A randomized controlled trial of Explore Transplant at Home to improve transplant knowledge and decision-making for CKD 3-5 patients at Kaiser Permanente Southern California.Waterman, A. D., Anderson, C. et al. (2019).
BMC Nephrology; 20(1): 78.
This study aims to assess effectiveness of Explore transplant at home ([email protected]) in English and Spanish for CKD stage 3-5 patients in increasing LDKT knowledge and decision-making by race/ethnicity and primary language spoken as compared to the standard Kaiser Permanente Southern California (KPSC) education.
Patients will be randomly assigned to one of two education conditions: [email protected] or KPSC standard of care education.
1200 English and Spanish-speaking CKD Stage 3-5 patients (n=600 [email protected] intervention; n=600 KPSC education intervention).
The primary outcome measures include patients’ knowledge of CKD and the risks and benefits of transplant and the capacity to make an informed decision about transplant. Secondary outcomes will include self-efficacy to pursue deceased donor kidney transplant (DDKT), living donor kidney transplant (LDKT) and steps taken towards transplant.
This is the published protocol of an interesting RCT reviewing the effectiveness of the existing Explore [email protected] programme in CKD 3-5 patients to increase knowledge about the risks and benefits of living donor kidney transplantation in a racially, ethnically and geographically diverse population. The study also aimed to assess existing knowledge and decision-making regarding the risks and benefits of living donor kidney transplantation (before the intervention). The Explore [email protected] is focused on teaching patients about their treatment options and supporting their decision-making. With an expected response rate of 20%, 6000 patients will be invited by email and recruitment will be stratified by race/ethnicity, language spoken, and CKD stage. After completion of a first survey, patients will be randomised according to a sequence generated by the data capture system. Black, Hispanic, Asian and White patients will be randomised to a video-guided Explore [email protected] programme delivered by mail including bimonthly postcards and texting over six months or to standard education (1-2 hour course). The primary outcome will be knowledge at 6 months and the sample calculation showed that 1200 patients would provide a power of 90% to detect 0.25 effect size with an expected retention rate of 50% at 6 months. The investigators aim to understand key knowledge gaps in this patient population and between patients speaking different languages. Additionally, the investigators hope that the programme will help to reduce disparities in access to transplant and serve as a model for other healthcare systems.
Protocol - QA not necessary.
ClinicalTrials.gov - NCT02058590