(148) Lung Transplant READY: Pilot randomized clinical trial of a self-directed patient-facing lung transplant education website

Background: People with cystic fibrosis (CF) face uncertainty when considering lung transplant (LTx) in the era of highly effective CF therapeutics. Our team created Take on Transplant (ToT), a web-based educational resource that provides personalized, up-to-date, guideline-based LTx content alongside personal narratives from individuals with CF and caregivers. We compare ToT with more general transplant education resources from the United Network for Organ Sharing (UNOS) website (unos.org) on preparedness for LTx discussions in a pilot randomized clinical trial (RCT). Recruitment of participants is focused on those with disadvantaged access to LTx.

Methods: Study design: A pilot randomized, single-blind, roll over study to assess feasibility and evaluate the effect of ToT on preparedness for LTx discussions, measured by the Preparation for Decision Making Scale (PrepDM) [Bennet C, et al. 2010]. Demographics and health literacy are obtained at baseline. Participants are randomized to access one of two websites (ToT or UNOS) for 2 weeks. Serial surveys performed during study visits via Zoom at baseline, 2-weeks, and 4-weeks assess ToT efficacy for preparedness and impact on psychological endpoints compared to an attention control website (UNOS). After the 2-week visit, all study participants gain access to both websites for an additional 2 weeks. We continuously capture individual-level website usage data for all participants throughout the RCT.

Participants: Adults with CF (n=50) and an FEV1 less than 50% of predicted and no prior LTx are included, with attention to enrollment of participants from communities of concern, defined as Medicaid insurance, non-White race, Hispanic ethnicity, or high school education or less. Participants are recruited from CF Centers in the United States and randomized to ToT or UNOS within FEV1 strata (30-50% or < 30% predicted).

Primary and secondary endpoints: The co-primary outcomes are feasibility of completion of the 2-week study visit and participant rating of preparedness for LTx discussion via the PrepDM at 2 weeks. The primary analysis compares mean PrepDM score between the ToT and UNOS arms using linear mixed models. Secondary outcomes include change in Decisional Conflict Scale [O’Conor AM, 1995], Likert rating of preparedness for LTx discussions, and LTx knowledge assessment (14 questions, investigator-designed), along with mental health (PHQ-9, GAD-7) and quality of life endpoints (CFQ-R) [Quittner AL, 2005]. We will also explore dose-response relationships by estimating the association between change in outcomes from baseline to 2 weeks and 2 weeks to 4 weeks, with time spent using ToT.

Results: To date, 23 participants are enrolled in the pilot RCT, 78% from communities of concern, and 100% completed 2-week study visits. We expect the last participant to finish the study protocol in July 2022. There are no interim efficacy results available.

Conclusions: Final data will be available for presentation at the 2022 North American CF Conference.

Acknowledgements: This work was supported by the National Institutes of Health [R03HL158728, K23HL138154] and the Cystic Fibrosis Foundation [RAMOS20A0-KB, RAMOS17A0]. We acknowledge the life and contributions of Dr. Mara Hobler. We also thank the following groups for their contributions to this work: people with CF across the United States, the Take on Transplant Study Group, UW Clinical Informatics Research Group (CIRG), and the Cystic Fibrosis Foundation Community Voice (Bethesda, MD).

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