Lung Transplant READY CF 2: A Multi-site RCT

NCT06030206 | Active Not Recruiting DMC

• 2 other identifiers: STUDY000165851R01NR020470-01A1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 11

Brief Summary

Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. 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. Rates of death without transplant are higher for people with CF who are members of marginalized communities, including those with Black race, Hispanic ethnicity, or low socioeconomic status. 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 people with CF once their forced expiratory volume in one second (FEV1) is \<50% 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. 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. Investigators also aim to understand whether there are unique factors that affect people with CF from communities with decreased access to transplant ("communities of concern"). Study involvement will span 6 months and study activities will involve the following:

• Four Zoom research sessions (15-30 minutes each)
• Survey assessments
• Access to a research website that contains educational resources about lung transplant
• Audio recording of a routine CF clinic visit to determine if and how lung transplant is discussed between a participant and his/her/their CF doctor

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Lung Transplantation; Advanced Lung Disease; Decision Support Tool

Outcome Measures

Primary Outcomes (1)

• Preparedness for Shared Decision Making (PrepDM) Scale

  The primary endpoint is an intention-to-treat assessment of the difference in mean Preparedness for Shared Decision Making (PrepDM) Scale in the intervention versus attention-control arms of the study at the 3-month study visit using linear mixed models. Scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.

  Measured at the 3-month study visit

Secondary Outcomes (5)

• Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)

  Measured at 3-month study visit

• Decisional Conflict Scale

  Baseline to 3-month study visit

• Likert-scale rating of preparedness to discuss lung transplant (0-4)

  Measured at 3-month study visit

• Patient Health Questionnaire (PHQ-9)

  Measured at 3-month study visit

• Generalized Anxiety Disorder 7-item (GAD-7) Scale

  Measured at 3-month study visit

Other Outcomes (12)

• 6-month assessment of Preparedness for Shared Decision Making (PrepDM) Scale

  Measured at 6-month study visit

• 6-month assessment for confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)

  Measured at 6-month study visit

• 6-month assessment for Decisional Conflict Scale

  Measured at 6-months study visit

Study Arms (2)

Intervention

EXPERIMENTAL

Access to an investigator-designed web-based educational resource with information about lung transplant for three months.

Behavioral: Investigator-designed lung transplant education resource (Research Intervention)

Attention-control

ACTIVE COMPARATOR

Access to a publicly available web-based educational resource with information about transplant for three months.

Behavioral: Publicly available transplant education resource (Attention-control)

Interventions

Publicly available transplant education resource (Attention-control) BEHAVIORAL

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

Attention-control

Investigator-designed lung transplant education resource (Research Intervention) BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cystic fibrosis
• FEV1 less than 50% of predicted

You may not qualify if:

• People who are unable to provide informed consent
• People who are lung transplant recipients
• Unable to read or understand English or Spanish to complete surveys or access the website (currently only available in English and Spanish)

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (11)

University of California at Los Angeles (UCLA)

Los Angeles, California, 980095, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Maine Health

Portland, Maine, 04102, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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.

  PMID: 30926322 BACKGROUND

• Hartzler AL, Bartlett LE, Hobler MR, Reid N, Pryor JB, Kapnadak SG, Berry DL, Lober WB, Goss CH, Ramos KJ; Take on Transplant Study Group. Take on transplant: human-centered design of a patient education tool to facilitate informed discussions about lung transplant among people with cystic fibrosis. J Am Med Inform Assoc. 2022 Dec 13;30(1):26-37. doi: 10.1093/jamia/ocac176.

  PMID: 36173364 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Kathleen Ramos, MD, MSc

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School or Medicine

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 8, 2023
• Study Start: September 6, 2023
• Primary Completion: March 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the results of the primary analyses of the study. The data will be available for up to 3 years after the end of the study.
• Access Criteria: Qualified researchers with appropriate clinical research training and/or mentorship will be allowed to have access to IPD after approval is obtained from Human Subjects Division(s) and the study PI.

Locations

US (11)