Preparation for Lung Transplant Discussions and Decisions Among People With Cystic Fibrosis

Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF with forced expiratory volume in 1 second (FEV1) less than 30% of predicted die each year than undergo lung transplant. More than half of people with CF who die without lung transplant were never referred for consideration, with patients of lower socioeconomic status, Black race, or Hispanic ethnicity disproportionately impacted by limited access to lung transplant. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. The CF Foundation established lung transplant referral guidelines that recommend people with CF have annual conversations about lung transplant with their CF doctor once their FEV1 is less than 50% of predicted. Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. By introducing an educational resource that can increase awareness of lung transplant among patients, and promote understanding of the risks and benefits of lung transplant, investigators aim to empower people with CF to take part in shared decision-making with their CF providers, which could reduce the number of people with CF who die without lung transplant.

Based on prior research, investigators developed a novel lung transplant educational resource that addresses patient-identified knowledge gaps and provides personalized educational content to help people with CF prepare for lung transplant discussions and decisions. The web-based educational resource couples real-life CF patient experiences of lung transplant in the form of personal narratives with up-to-date, CF-specific, and guideline-based medical information about lung transplant.

The overall research objectives for this study are to test the efficacy of the investigator-designed educational resource to improve patient preparedness for shared decision making about lung transplant and knowledge about lung transplant, and to evaluate the impact on mental health outcomes (depression and anxiety). The investigator-designed website will be compared to an attention control website to better understand how people with CF use and rank different educational resources' utility. The central hypothesis is that use of the new investigator-designed website that incorporates disease severity data (FEV1 % predicted, supplemental oxygen use, exacerbations) to identify relevant personal narratives and guideline-based educational content will increase a patient's preparedness to engage in discussions about lung transplant beyond the standard information presented on the attention control website.

The study will be a randomized controlled trial. Participants will be randomly assigned 1:1 to one of two educational resources, described above, stratified by FEV1 category (FEV1 30-50% or FEV1 <30% of predicted), CF Center, and whether they are members of the "communities of concern"). The communities of concern include people with Medicaid insurance, high school education or less, Hispanic ethnicity, or Black/Asian/Other race (not White race). Baseline surveys will evaluate knowledge about lung transplant, a Likert scale rating of preparedness for lung transplant discussions, decisional conflict about lung transplant, and mental health. For three months, participants will have access to one of two educational resources via a login to a secure research website. At 2 weeks, there will be a study visit that includes repeated surveys from baseline and the Preparedness for Shared Decision Making (PrepDM) Scale. At 2 to 3 months after randomization, participants will have a routine CF clinic visit, which may be audio-recorded for evaluation of lung transplant discussion. At 3 months after randomization, there will be a study visit that includes repeated surveys from baseline and the PrepDM Scale. After the 3-month study visit, participants will have access to both educational resources via individual login to the secure research website. At 6-months, there will be a study visit to repeat the surveys. Throughout the 6-months and for a long-term follow up period of 4 years, web analytics will be captured at the individual level to determine usage patterns for both educational resources.