title: Protocol of a randomized controlled trial of culturally sensitive interventions to improve African Americans' and non-African Americans' early, shared, and informed consideration of live kidney transplantation: the Talking About Live Kidney Donation (TALK) Study.
abstract: BACKGROUND
  Live kidney transplantation (LKT) is underutilized, particularly among ethnic/racial minorities. The effectiveness of culturally sensitive educational and behavioral interventions to encourage patients' early, shared (with family and health care providers) and informed consideration of LKT and ameliorate disparities in consideration of LKT is unknown.
  
  
  METHODS
  We report the protocol of the Talking About Live Kidney Donation (TALK) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test culturally sensitive interventions to improve patients' shared and informed consideration of LKT. Study Phase 1 involved the evidence-based development of culturally sensitive written and audiovisual educational materials as well as a social worker intervention to encourage patients' engagement in shared and informed consideration of LKT. In Study Phase 2, we are currently conducting a randomized controlled trial in which participants with progressing chronic kidney disease receive: 1) usual care by their nephrologists, 2) usual care plus the educational materials, or 3) usual care plus the educational materials and the social worker intervention. The primary outcome of the randomized controlled trial will include patients' self-reported rates of consideration of LKT (including family discussions of LKT, patient-physician discussions of LKT, and identification of an LKT donor). We will also assess differences in rates of consideration of LKT among African Americans and non-African Americans.
  
  
  CONCLUSIONS
  The TALK Study rigorously developed and is currently testing the effectiveness of culturally sensitive interventions to improve patients' and families' consideration of LKT. Results from TALK will provide needed evidence on ways to enhance consideration of this optimal treatment for patients with end stage renal disease.
  
  
  BACKGROUND
  ClinicalTrials.gov number, NCT00932334.
authors: Division of General Internal Medicine, Department of Medicine, Johns Hopkins School of Medicine, 2024 E, Monument Street, Baltimore, MD 21205, USA. lboulwa@jhmi.edu
authors: L Ebony
authors: LE
authors: Boulware
authors: Felicia
authors: F
authors: Hill-Briggs
authors: Edward S
authors: ES
authors: Kraus
authors: J Keith
authors: JK
authors: Melancon
authors: Raquel
authors: R
authors: McGuire
authors: Bobbie
authors: B
authors: Bonhage
authors: Mikiko
authors: M
authors: Senga
authors: Patti
authors: P
authors: Ephraim
authors: Kira E
authors: KE
authors: Evans
authors: Brenda
authors: B
authors: Falcone
authors: Misty U
authors: MU
authors: Troll
authors: Nicole
authors: N
authors: Depasquale
authors: Neil R
authors: NR
authors: Powe
mesh_terms: D001741:Black or African American / Q000208:ethnology*; D002985:Clinical Protocols; D003431:Cross-Cultural Comparison; D005260:Female; D005500:Follow-Up Studies; D007722:Health Knowledge, Attitudes, Practice / Q000208:ethnology*; D006801:Humans; D007258:Informed Consent / Q000523:psychology; D016030:Kidney Transplantation / Q000208:ethnology* / Q000523:psychology; D019520:Living Donors / Q000523:psychology; D008297:Male; D010353:Patient Education as Topic / Q000379:methods