The “House Calls” Trial: A Randomized Controlled Trial to Reduce Racial Disparities in Live Donor Kidney Transplantation: Rationale and Design

• Published in: Contemporary clinical trials Vol. 33; no. 4; pp. 811 - 818
• Main Authors: Rodrigue, James R, Pavlakis, Martha, Egbuna, Ogo, Paek, Matthew, Waterman, Amy D, Mandelbrot, Didier A
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-07-2012
• Subjects: Adult; African Americans; Aged; Aged, 80 and over; Cardiovascular; Clinical Protocols; Cultural Competency; Disparities; Health Knowledge, Attitudes, Practice - ethnology; Healthcare Disparities - ethnology; Hematology, Oncology and Palliative Medicine; House Calls; Humans; Intention to Treat Analysis; Kidney transplantation; Kidney Transplantation - education; Kidney Transplantation - ethnology; Kidney Transplantation - methods; Kidney Transplantation - statistics & numerical data; Living donation; Living Donors - statistics & numerical data; Middle Aged; Multivariate Analysis; Patient Acceptance of Health Care - ethnology; Patient Acceptance of Health Care - statistics & numerical data; Patient Education as Topic - methods; Randomized trial; Research Design; Transplant education; Transplant education; Randomized trial; Disparities; Living donation; Kidney transplantation
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2012.03.015

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.