Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the US, more CF patients with forced expiratory volume in 1 second (FEV1) less than 30% of predicted die each year than undergo lung transplant. More than half of patients who die without lung transplant were never referred for consideration. This is especially relevant for disproportionately impacted communities with limited access to lung transplant ("communities of concern"), including patients of lower socioeconomic status, minoritized race (e.g. Black, Asian), or Hispanic ethnicity. Patient preference may account for 25-40% of decisions to defer referral, but may at times be informed by inaccurate assumptions. Patients' health discussion networks function to support individuals in health related matters and may provide critical support during the lung transplant journey. Increasing awareness of lung transplant, and promoting the process of deliberation and utilization of social support, could reduce the number of people with CF who die without lung transplant. The CF Foundation (CFF) lung transplant referral guidelines recommend annual discussions with patients once their FEV1 is \<50% predicted to allow patients time to become informed about lung transplant. How to integrate caregivers into this discussion is unclear.
Rather than occurring once at the point of care, deliberation is an iterative process in which patients explore what matters most to them when considering medical treatments, often requiring patient collaboration over time with health professionals and their wider social networks. Individuals with CF with all levels of FEV1 report an interest in understanding lung transplant as a potential treatment option. In addition to knowledge gaps about lung transplant identified in a survey of people with CF, investigators found a preparedness gap between how prepared patients feel for the lung transplant decision and how prepared they want to feel. Additionally, the most common patient-endorsed barrier to lung transplant discussions was a worry about being a burden on family and friends after lung transplant. For lung transplant recipients with complex post-operative courses, low social support is associated with increased mortality. Adequate social support is a requirement at all lung transplant programs in the US. Providing support for chronically ill individuals can lead to caregiver burden and burnout. Understanding how to support caregivers of individuals on the lung transplant journey is an important aspect of providing holistic care to people with CF. The CFF recommends routinely measuring caregiver burden using the Brief Assessment Scale for Caregivers (BASC).
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 and caregiver 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 parent Lung Transplant READY CF 2 study will test the efficacy of the investigator-designed website in a randomized controlled trial (RCT) incorporating mixed methods to assess preparedness for lung transplant discussions among people with CF with FEV1 \<50% of predicted, and will explore patient and physician perspectives on the use of the new website for lung transplant education in the era of highly effective CF therapeutics. The overall research objectives for the CARING CF Ancillary RCT will focus on addressing caregivers' education needs, caregiver burden, and understanding the patient-caregiver relationship in decision-making. The central hypothesis is that the investigator-designed website will increase caregivers' preparedness to engage in lung transplant discussions, will lead to greater understanding of the role of caregivers during the transplant journey, and will reduce caregiver burden.
The CARING CF study will be an ancillary RCT. Caregiver participants will take baseline surveys within 3 months of their loved one's enrollment in the parent Lung Transplant READY CF 2 RCT. When the patient participant completes the 3-month study visit in the parent RCT, caregiver participants will repeat surveys and then be randomly assigned 1:1 (stratified by patient's original study arm assignment in parent RCT and patient's baseline report of low social support) to access the investigator-designed website or have no website access for the next three months. Surveys will evaluate knowledge about lung transplant, a Likert scale rating of preparedness for lung transplant discussions, mental health, and caregiver burden (using the BASC). At 3 months after being randomly assigned, there will be a study visit that includes repeated surveys. After completion of the final surveys, all caregiver participants will gain access to the investigator-designed website via individual login to the secure research website. Throughout the 3 months of the randomized portion of the study and for a long-term follow up period of up to 4 years, web analytics will be captured at the individual level to determine caregivers' usage patterns for the research website. Caregivers may be invited to participate in an interview after completion of their final surveys. As part of this ancillary RCT, patient participants who choose to enroll will complete surveys related to their perceived social support at baseline, 3 months and 6 months after their enrollment in the parent RCT and may be invited to participate in an interview with their caregiver.
