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Lung Transplant READY Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05135156
Recruitment Status : Recruiting
First Posted : November 26, 2021
Last Update Posted : June 3, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Kathleen Ramos, University of Washington

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)

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Behavioral: Investigator-designed lung transplant education resource (Research Intervention) Behavioral: Publicly available transplant education resource (Attention Control) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Lung Transplant Resources for Education and Decision-making for Your Cystic Fibrosis (READY): A Pilot Randomized Controlled Trial
Actual Study Start Date : December 6, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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)
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.

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




Primary Outcome Measures :
  1. Feasibility of participants completing 2-week study visit [ Time Frame: Measured at 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).

  2. Preparedness for Shared Decision Making (PrepDM) Scale [ Time Frame: Measured at 2-week study visit ]
    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.


Secondary Outcome Measures :
  1. Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) [ Time Frame: Measured at 2-week study visit ]
    Difference in mean confidence-weighted true false (CTF) knowledge score will be measured in the intervention versus control arms of the study. CTF scoring adds points for certainty in correct responses and deducts points for certainty in incorrect responses. Participants receive +2 points when "sure" about a correct response, +1 if unsure about a correct response, -1 if unsure about an incorrect response and -2 if sure about an incorrect response. For a 14-item knowledge test, the maximum score is +28 and the minimum score is -28, with higher scores indicating more knowledge about lung transplant.

  2. Decisional Conflict Scale [ Time Frame: Baseline to 2-week study visit ]
    Decisional Conflict Scale change will be measured from the baseline study visit to the 2-week study visit. The intention-to-treat analysis will compare mean change in the Decisional Conflict Scale between the intervention and control arms of the study. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].

  3. Likert-scale rating of preparedness to discuss lung transplant (0-4) [ Time Frame: Measured at 2-week study visit ]
    Likert rating of preparedness will be measured at the 2-week study visit (0=Don't know, 1= Not at all prepared, 2 = A little prepared, 3 = Moderately prepared, 4 = Very prepared). The intention-to-treat analysis will compare mean Likert-scale rating between the intervention and control arms of the study.

  4. Patient Health Questionnaire (PHQ-9) [ Time Frame: Measured at 2-week study visit ]
    PHQ-9 is a scale that measures symptoms of depression in the prior 2 weeks on a 0-27 scale, with higher scores indicating worsening depression and a score of 10 or higher consistent with a diagnosis of depression. Investigators will assess the difference in mean PHQ-9 score in the intervention versus control arms of the study at the 2-week study visit. Investigators will also determine the proportion with new PHQ-9 score greater than or equal to 10 in each arm.

  5. Generalized Anxiety Disorder 7-item (GAD-7) Scale [ Time Frame: Measured at 2-week study visit ]
    GAD-7 is a scale that measures symptoms of anxiety in the prior 2 weeks on a 0-21 scale, with higher scores indicating worsening anxiety and a score of 10 or higher consistent with a diagnosis of generalized anxiety disorder. Investigators will assess the difference in mean GAD-7 score in the intervention versus control arms of the study at the 2-week study visit. Investigators will also determine the proportion with new GAD-7 score greater than or equal to 10 in each arm.


Other Outcome Measures:
  1. 4-week assessment of Preparedness for Shared Decision Making (PrepDM) Scale [ Time Frame: Measured at 4-week study visit ]
    The PrepDM Scale will be measured for all participants with respect to the investigator-designed educational resource (research intervention) and mean score will be compared for participants in the intervention (4 weeks of exposure) versus control arms (2 weeks of exposure). PrepDM scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.

  2. 4-week assessment for confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) [ Time Frame: Measured at 4-week study visit ]
    Change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) will be assessed from baseline to 4-weeks for participants in the intervention arm and from 2-week to 4-week study visits for participants in the Attention Control arm. Mean difference in the knowledge score (range -28 to +28) will be compared between study arms. Higher scores indicate more knowledge about lung transplant.

  3. 4-week assessment for Decisional Conflict Scale [ Time Frame: Measured at 4-week study visit ]
    Change in Decisional Conflict Scale will be assessed from baseline to 4-weeks for participants in the intervention arm and from 2-week to 4-week study visits for participants in the Attention Control arm. Difference in the mean change in Decisional Conflict Scale will be compared between study arms. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].

  4. 4-week assessment for Likert-scale rating of preparedness to discuss lung transplant [ Time Frame: Measured at baseline, 2-week and 4-week study visits ]
    Evaluate the proportion "Very prepared" at baseline, 2 weeks and 4 weeks in the intervention and control arms. Compare proportions across study arms at each time point.

  5. Time spent using the research website [ Time Frame: Baseline to 2-week study visit ]
    Average time spent using the research website from baseline to 2 weeks will be compared across study arms. Further, time spent using the investigator-designed website will be assessed as a predictor of: 1. change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visit, 2. change in Likert preparedness from baseline to 2-week study visit, 3. change in Decisional Conflict Scale from baseline to 2-week study visit, and 4. mean PrepDM Scale at 2-weeks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135156


Contacts
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Contact: Lauren Bartlett, BS, CCRC 503-583-2869 lrejman@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Lauren Bartlett, BS, CCRC    503-583-2869    lrejman@uw.edu   
Principal Investigator: Kathleen Ramos, MD, MS         
Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Kathleen Ramos, MD, MS University of Washington
Publications:
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Responsible Party: Kathleen Ramos, Assistant Professor, School of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT05135156    
Other Study ID Numbers: STUDY00011578
1R03HL158728-01 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) may be shared with other researchers for secondary analyses with the approval of the appropriate Human Subjects Division(s) and the study's principal investigator (PI).
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathleen Ramos, University of Washington:
Cystic Fibrosis
Lung Transplantation
Lung Disease
Decision Support Tool
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases