, there are pervasive racial disparities in access to LDKT. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over study period.The long-term objective is to understand the combined effect of a systems-level intervention (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.
Detailed description
For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment. Moreover, living donor kidney transplantation (LDKT) offers numerous advantages such as better kidney quality, increased short- and long-term graft survival, lower rates of acute rejection, and reduced health care cost. Nevertheless, there are pervasive racial disparities in access to LDKT, with white ESRD patients four times more likely to receive a LDKT than African American ESRD patients. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over 12 months from baseline.The long-term objective is to understand the combined effect of a systems-level intervention that enhances communication between dialysis facility and transplant center clinicians (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.
Interventions
BEHAVIORALLiving ACTS website
Living ACTS: About Choices in Transplantation and Sharing video that draws from the Information-Motivation-Behavioral Skills Model of individual level behavior change. A patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching \ 20-minutes of videos from the website)
BEHAVIORALStandard transplant education procedures
Review of a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two \ 10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* All patients referred (from dialysis facility, chronic kidney disease clinic, or self) and scheduled for an evaluation at one of the four study sites within the study time period. * African American or Black * age 18 to 70 years * BMI \< 39 * English-speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With at Least One Inquiry From a Potential Living Donor | Baseline, 12 months | Data collection form that captures potential recipient ID (i.e. study participant), date of living donor inquiry, and donor inquiry ID, will be securely obtained from each transplant center following a 12 month period from enrollment. Data will be collected electronically for all study participants through a secure, HIPAA-compliant data server (QualityNet). The percent of patients with at least one inquiry from a potential living donor among patients who receive Living ACTS will be compared to those who receive a control website with embedded educational video. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge and Understanding of Donation/Transplantation Assessment Score | Baseline, Day 1 immediately post-intervention | Scale includes 13 true/False questions, score ranges from 0 to 13, 0 Min-13 Maximum where higher scores indicate greater knowledge (i.e., participants receive 1 point for each correct answer). |
| Motivation Scale Score to Ask a Family Member to be a Living Donor | Baseline, Day 1 immediately post-intervention | 9-item scale assesses motivation to ask a family member to be a living donor. Potential responses range from 1 to 5, Possible score range from 9 to 45 with higher values indicating stronger agreement with the statement. |
| Confidence in Initiating a Conversation About LDKT | Baseline, Day 1 immediately post-intervention | 10-item behavioral skills scale measures confidence in initiating a conversation about LDKT. Potential responses range from 1 to 5, total possible score range is 10-50, with higher values indicate stronger confidence. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Living ACTS Website In addition to the provision of standard transplant education procedures, a patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching the 20-minute video).
Living ACTS website: Living ACTS: About Choices in Transplantation and Sharing video that draws from the Information-Motivation-Behavioral Skills Model of individual level behavior change. A patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching \
20-minutes of videos from the website)
Standard transplant education procedures: Review of a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two \
10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population. | 224 |
| Standard Transplant Education Procedures Usual Care, which involves the provision of standard transplant education procedures at each transplant center, which entail reviewing a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two 10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.
Standard transplant education procedures: Review of a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two \
10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population. | 192 |
| Total | 416 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Living ACTS Website | Total | Standard Transplant Education Procedures |
|---|---|---|---|
| Age, Continuous | 49.83 years STANDARD_DEVIATION 11.64 | 49.49 years STANDARD_DEVIATION 11.88 | 49.09 years STANDARD_DEVIATION 12.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 223 Participants | 415 Participants | 192 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 224 Participants | 416 Participants | 192 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 224 participants | 416 participants | 192 participants |
| Sex/Gender, Customized Female | 93 Participants | 182 Participants | 89 Participants |
| Sex/Gender, Customized Male | 128 Participants | 230 Participants | 102 Participants |
| Sex/Gender, Customized Prefer not to answer | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 224 | 0 / 192 |
| other Total, other adverse events | 0 / 224 | 0 / 192 |
| serious Total, serious adverse events | 0 / 224 | 0 / 192 |
Outcome results
Primary
Percent of Patients With at Least One Inquiry From a Potential Living Donor
Data collection form that captures potential recipient ID (i.e. study participant), date of living donor inquiry, and donor inquiry ID, will be securely obtained from each transplant center following a 12 month period from enrollment. Data will be collected electronically for all study participants through a secure, HIPAA-compliant data server (QualityNet). The percent of patients with at least one inquiry from a potential living donor among patients who receive Living ACTS will be compared to those who receive a control website with embedded educational video.
Time frame: Baseline, 12 months
Population: Number of participants analyzed included patients that completed the visit for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Living ACTS Website | Percent of Patients With at Least One Inquiry From a Potential Living Donor | Baseline | 15.63 percentage of participants |
| Living ACTS Website | Percent of Patients With at Least One Inquiry From a Potential Living Donor | 12 months post-intervention | 15.77 percentage of participants |
| Standard Transplant Education Procedures | Percent of Patients With at Least One Inquiry From a Potential Living Donor | Baseline | 15.63 percentage of participants |
| Standard Transplant Education Procedures | Percent of Patients With at Least One Inquiry From a Potential Living Donor | 12 months post-intervention | 15.87 percentage of participants |
Secondary
Confidence in Initiating a Conversation About LDKT
10-item behavioral skills scale measures confidence in initiating a conversation about LDKT. Potential responses range from 1 to 5, total possible score range is 10-50, with higher values indicate stronger confidence.
Time frame: Baseline, Day 1 immediately post-intervention
Population: Number of participants analyzed included patients that completed the visit for each time point for the purpose of collecting data for this study outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living ACTS Website | Confidence in Initiating a Conversation About LDKT | Behavioral skills scale score at baseline | 40.38 score on a scale | Standard Deviation 7.35 |
| Living ACTS Website | Confidence in Initiating a Conversation About LDKT | Behavioral skills scale score at average 12 months post-baseline | 41.98 score on a scale | Standard Deviation 6.88 |
| Standard Transplant Education Procedures | Confidence in Initiating a Conversation About LDKT | Behavioral skills scale score at baseline | 39.45 score on a scale | Standard Deviation 6.63 |
| Standard Transplant Education Procedures | Confidence in Initiating a Conversation About LDKT | Behavioral skills scale score at average 12 months post-baseline | 40.46 score on a scale | Standard Deviation 6.85 |
Secondary
Knowledge and Understanding of Donation/Transplantation Assessment Score
Scale includes 13 true/False questions, score ranges from 0 to 13, 0 Min-13 Maximum where higher scores indicate greater knowledge (i.e., participants receive 1 point for each correct answer).
Time frame: Baseline, Day 1 immediately post-intervention
Population: Number of participants analyzed included patients that completed the visit for each time point for the purpose of collecting data for this study outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living ACTS Website | Knowledge and Understanding of Donation/Transplantation Assessment Score | Knowledge assessment score at baseline | 10.00 score on a scale | Standard Deviation 1.49 |
| Living ACTS Website | Knowledge and Understanding of Donation/Transplantation Assessment Score | Knowledge assessment score at average 12 months post-intervention | 10.14 score on a scale | Standard Deviation 1.45 |
| Standard Transplant Education Procedures | Knowledge and Understanding of Donation/Transplantation Assessment Score | Knowledge assessment score at baseline | 10.18 score on a scale | Standard Deviation 1.6 |
| Standard Transplant Education Procedures | Knowledge and Understanding of Donation/Transplantation Assessment Score | Knowledge assessment score at average 12 months post-intervention | 10.03 score on a scale | Standard Deviation 1.72 |
Secondary
Motivation Scale Score to Ask a Family Member to be a Living Donor
9-item scale assesses motivation to ask a family member to be a living donor. Potential responses range from 1 to 5, Possible score range from 9 to 45 with higher values indicating stronger agreement with the statement.
Time frame: Baseline, Day 1 immediately post-intervention
Population: Number of participants analyzed included patients that completed the visit for each time point for the purpose of collecting data for this study outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Living ACTS Website | Motivation Scale Score to Ask a Family Member to be a Living Donor | Motivation scale score at baseline | 36.03 score on a scale | Standard Deviation 5 |
| Living ACTS Website | Motivation Scale Score to Ask a Family Member to be a Living Donor | Motivation scale score at average 12 months post-intervention | 37.00 score on a scale | Standard Deviation 4.93 |
| Standard Transplant Education Procedures | Motivation Scale Score to Ask a Family Member to be a Living Donor | Motivation scale score at baseline | 35.58 score on a scale | Standard Deviation 4.86 |
| Standard Transplant Education Procedures | Motivation Scale Score to Ask a Family Member to be a Living Donor | Motivation scale score at average 12 months post-intervention | 36.38 score on a scale | Standard Deviation 4.98 |