Lung Transplant READY Pilot Study

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)

Conditions

• Cystic Fibrosis

Interventions

BEHAVIORAL

Investigator-designed lung transplant education resource (Research Intervention)

Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.

BEHAVIORAL

Publicly available transplant education resource (Attention Control)

Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Cystic Fibrosis Foundation

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Kathleen Ramos, MD, MS · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-06

Primary Completion

2022-11-01

Completion

2022-11-01

Countries

• United States

Study Locations