Clinical trial NCT05135156: Lung Transplant READY Pilot Study
Official title: Lung Transplant Resources for Education and Decision-making for Your Cystic Fibrosis (READY): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Lung Transplantation
Lung Disease
Decision Support Tool
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Cystic Fibrosis Foundation
First posted: 2021-11-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant.

The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with CF patients once their forced expiratory volume in one second (FEV1) is \<50% predicted. Considering lung transplant as a treatment option ahead of when it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist.

Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant.

Study involvement will span 4 weeks and study procedures will involve the following:

* Three Zoom interview sessions (30-60 minutes each)
* Survey assessments
* Access to a research website that contains educational resources about lung transplant (goal of 4 hours of use over the 4 week study period)

Detailed description: Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, 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 people with CF who die without lung transplant were never referred for consideration, with patients of lower socioeconomic status 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 individuals 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 ahead of when 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 have developed a novel lung transplant decision support tool that addresses patient-identified knowledge gaps and provides personalized educational content to help people with CF prepare for lung transplant discussions and decisions. The decision support tool 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 pilot study are to test the efficacy of the decision support tool 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 new website will be compared against an attention control website (UNOS.org) to better understand how people with CF use and rank different educational resources' utility. The central hypothesis is that use of the new decision support tool 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 UNOS.org.

The pilot study will be a randomized controlled trial. Participants will be randomized 1:1 to one of two educational resources, described above, stratified by FEV1 category (FEV1 30-50% or FEV1 \<30% of predicted). 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. Baseline interviews will address perspectives on lung transplant as a treatment option for CF and the role of newer CF therapies in the decision making process about lung transplant. For two weeks, 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, along with a second brief interview. After the 2-week study visit, participants will have access to both educational resources via individual login to the secure research website. At 4 weeks, there will be a study visit to repeat the surveys and interview. Throughout the 4 weeks, web analytics will be captured at the individual level to determine usage patterns for both educational resources.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis
* FEV1 less than or equal to 50% predicted (unless referred per MD recommendation)

Exclusion Criteria:

* Patients unable to provide informed consent
* Patients who are lung transplant recipients
* Unable to read or understand English to complete surveys or access the websites (currently only available in English)

Primary outcomes:
measure: Feasibility of Participants Completing 2-week Study Visit
timeFrame: Measured at 2-week study visit
measure: Preparedness for Shared Decision Making (PrepDM) Scale
timeFrame: Measured at 2-week study visit
Secondary outcomes:
measure: Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey)
timeFrame: Measured at 2-week study visit
measure: Decisional Conflict Scale
timeFrame: Baseline to 2-week study visit
measure: Likert-scale Rating of Preparedness to Discuss Lung Transplant (0-4)
timeFrame: Measured at 2-week study visit
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Measured at 2-week study visit
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Measured at 2-week study visit
measure: Generalized Anxiety Disorder 7-item (GAD-7) Scale
timeFrame: Measured at 2-week study visit
measure: Generalized Anxiety Disorder 7-item (GAD-7) Scale
timeFrame: Measured at 2-week study visit
Other outcomes:
measure: 4-week Assessment of Preparedness for Shared Decision Making (PrepDM) Scale
timeFrame: Measured at 4-week study visit
measure: 4-week Assessment for Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey)
timeFrame: Measured at Baseline, 2-week study visit, 4-week study visit
measure: 4-week Assessment for Decisional Conflict Scale
timeFrame: Measured at Baseline, 2-week study visit, 4-week study visit
measure: 4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant
timeFrame: Measured at baseline, 2-week and 4-week study visits
measure: Time Spent Using the Research Website
timeFrame: Baseline to 2-week study visit
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kathleen Ramos, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramos KJ, Smith PJ, McKone EF, Pilewski JM, Lucy A, Hempstead SE, Tallarico E, Faro A, Rosenbluth DB, Gray AL, Dunitz JM; CF Lung Transplant Referral Guidelines Committee. Lung transplant referral for individuals with cystic fibrosis: Cystic Fibrosis Foundation consensus guidelines. J Cyst Fibros. 2019 May;18(3):321-333. doi: 10.1016/j.jcf.2019.03.002. Epub 2019 Mar 27.
citation: Leard LE, Holm AM, Valapour M, Glanville AR, Attawar S, Aversa M, Campos SV, Christon LM, Cypel M, Dellgren G, Hartwig MG, Kapnadak SG, Kolaitis NA, Kotloff RM, Patterson CM, Shlobin OA, Smith PJ, Sole A, Solomon M, Weill D, Wijsenbeek MS, Willemse BWM, Arcasoy SM, Ramos KJ. Consensus document for the selection of lung transplant candidates: An update from the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2021 Nov;40(11):1349-1379. doi: 10.1016/j.healun.2021.07.005. Epub 2021 Jul 24.
citation: Ramos KJ, Hobler MR, Engelberg RA, Curtis JR, Zander MI, Howard SS, Goss CH, Aitken ML. Addressing lung transplant with adults with cystic fibrosis: A qualitative analysis of patients' perspectives and experiences. J Cyst Fibros. 2019 May;18(3):416-419. doi: 10.1016/j.jcf.2019.04.007. Epub 2019 Apr 17.