Lung Transplant READY Pilot Study

NCT05135156 | Completed Results DMC

• 2 other identifiers: STUDY000115781R03HL158728-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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)

Conditions

Cystic Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Feasibility of Participants Completing 2-week Study Visit

  The co-primary endpoint is feasibility, which will be defined as successful if 90% of enrolled participants complete the 2-week study visit (regardless of study arm).

  Measured at 2-week study visit

• Preparedness for Shared Decision Making (PrepDM) Scale

  The co-primary endpoint is an intention-to-treat assessment of the difference in mean Preparedness for Shared Decision Making (PrepDM) Scale in the intervention versus control arms of the study at the 2-week study visit. Scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.

  Measured at 2-week study visit

Secondary Outcomes (7)

• Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey)

  Measured at 2-week study visit

• Decisional Conflict Scale

  Baseline to 2-week study visit

• Likert-scale Rating of Preparedness to Discuss Lung Transplant (0-4)

  Measured at 2-week study visit

• Patient Health Questionnaire (PHQ-9)

  Measured at 2-week study visit

• Patient Health Questionnaire (PHQ-9)

  Measured at 2-week study visit

Other Outcomes (5)

• 4-week Assessment of Preparedness for Shared Decision Making (PrepDM) Scale

  Measured at 4-week study visit

• 4-week Assessment for Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey)

  Measured at Baseline, 2-week study visit, 4-week study visit

• 4-week Assessment for Decisional Conflict Scale

  Measured at Baseline, 2-week study visit, 4-week study visit

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Control

ACTIVE COMPARATOR

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

Behavioral: Publicly available transplant education resource (Attention Control)

Interventions

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 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.

Intervention

Publicly available transplant education resource (Attention Control) BEHAVIORAL

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.

Control

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 or equal to 50% predicted (unless referred per MD recommendation)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• 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

• 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.

  PMID: 34419372 BACKGROUND

• 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.

  PMID: 31003953 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Lung Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Kathleen J. Ramos
• Organization: University of Washington

ramoskj@uw.edu

2065430393

Study Officials

• Kathleen Ramos, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Assistant Professor, School of Medicine

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: November 26, 2021
• Study Start: December 6, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 29, 2023
• Results First Posted: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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 (1)