Title:  Kidney paired donation: A randomized trial to increase knowledge and reduce perceived barriers

Funding:  NIH- NIDDK (R01DK114877)

ClinicalTrials.gov:  NCT03268850

Summary

This is a single-center study using a blended randomized trial and historically controlled design in which 350 KT candidates will be randomly assigned 1:1 to one of two parallel arms: (1) possible reimbursement of LD lost wages up to a maximum amount (LW-A) or (2) possible reimbursement of LD lost wages up to a different maximum amount (LW-B) and compared to 350 historical controls matched for age (+/- 5 yrs.), sex, and race/ethnicity. Also, we will examine whether the intervention reduces or eliminates the difference in LDKT rate between white and minority study patients, compared to the historical difference in LDKT rate by race at BIDMC over the last 5 yrs. In addition to the primary outcome of LDKT occurrence at 12 months, we will assess intervention effects on LD inquiries and evaluations and on patient and potential LD decision-making.

A secondary sample of potential LDs (for KT candidates enrolled in the trial) will be recruited to assess concern about lost wages and the importance of possible wage reimbursement on decision-making about donation. Those who undergo donor surgery (i.e., “actual LDs”) will participate in additional assessments as described below. Our own data show an average of 1.1 potential LD evaluations per KT candidate; thus, we anticipate recruiting 385 potential LDs, of which we estimate ~90 will become actual LDs.

To evaluate our central hypotheses and meet the study objective, we will pursue three specific aims:

Aim 1: Evaluate the effectiveness of offering reimbursement for LD lost wages on the LDKT rate in KT candidates. Hypothesis 1a: KT candidates who are offered reimbursement for LD lost wages will have a higher likelihood of LDKT (primary outcome) by the 1-yr study endpoint, compared to historical controls matched for age group, sex, and race/ethnicity. Hypothesis 1b: KT candidates who are offered reimbursement for LD lost wages will have a higher likelihood of ≥1 LD inquiry and ≥1 LD evaluation (secondary outcomes) by the 1-yr study endpoint, compared to historical controls matched for age group, sex, and race/ethnicity. Hypothesis 1c: KT candidates who are offered reimbursement for LD lost wages will show increases in LDKT willingness and fewer LDKT concerns over time.

Aim 2: Examine whether offering reimbursement for LD lost wages reduces known racial disparity in LDKT. Hypothesis 2a: The difference in LDKT rate between white and minority patients will be significantly smaller for KT candidates who are offered reimbursement for LD lost wages, compared to the historical difference in LDKT rate by race at BIDMC. Hypothesis 2b: Primary and secondary outcomes will be moderated by race and income status of the KT candidate, such that outcomes will be more favorable for minority and low-income KT patients.

Aim 3: Determine whether study outcomes differ significantly by maximum reimbursement amount for LD lost wages. Hypothesis 3: KT candidates who are offered a higher reimbursement for LD lost wages will have a higher likelihood of LDKT (primary outcome) and higher likelihood of ≥1 LD inquiry and ≥1 LD evaluation (secondary outcomes) by the 1-yr study endpoint, compared to those offered up to a lower maximum amount of reimbursement for LD lost wages.

Related Publications:

Hays R, Rodrigue JR, Cohen D, Danovitch G, Matas A, Schold J, LaPointe Rudow D. Financial neutrality for living organ donors: Reasoning, rationale, definitions and implementation strategies. Am J Transplant. 2016; 16:1973-81.

Rodrigue JR, Schold JD, Mandelbrot DA, Taber DJ, Phan V, Baliga P. Concern for lost income following donation deters some patients from talking to potential living donors. Prog Transplant. 2016.

Rodrigue JR, Schold JD, Morrissey J, Whiting J, Vella J, Kayler L, Katz D, Jones J, Kaplan B, Fleishman A, Pavlakis M, Mandelbrot DA. Direct and indirect costs following living kidney donation: Findings from the KDOC study. Am J Transplant. 2016; 16:869-76.

Rodrigue JR, LaPointe Rudow D, Hays R; American Society of Transplantation.Living Donor Kidney Transplantation: Best Practices in Live Kidney Donation–Recommendations from a Consensus Conference.Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1656-7. doi: 10.2215/CJN.00800115. Epub 2015 Aug 14.

Tushla L, LaPointe Rudow D, Milton J, Rodrigue JR, Schold JD, Hays R. Reducing financial barriers to live kidney donation: Recommendations from a consensus conference. Clin J Am Soc Nephrol. 2015; 10:1696-702.

Rodrigue JR, Schold JD, Mandelbrot DA. The decline in living kidney donation in the United States: Random variation or cause for concern? Transplantation. 2013; 96:767-73.