title: The "House Calls" trial: a randomized controlled trial to reduce racial disparities in live donor kidney transplantation: rationale and design.
abstract: Despite a substantially lower rate of live donor kidney transplantation among Black Americans compared to White Americans, there are few systematic efforts to reduce this racial disparity. This paper describes the rationale and design of a randomized controlled trial evaluating the comparative effectiveness of three different educational interventions for increasing live donor kidney transplantation in Black Americans. This trial is a single-site, urn-randomized controlled trial with a planned enrollment of 180 Black Americans awaiting kidney transplantation. Patients are randomized to receive transplant education in one of three education conditions: through group education at their homes (e.g., House Calls), or through group (Group-Based) or individual education (Individual Counseling) in the transplant center. The primary outcome of the trial is the occurrence of a live donor kidney transplant, with secondary outcomes including living donor inquiries and evaluations as well as changes in patient live donor kidney transplantation readiness, willingness, knowledge, and concerns. Sex, age, dialysis status, and quality of life are evaluated as moderating factors. Findings from this clinical trial have the potential to inform strategies for reducing racial disparities in live donor kidney transplantation. Similar trials have been developed recently to broaden the evaluation of House Calls as an innovative disparity-reducing intervention in kidney transplantation.
authors.affiliation: The Transplant Institute and the Center for Transplant Outcomes and Quality Improvement, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. jrrodrig@bidmc.harvard.edu
authors.forename: James R
authors.initials: JR
authors.lastname: Rodrigue
authors.forename: Martha
authors.initials: M
authors.lastname: Pavlakis
authors.forename: Ogo
authors.initials: O
authors.lastname: Egbuna
authors.forename: Matthew
authors.initials: M
authors.lastname: Paek
authors.forename: Amy D
authors.initials: AD
authors.lastname: Waterman
authors.forename: Didier A
authors.initials: DA
authors.lastname: Mandelbrot
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D054521:Cultural Competency; D007722:Health Knowledge, Attitudes, Practice / Q000208:ethnology; D054625:Healthcare Disparities / Q000208:ethnology*; D006792:House Calls; D006801:Humans; D057194:Intention to Treat Analysis; D016030:Kidney Transplantation / Q000193:education / Q000208:ethnology* / Q000379:methods / Q000706:statistics & numerical data; D019520:Living Donors / Q000706:statistics & numerical data*; D008875:Middle Aged; D015999:Multivariate Analysis; D010342:Patient Acceptance of Health Care / Q000208:ethnology* / Q000706:statistics & numerical data; D010353:Patient Education as Topic / Q000379:methods*; D012107:Research Design