Our population includes English-speaking African American patients with ESRD who are age 18 years or older and who have initiated dialysis within one year prior to study enrollment. We exclude participants if they have dementia (assessed in-person) 42 or if they have a self reported history of prior kidney transplant, cancer within 2 years prior to recruitment, stage IV congestive heart failure, end stage liver disease, pulmonary hypertension, severe peripheral vascular disease, or chronic (debilitating) infections. We assess participants’ eligibility via questions administered by a research assistant in-person in dialysis units. After potentially eligible patients agree to participate, we request a release of medical records from each participant to confirm their eligibility for the study and to ascertain whether potential donors have contacted local transplant centers to be evaluated as donors on behalf of participants.

We recruit participants from academically affiliated and community-based dialysis centers in the Baltimore, MD metropolitan region, which we have selected to provide an adequate number of African American participants with new-onset ESRD. We recruit patients on-site from different dialysis centers on different days. We systematically rotate recruitment days at sites so variations in patient scheduling at all sites can be covered to achieve the maximum number of recruitment opportunities. Upon confirmation of their eligibility to participate, we randomly assign patients into intervention groups.

Potential kidney donors only become aware of the financial assistance program through direct referral by enrolled study participants. Research study staff do not contact or attempt to contact any family, friends, or acquaintances of enrolled patient participants. Therefore, enrolled participants will be directed to contact study staff in the event they want to refer potential donors to the program. To be eligible to participate, potential donors must speak English and be 18 years or older. Once potential donors contact study staff, study staff arrange for a time to meet with the potential donor(s) in person and mail them the brochure describing the financial assistance program. At that time, study staff explain the financial assistance program to potential donors, including what they will be asked to do as part of the study. Potential donors are notified that participation in the financial assistance program offered by the study may preclude them from receiving financial assistance from any other program (e.g., National Living Donor Assistance Center). If potential donors wish to participate in the financial assistance program, we obtain consent for their participation in the study using approved consent procedures.

Using blind and secure allocation by computer, we randomly assign participants to one of three intervention arms: 1) control group (“Usual Care”, N=70); 2) the informational intervention (“PREPARED”, N=70); and 3) the informational plus the financial assistance interventions (“PREPARED plus Financial Assistance”, N=70). Randomization is blocked by recruitment site to ensure equal allocation within each dialysis facility.

Participants randomly assigned to receive Usual Care proceed with their clinical care in dialysis centers as already routinely implemented by their physicians. At study conclusion, participants will receive informational materials provided in PREPARED (educational video and written handbook) after follow up assessments have been completed.

Participants randomly assigned to the PREPARED program receive the informational intervention, which consists of an educational video and written handbook intended to be used together to inform patients’ decisions about their kidney disease treatment choices. These materials are provided to participants on a day when they do not receive dialysis in the dialysis center. Participants meet with trained research study staff during which time they are oriented to the book and watch the video. Study staff members also encourage participants to share the materials with their families and health care providers. Participants randomly assigned to the PREPARED plus Financial Assistance program receive the informational intervention at the time of enrollment in a similar fashion with a similar approach to the PREPARED assignment. In addition, participants in this group are invited to participate in the live kidney donor financial assistance program as described above.

All patient participants enrolled in the study are assessed using an in-person questionnaire at the time of recruitment and a structured telephone interview at baseline, 1 month, 3 months, and 6 months. Trained study staff administer all telephone interviews. For the informational and financial intervention arms, participants are contacted via telephone to determine whether they have viewed the materials provided to them (an educational video and written handbook for the informational intervention and the brochure for the financial intervention arm) again at home. Participants are also asked if they have shared or discussed the content of intervention materials with family members.

The primary outcome of interest is patients’ pursuit of LRT over six months of follow up. This outcome is measured as participants’ achievement of at least one of six key steps toward pursuing LRT, including: 1) execution of patient-family discussions about LRT; 2) execution of patient-physician discussions about LRT; 3) initiation of the recipient evaluation for LRT; 4) completion of the recipient evaluation for LRT, 5) identification of a potential live kidney donor, and 6) being listed at a transplant center. Pursuit of LRT will be assessed via questionnaires administered via telephone questionnaire at baseline, 1 month, 3 months and 6 months follow-up time periods. For participants reporting being registered on a transplant waiting list, we will contact transplant centers to determine whether there have been any live donor inquiries on behalf of the participant. We will also assess whether patient participants receive LRT and whether patient participants’ family members inquire about or use the financial assistance program (for those randomized to the PREPARED plus Financial Assistance arm).

Other measures include assessment of participants’ (1) knowledge of LRT; (2) interest in LRT; (3) perceived barriers to LRT; (4) preferred role in decision-making about LRT; (5) concerns about the risks of LRT to themselves and to donors 43 44 45 ; (6) family structure and relationships 46 ; (7) interest in other forms of renal replacement therapy (i.e., peritoneal dialysis or home-hemodialysis); (8) satisfaction with hemodialysis therapy; (9) depression and social support 47 48 ; (10) financial stress 49 ; (11) health literacy 50 and numeracy 51 52 ; (12) trust in the medical system 53 54 , (13) comorbid conditions 55 and (14) sociodemographic characteristics. For patient participants assigned to the PREPARED and PREPARED plus Financial Assistance groups, we also assess their perceptions of the helpfulness of the video and handbook. In all study groups, we also assess the number of donor inquiries on behalf of study participants at local transplant centers (Table 1).

*Abbreviations are as follows: living related kidney transplantation (LRT); arteriovenous (AV); primary care evaluation of mental disorders/patient health questionnaire (PRIME-MD/PHQ).

Randomly assigned intervention group (i.e. Usual Care, PREPARED, PREPARED plus Financial Assistance) will be the main independent variable for intent-to-treat analyses. In our primary analyses, we will assess the proportion of participants in each group achieving at least one new LRT pursuit behavior over 6 months. We will use multivariable models (e.g. logistic regression) to assess differences in the odds of achieving LRT pursuit behaviors among study groups while adjusting for study site characteristics and other baseline characteristics found not to be balanced by randomization. Secondary analyses will include exploratory analyses among persons within subgroups defined post-randomization--for example, analyses among persons with greater versus lesser knowledge of LRT at baseline. We will conduct primary analyses under the assumption that data is missing at random, however, we will also perform sensitivity analyses based on other scenarios (i.e. patterns of missing data) to evaluate the robustness of our assumptions.

We are aware of no other randomized controlled trials evaluating the effectiveness of informational (focused on shared decision-making) or financial interventions on commitment to LRT in incident dialysis patients. In our own work, an educational intervention resulted in patients’ greater pursuit of LRT (30% achieving new LRT behavior in Usual Care arm compared to 50% in education arm over 6 months) 19 . Our own previous work also demonstrated African Americans in the US general public were supportive of live kidney donors receiving reimbursement for expenses related to donation 24 . We anticipate the financial intervention, which addresses a common and tangible barrier to live kidney donation, may improve pursuit of LRT by an additional 10%. Based on these assumptions, we will have over 80% power to detect a trend of increasing pursuit of LRT across groups (e.g., 30% in Usual Care, 50% in PREPARED group, 60% in PREPARED plus Financial Assistance group) at 6 months. We will also have over 80% power to detect a 30% difference between the PREPARED group and the Usual Care group or the PREPARED plus Financial Assistance group and the Usual Care group individually with correction for multiple comparisons.