search
Back to results

Lung Transplant READY CF 2: A Multi-site RCT

Primary Purpose

Cystic Fibrosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigator-designed lung transplant education resource (Research Intervention)
Publicly available transplant education resource (Attention-control)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Lung Transplantation, Advanced Lung Disease, Decision Support Tool

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of cystic fibrosis FEV1 less than 50% of predicted Exclusion Criteria: 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)

Sites / Locations

  • University of California at Los Angeles (UCLA)
  • National Jewish Health
  • Yale University
  • University of Kansas
  • Maine Health
  • University of Minnesota
  • University of Cincinnati
  • University of Pittsburgh
  • University of Washington Medical Center - MontlakeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Attention-control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)
Difference in mean change in confidence-weighted true false (CTF) knowledge score will be measured in the intervention versus control arms of the study using linear mixed models. 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.
Decisional Conflict Scale
Decisional Conflict Scale change will be measured from the baseline study visit to the 3-month 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].
Likert-scale rating of preparedness to discuss lung transplant (0-4)
Likert rating of preparedness to discuss lung transplant will be measured at each 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 change in Likert-scale rating between the intervention and attention-control arms of the study using linear mixed models.
Patient Health Questionnaire (PHQ-9)
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. The intention-to-treat analysis will compare mean change in PHQ-9 between the intervention and attention-control arms of the study using linear mixed models. Investigators will also determine the proportion with new PHQ-9 score greater than or equal to 10 in each arm.
Generalized Anxiety Disorder 7-item (GAD-7) Scale
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. The intention-to-treat analysis will compare mean change in GAD-7 between the intervention and attention-control arms of the study using linear mixed models. Investigators will also determine the proportion with new GAD-7 score greater than or equal to 10 in each arm.

Full Information

First Posted
August 25, 2023
Last Updated
September 8, 2023
Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
search

1. Study Identification

Unique Protocol Identification Number
NCT06030206
Brief Title
Lung Transplant READY CF 2: A Multi-site RCT
Official Title
Preparation for Lung Transplant Discussions and Decisions Among People With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2023 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF 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, Black race, or Hispanic ethnicity 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 people 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 before 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 developed a novel lung transplant educational resource that addresses patient-identified knowledge gaps and provides personalized educational content to help people with CF prepare for lung transplant discussions and decisions. The web-based educational resource 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 study are to test the efficacy of the investigator-designed educational resource 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 investigator-designed website will be compared to an attention control website to better understand how people with CF use and rank different educational resources' utility. The central hypothesis is that use of the new investigator-designed website 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 the attention control website. The study will be a randomized controlled trial. Participants will be randomly assigned 1:1 to one of two educational resources, described above, stratified by FEV1 category (FEV1 30-50% or FEV1 <30% of predicted), CF Center, and whether they are members of the "communities of concern"). The communities of concern include people with Medicaid insurance, high school education or less, Hispanic ethnicity, or Black/Asian/Other race (not White race). 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. For three months, 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. At 2 to 3 months after randomization, participants will have a routine CF clinic visit, which may be audio-recorded for evaluation of lung transplant discussion. At 3 months after randomization, there will be a study visit that includes repeated surveys from baseline and the PrepDM Scale. After the 3-month study visit, participants will have access to both educational resources via individual login to the secure research website. At 6-months, there will be a study visit to repeat the surveys. Throughout the 6-months and for a long-term follow up period of 4 years, web analytics will be captured at the individual level to determine usage patterns for both educational resources.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Lung Transplantation, Advanced Lung Disease, Decision Support Tool

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Access to an investigator-designed web-based educational resource with information about lung transplant for three months.
Arm Title
Attention-control
Arm Type
Active Comparator
Arm Description
Access to a publicly available web-based educational resource with information about transplant for three months.
Intervention Type
Behavioral
Intervention Name(s)
Investigator-designed lung transplant education resource (Research Intervention)
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Publicly available transplant education resource (Attention-control)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preparedness for Shared Decision Making (PrepDM) Scale
Description
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.
Time Frame
Measured at the 3-month study visit
Secondary Outcome Measure Information:
Title
Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)
Description
Difference in mean change in confidence-weighted true false (CTF) knowledge score will be measured in the intervention versus control arms of the study using linear mixed models. 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.
Time Frame
Measured at 3-month study visit
Title
Decisional Conflict Scale
Description
Decisional Conflict Scale change will be measured from the baseline study visit to the 3-month 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].
Time Frame
Baseline to 3-month study visit
Title
Likert-scale rating of preparedness to discuss lung transplant (0-4)
Description
Likert rating of preparedness to discuss lung transplant will be measured at each 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 change in Likert-scale rating between the intervention and attention-control arms of the study using linear mixed models.
Time Frame
Measured at 3-month study visit
Title
Patient Health Questionnaire (PHQ-9)
Description
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. The intention-to-treat analysis will compare mean change in PHQ-9 between the intervention and attention-control arms of the study using linear mixed models. Investigators will also determine the proportion with new PHQ-9 score greater than or equal to 10 in each arm.
Time Frame
Measured at 3-month study visit
Title
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Description
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. The intention-to-treat analysis will compare mean change in GAD-7 between the intervention and attention-control arms of the study using linear mixed models. Investigators will also determine the proportion with new GAD-7 score greater than or equal to 10 in each arm.
Time Frame
Measured at 3-month study visit
Other Pre-specified Outcome Measures:
Title
6-month assessment of Preparedness for Shared Decision Making (PrepDM) Scale
Description
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 (6 months of exposure) versus control arms (3 months of exposure) using linear mixed models. PrepDM scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.
Time Frame
Measured at 6-month study visit
Title
6-month assessment for confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)
Description
Change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) will be assessed from baseline to 6-months and from 3-month to 6-month study visits. Mean difference in the change in knowledge score will be compared between study arms for the two time periods (0 to 6 months and 3 to 6 months). Higher scores indicate more knowledge about lung transplant.
Time Frame
Measured at 6-month study visit
Title
6-month assessment for Decisional Conflict Scale
Description
Change in Decisional Conflict Scale will be assessed from baseline to 6-months and from 3-month to 6-month study visits. Mean difference in the change in Decisional Conflict Scale will be compared between study arms for the two time periods (0 to 6 months and 3 to 6 months). Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Time Frame
Measured at 6-months study visit
Title
6-month assessment for Likert-scale rating of preparedness to discuss lung transplant
Description
Evaluate the proportion "Very prepared" at baseline, 3-months and 6-months in the intervention and control arms. Compare proportions across study arms at each time point.
Time Frame
Measured at baseline, 3-month and 6-month study visits
Title
Time spent using the research website
Description
Average time spent using the research website from baseline to 3-months 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 3-month study visit, 2. change in Likert preparedness from baseline to 3-month study visit, 3. change in Decisional Conflict Scale from baseline to 3-month study visit, and 4. mean PrepDM Scale at 3-months.
Time Frame
Baseline to 3-month study visit
Title
Between-arm comparisons of Shared Decision Making Questionnaire (SDM-Q-9)
Description
The analysis will be an intention-to-treat assessment of the difference in mean Shared Decision Making Questionnaire (SDM-Q-9) in the intervention versus attention-control arms of the study at the routine CF Clinic visit using linear mixed models. The SDM-Q-9 scale has a range of (0 to 45), with higher scores indicating higher quality of shared decision making from the patient's perspective. A change in SDM-Q-9 of 12 to 15 has been considered clinically meaningful.
Time Frame
Routine CF Clinic visit during the trial
Title
Between-arm comparisons of Shared Decision Making Questionnaire for physicians (SDM-Q-doc)
Description
The analysis will be an intention-to-treat assessment of the difference in mean Shared Decision Making Questionnaire for physicians (SDM-Q-doc) in the intervention versus attention-control arms of the study at the routine CF Clinic visit using linear mixed models. The SDM-Q-doc scale has a range of (0 to 45), with higher scores indicating higher quality of shared decision making from the physician's perspective.
Time Frame
Routine CF Clinic visit during the trial
Title
Preparedness for Shared Decision Making (PrepDM) Scale among members of communities of concern.
Description
In a prespecified subgroup analysis, investigators will assess the Preparedness for Shared Decision Making (PrepDM) Scale at 3 months within the cohort of participants who are members of communities of concern. This 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 in the subset of individuals who are members of communities of concern (Medicaid insurance, high-school education or less, Hispanic ethnicity, Black/Asian/Other race). Scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.
Time Frame
Measured at 3-month study visit
Title
Decisional Conflict Scale among members of communities of concern.
Description
In a prespecified subgroup analysis, investigators will assess Decisional Conflict Scale change within the cohort of participants who are members of communities of concern (Medicaid insurance, high-school education or less, Hispanic ethnicity, Black/Asian/Other race). Decisional Conflict Scale change will be measured from the baseline study visit to the 3-month 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 in the subset of individuals who are members of communities of concern. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Time Frame
Baseline to 3-month study visit
Title
Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) among members of communities of concern.
Description
In a prespecified subgroup analysis, investigators will assess the difference in mean change from baseline to 3 months in Confidence-weighted true false (CTF) knowledge score will be measured in the intervention versus control arms of the study using linear mixed models within the cohort of participants who are members of communities of concern (Medicaid insurance, high-school education or less, Hispanic ethnicity, Black/Asian/Other race). 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.
Time Frame
Baseline to 3-month study visit
Title
Likert rating of preparedness to discuss lung transplant among members of communities of concern.
Description
In a prespecified subgroup analysis, investigators will assess change from baseline to 3 months in Likert rating of preparedness to discuss lung transplant within the cohort of participants who are members of communities of concern (Medicaid insurance, high-school education or less, Hispanic ethnicity, Black/Asian/Other race). The intention-to-treat analysis will compare mean change in the Likert rating of preparedness to discuss lung transplant between the intervention and control arms of the study in the subset of individuals who are members of communities of concern. Likert rating of preparedness to discuss lung transplant will be measured at each study visit (0=Don't know, 1= Not at all prepared, 2 = A little prepared, 3 = Moderately prepared, 4 = Very prepared).
Time Frame
Baseline to 3-month study visit
Title
Evaluation of CF Clinic audio-recordings and transcripts
Description
Recordings will be listened to by at least two members of the study team for assessment or implicit bias (e.g. speech rate, verbal dominance) and whether the topic of LTx is raised with different frequency among participants from communities of concern.
Time Frame
Routine CF Clinic visit (at least 6 weeks after randomization/until 3-Month Session) during the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of cystic fibrosis FEV1 less than 50% of predicted Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Bartlett, BS, CCRC
Phone
503-583-2869
Email
lrejman@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Ramos, MD, MSc
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
980095
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DeeAnna Serna
Phone
424-381-6507
Email
DSerna@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Grant Turner, MD, MHA, FACP
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Poch, BS
Phone
303-398-1805
Email
PochK@NJHealth.org
First Name & Middle Initial & Last Name & Degree
Milene Saavedra, MD
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Badrun Rahman
Phone
203-430-8391
Email
badrun.rahman@yale.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Koff, MD
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayank Kothari, MBBS, CCRC
Phone
913-588-2881
Email
mkothari@kumc.edu
First Name & Middle Initial & Last Name & Degree
Charles Bengtson, MD
First Name & Middle Initial & Last Name & Degree
Joel Mermis, MD
Facility Name
Maine Health
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Koukos
Phone
207-662-6550
Email
Emma.Koukos@mainehealth.org
First Name & Middle Initial & Last Name & Degree
Edmund Sears, MD
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Noren, RN, BSN, CCRC
Phone
612-625-7995
Email
boer0039@umn.edu
First Name & Middle Initial & Last Name & Degree
Jordan Dunitz, MD
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Hummel, LPN
Phone
513-558-7036
Email
hummelne@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Veronica Indihar, MD
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrienne Dericco, BSN, RN, CCRC
Phone
412-692-8069
Email
adrienne.dericco2@upmc.edu
First Name & Middle Initial & Last Name & Degree
Joseph Pilewski, MD
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Bartlett, BS, CCRC
Phone
503-583-2869
Email
lrejman@uw.edu
First Name & Middle Initial & Last Name & Degree
Kathleen Ramos, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).
IPD Sharing 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.
IPD Sharing 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.
Citations:
PubMed Identifier
30926322
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.
Results Reference
background
PubMed Identifier
36173364
Citation
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.
Results Reference
background

Learn more about this trial

Lung Transplant READY CF 2: A Multi-site RCT

We'll reach out to this number within 24 hrs