Lung Transplant Resources for Education and Decision-making for Your Cystic Fibrosis (READY): A Pilot Randomized Controlled Trial
Phase: NA
Conditions: Cystic Fibrosis
Sponsor: University of Washington

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UNIVERISTY OF WASHINGTON 
Clinical Research Protocol 
 
Protocol Number: 
STUDY00011578 
Version Date: 
3/29/2023 
Sponsor-Investigator: 
Kathleen Ramos-Alexander, MD MSc  
1959 NE Pacific Street 
Seattle, WA 98195-6522 
Funding Organization: 
National Institutes of Health (NIH) - The National Heart, 
Lung, and Blood Institute (NHLBI) 
Site Investigator:  
Kathleen Ramos-Alexander, MD MSc 
 
Ramoskj@uw.edu 
 
Approval: 
 
 
 
PI or Sponsor Signature (Name and Title)  
 
Date 
This confidential information about an investigational product is provided for the exclusive use of 
investigators of this product and is subject to recall at any time.  The information in this document 
may not be disclosed unless federal or state law or regulations require such disclosure.  Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a 
need to know, with the obligation not to further disseminate this information.   
 
 
 

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TABLE OF CONTENTS 
 
1.0 
PURPOSE OF THE INVESTIGATION .................................................... 9 
1.1. Name of intervention ............................................................................. 9 
1.2. Intended use of the intervention .......................................................... 9 
1.3. Objectives of the clinical investigation ............................................... 9 
1.3.1. 
Primary objective ................................................................................................................. 9 
1.3.2 
Secondary objective(s). ......................................................................................................... 9 
1.4 
Anticipated duration of the clinical investigation ...................................... 9 
2.0 
CLINICAL PROTOCOL ........................................................................ 10 
2.1 
Protocol number and title ....................................................................... 10 
2.3 
Study design .......................................................................................... 10 
2.3.1 
General study design ........................................................................................................... 10 
2.3.2 
Study design schematic ....................................................................................................... 10 
2.4 
Subject selection ................................................................................... 10 
2.4.1 
General characteristics of the proposed subject population(s) ............................................ 10 
2.4.2 
Anticipated number of research subjects ............................................................................. 11 
2.4.3 
Inclusion criteria ................................................................................................................... 11 
2.4.4  
Exclusion criteria ................................................................................................................. 11 
2.5 
Study procedures .................................................................................. 11 
2.5.1 
Screening procedures.......................................................................................................... 11 
2.5.2 
Study procedures ................................................................................................................ 12 
2.5.3 
Allocation to treatment arms ................................................................................................ 12 
2.5.6 
Withdrawal of subjects ......................................................................................................... 13 
2.5.8 
Procedures to assess safety ................................................................................................ 13 
2.5.9 
Schedule of study visits and compensation ......................................................................... 14 
2.6 
Study outcome evaluations ................................................................... 14 
2.6.1 
Study endpoints ................................................................................................................... 14 
2.6.2 
Sample size determination .................................................................................................. 15 
2.6.3 
Statistical analysis plan ........................................................................................................ 15 
2.6.4 
Data and Safety Monitoring Committee ............................................................................... 16 
3.0 
RISK ANALYSIS ................................................................................... 16 
3.2 
Adverse event reporting ........................................................................ 17 
3.2.1 
Adverse event definitions ..................................................................................................... 17 
3.2.3  
Recording and assessment of adverse effects .................................................................... 18 
3.2.5 
Causality and severity assessment ..................................................................................... 18 
3.2.6 
Reporting adverse effects to the responsible IRB ................................................................ 20 
5.0 
MONITORING PROCEDURES ............................................................. 20 

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7.0 
INFORMED CONSENT ......................................................................... 20 
8.0 
IRB INFORMATION .............................................................................. 20 
10.0 
ADDITIONAL RECORDS AND REPORTS .......................................... 21 
10.1 Data handling and record-keeping ........................................................ 21 
10.2 Record maintenance and retention ....................................................... 21 
APPENDIX 1: Interview Guides ....................................................................... 22 
APPENDIX 2: Consent Form ............................................................................ 28 
References ........................................................................................................ 32 
 
 

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LIST OF ABBREVIATIONS 
AE 
Adverse Event 
CF 
Cystic Fibrosis 
CFFPR 
Cystic Fibrosis Foundation Patient Registry 
CFTR 
Cystic fibrosis transmembrane conductance regulator 
DSMB 
Data Safety Monitoring Board 
FDA 
Food and Drug Administration 
FEV1 
Forced expiratory volume in 1 second 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
Informed Consent Form 
IEC 
Independent Ethics Committee 
IPDAS 
International Patient Decision Aid Standards 
IRB 
Institutional Review Board 
LTx 
Lung Transplant 
PI 
Principal Investigator 
PrepDM 
Preparation for Decision Making Scale 
SAE 
Serious Adverse Event 
ToT 
Take on Transplant 
UNOS 
United Network for Organ Sharing 
 
 
 

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PROTOCOL SYNOPSIS 
TITLE 
Lung Transplant READY (Resources for Education and Decision-
making for Your CF) Pilot Study 
SPONSOR 
University of Washington 
FUNDING 
ORGANIZATION 
National Institutes of Health (NIH) - The National Heart, Lung, and 
Blood Institute (NHLBI) 
NUMBER OF SITES 
1 
SPECIFIC AIMS 
1. Determine whether Take on Transplant (online educational tool) 
improves patient preparedness for lung transplant (LTx) 
discussions using a pilot study that employs randomized, 
controlled, rollover trial design. 
2. Longitudinally assess time spent using Take on Transplant 
through patient-level analysis of tool usage and identify 
predictors of increased usage. 
RATIONALE 
1. Despite therapeutic advances in CF care, many CF patients will 
go on to require LTx, including individuals already affected by 
advanced lung disease, those for whom highly effective CFTR 
modulators are not available or not tolerated, and for some 
despite CFTR modulators. Individuals with CF seek information 
about LTx and feel underprepared for the LTx decision. Use of a 
decision support tool or online educational materials about LTx 
may improve the quality, efficiency and effectiveness of LTx 
education in CF clinic and empower patients to engage in 
discussions about this complex medical treatment by increasing 
their sense of preparedness for the discussion. Feasibility must be 
established. The Preparation for Decision Making (PrepDM) 
Scale[1] is a validated measure of preparedness for decision 
making with known variance and high internal consistency (a 
0.92-0.96), but it has not been studied in the CF population. 
Individual questions within the PrepDM Scale are informative 
and reflect IPDAS process measures[2, 3]. It is unclear whether 
there are ceiling or floor effects for particular questions within 
the PrepDM scale when evaluating a LTx decision support tool in 
the CF population, and the proposed pilot study utilizing a test-
retest approach will establish preliminary means standard 
deviations, and reliability in this population. A prior decision aid 
for LTx in CF was shown to decrease decisional conflict in a 
randomized clinical trial and we will assess change in the 
Decisional Conflict Scale as a secondary endpoint.[4] 
2. Engagement with Take on Transplant over time allows users to 
explore the content, potentially viewing more ‘CF Stories’, 
‘Resource Library’, and ‘Frequently Asked Questions’ content 
and more interactions with ‘My CF Stage’. Shared decision-
making may naturally appeal to and benefit individuals who seek 
out health-related information, feel empowered to advocate for 
their own needs, and have more advanced educational attainment, 
while potentially increasing disparities for patients who are 
already disadvantaged. Shared decision making interventions 

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tailored to disadvantaged groups can increase knowledge, 
informed choices and participation in decision-making, and 
reduce decisional conflict for patients in disadvantaged groups. 
We will obtain an individualized, longitudinal view of the 
participants’ usage data as they interact with Take on Transplant, 
including page views and time spent per page, to characterize 
usage patterns over the 1 month. Characterization of different use 
patterns among individuals with disadvantaged backgrounds 
(oversampled in Aim 1) could inform enhancements to t Take on 
Transplant to improve usage and acceptability by patients with 
limited access to LTx. Carefully assessing health literacy with the 
TOFHLA[5], an instrument that measures health-related reading 
comprehension and numeracy, could lead to understanding of 
mechanisms underlying differential use of Take on Transplant 
and change in PrepDM Scale. 
STUDY DESIGN 
This is a prospective, multi-center, randomized, controlled single-
blind rollover pilot study 
PRIMARY OBJECTIVE 
To test feasibility and efficacy of Take on Transplant to improve 
patient preparedness for decision making about LTx. 
SECONDARY 
OBJECTIVES 
• 
Understand LTx knowledge gained.  
• 
Assess changes in decisional conflict. 
• 
Measure changes in preparedness for LTx discussions. 
• 
Assess changes in depression and anxiety symptoms. 
• 
Longitudinally characterize time spent using Take on 
Transplant through analysis of patient-level usage data and 
determine whether ongoing use of the tool is associated with 
maintaining or increasing ratings of preparedness at 1-month.  
• 
Identify baseline demographic and health literacy predictors of 
increased Take on Transplant usage  
• 
Analyze interview transcripts to inform revision of Take on 
Transplant prior to a large randomized controlled trial  
NUMBER OF SUBJECTS 
~50 
SUBJECT SELECTION 
CRITERIA 
Inclusion Criteria:  
• 
Diagnosis of CF 
• 
Adult, greater than or equal to 18 years of age 
• 
Able to read and understand English, but English can be a second 
language 
• 
Forced expiratory volume in one second (FEV1) less than 50% 
predicted 
Exclusion Criteria:    
• 
Previously underwent LTx 
INTERVENTION ARM 
Take on Transplant – Educational website that couples real-life CF 
patient experiences of LTx in the form of personal narratives with up-
to-date, CF-specific, and guideline-based medical information about 
LTx. 
CONTROL ARM 
UNOS.org – Educational website that contains general information 
about transplantation (all organs). 

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DURATION OF SUBJECT 
PARTICIPATION AND 
DURATION OF STUDY 
Subjects will be on study for up to 4 weeks with a total of three study 
sessions: Introduction Session, 2-Week Follow-up Session, and 4-
Week Follow-up Session. 
PRIMARY ENDPOINT 
The co-primary endpoint is feasibility, which will be defined as 
successful by 90% of enrolled participants completing the 2-week 
study visit. 
 
The co-primary endpoint is an intention-to-treat assessment of the 
difference in mean PrepDM Scale in the intervention versus control 
arms of the study at the 2-week study visit. 
SECONDARY ENDPOINTS • 
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.  
• 
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].  
• 
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. 
• 
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. 
• 
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. 
• 
Longitudinally characterize time spent using Take on 
Transplant through analysis of patient-level usage data. Average 

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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 CTF knowledge about LTx (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. 
• 
The PrepDM Scale will be measured for all participants with 
respect to Take on Transplant 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. 
• 
Identify baseline demographic and health literacy predictors of 
increased tool usage.  
 
 
 
 

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1.0 
PURPOSE OF THE INVESTIGATION 
1.1. 
Name of intervention 
Take on Transplant (ToT): an educational website that couples real-life CF patient 
experiences of LTx in the form of personal narratives with up-to-date, CF-specific, and 
guideline-based medical information about LTx. 
1.2. 
Intended use of the intervention 
ToT addresses patient-identified knowledge gaps and provides personalized educational 
content to help CF patients prepare for LTx discussions and decisions. 
1.3. 
Objectives of the clinical investigation 
1.3.1. Primary objective 
The primary research objectives are to pilot test feasibility and efficacy of ToT to 
improve patient preparedness for decision making about LTx. The co-primary endpoint is 
feasibility, which will be defined successful by 90% of enrolled participants completing 
the 2-week study visit. A co-primary endpoint is an intention-to-treat assessment of the 
difference in mean PrepDM Scale in the intervention versus control arms of the study at 
the 2-week study visit. 
1.3.2 Secondary objective(s). 
 
The secondary objectives are to: 
• Understand LTx knowledge gained.  
• Assess changes in decisional conflict. 
• Measure changes in preparedness for LTx discussions. 
• Assess changes in depression and anxiety symptoms. 
• Longitudinally characterize time spent using ToT through analysis of patient-level 
usage data and determine whether ongoing use of the tool is associated with 
maintaining or increasing ratings of preparedness at 1-month.  
• Identify baseline demographic and health literacy predictors of increased ToT 
usage  
• Analyze interview transcripts to inform revision of ToT prior to a large 
randomized controlled trial  
1.4 
Anticipated duration of the clinical investigation 
 
The total duration of the clinical investigation is expected to be approximately 4 weeks: 2 
weeks randomized to one arm of the study and 2 additional weeks with access to both 
websites.  

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2.0 
CLINICAL PROTOCOL 
2.1 
Protocol number and title  
 
STUDY00011578: Lung Transplant READY (Resources for Education and Decision-
making for Your CF) Pilot Study 
2.3 
Study design 
2.3.1 General study design 
This is a prospective, multi-center, randomized, controlled single-blind rollover pilot 
study 
2.3.2 Study design schematic 
 
Figure 1: The study will last four weeks with a total of three study sessions including the 
following: Baseline Session (V1), 2-Week Follow-up Session (V2), and 4-Week Follow-
up Session (V3).  
 
2.4 
Subject selection 
2.4.1 General characteristics of the proposed subject population(s) 
Study subjects will be volunteer CF patients, age 18 years or above with FEV1 of less 
than 50% predicted and have not yet undergone LTx. Approximately 50 subjects who 
give informed consent, meet all of the inclusion criteria and none of the exclusion criteria 
will be enrolled in the study. 
LTx is an option for treating end-stage lung disease in CF. The population of CF patients 
with FEV1 less than 50% represents a subset of individuals living with CF who are closer 
to the stage where LTx might become a viable option. These patients are the ones most 
likely to benefit from access to ToT, making them a relevant and representative group for 
this investigation. Additionally, individuals with low socioeconomic status have 
historically limited access to lung transplant and worsened outcomes. We aim to include 
individuals considered to be from “communities of concern” as a minimum of 30% of our 
study population. The “communities of concern” will be individuals who are racially 
Study schema for pilot RCT evaluating effect of ToT on patient 
preparedness for lung transplant discussions
CF diagnosis
FEV1 <50% predicted
Age ≥ 18 years
Randomize
Roll over to 
both websites
4 weeks
2 weeks
V1
Screening
V2*
V3
ToT
and
UNOS
Take on Transplant (ToT)
UNOS

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minoritized, Hispanic ethnicity, Medicaid insurance status (primary or secondary), and/or 
a high school education or less. 
2.4.2 Anticipated number of research subjects 
The study will enroll approximately 50 adults with CF and an FEV1<50% predicted, 
without prior LTx. Individuals will be recruited from the University of Washington and 
collaborating adult CF centers across the United States. 
We anticipate 90% (45 participants) of enrolled participants will complete the 2-week 
study visit.  
2.4.3 Inclusion criteria 
1. Diagnosis of CF 
2. Adult, greater than or equal to 18 years of age 
3. Able to read and understand English, but English can be a second language 
4. FEV1 <50% predicted 
2.4.4  Exclusion criteria 
1. Previously underwent LTx  
2.5 
Study procedures 
2.5.1 Screening procedures 
Research coordinators and lead researchers at the University of Washington (UW) Adult 
Cystic Fibrosis Clinic will conduct eligibility screening by utilizing the Cystic Fibrosis 
Patient Registry database (PortCF), medical records, and clinic schedules. Eligible 
individuals will be contacted before their clinic appointments, with study information 
provided via phone, and consent forms offered through mail or email.  
 
Additionally, in STUDY0007475 approved by the UW HSD IRB, participants will be 
distributed a screening survey which provides the ability to voluntarily opt-in to being 
contacted by the UW research team for additional opportunities to participate in related 
studies. Collaborators at external sites will screen their local PortCF registry for 
participants meeting eligibility criteria and advertise the availability of the screening 
survey. CF patients consent separately to participate in the CFF registry which allows for 
screening for research study eligibility. The screening survey will be advertized to 
eligible participants at collaborating CF centers which allows for the recruitment of 
participants from within and outside of the UW to enable generalizable results. Per HHS 
guidelines, collaborating sites were considered not engaged in the research and did not 
require site-IRB approval to advertise the availability of this screening survey. 
 
Individuals recruited from STUDY0007475 who opt-in to being contacted by the UW 
research team will be contacted to participate in this study. Study staff at the UW will call 
the patient and provide detailed information about the study. UW study staff will provide 
informed consent over the phone and the patient will provide verbal consent to 
participate. The UW research coordinator will mail or email copies of the consent form 
for participants to keep for their records. 

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2.5.2 Study procedures 
The study will last four weeks with a total of three study sessions including the 
following: Baseline Session (V1), 2-Week Follow-up Session (V2), and 4-Week Follow-
up Session (V3). All study visits will occur remotely via Zoom videoconferencing. 
 
Study procedures will include the following: 
 
Surveys – Participants will be asked to complete surveys at each study session. Surveys 
may consist of the following instruments: PrepDM Scale[1], Decisional Conflict 
Scale[6], Shortened Test of Functional Health Literacy in Adults (S-TOFHLA)[5], 
questions from the Health Information National Trends Survey (HINTS)[7], assessment 
of health numeracy[8], GAD-7[9], an investigator-designed lung transplant knowledge 
assessment, System Usability Scale (SUS)[10], general satisfaction scale, Hospital 
anxiety and depression scale (HADS)[11], PHQ-9[12], Cystic Fibrosis Questionnaire – 
Revised (CFQ-R)[13], Acceptability of Intervention Measure (AIM)[14], Intervention 
Appropriateness Measure (IAM)[14], and Feasibility of Intervention Measure (FIM)[14]. 
Each set of surveys will take approximately 15-20 minutes to complete. 
 
Interview – Interviews will take place at each study session, via Zoom teleconferencing. 
Interviews will take approximately 30-60 minutes. All interviews will be recorded and 
transcribed for qualitative analyses. The research team will use an interview guide with 
directed questions discussing topics including shared decision making and general 
feedback on ToT and the attention control website (unos.org) including perceptions of 
and experience with using the resources, and any barriers to ongoing use of the research 
website. Structured interviews on the day of the baseline session may also address 
preparedness to discuss LTx, ask participants to describe the most impactful aspect of the 
research websites, and summarize the ‘CF Story’ that was most meaningful.  
 
Research website – Participants will be introduced to the research website during the 
baseline session (V1). The research website is a portal that will contain links to two 
interventions including ToT and an attention control (unos.org). Before accessing the 
research website during the baseline session, participants will be randomized to first 
receive access to only one of the two websites through the portal. The research website 
will track website usage (i.e. time spent, content accessed, etc.) for all study participants 
for both ToT and unos.org. Once the participant completes the 2-week study visit (V2), 
the portal will contain access to both ToT and unos.org for the remainder of the study (2 
more weeks).  
2.5.3 Allocation to treatment arms 
Participants will be randomized 1:1 to either the intervention (“Take on Transplant”) or 
the attention control (unos.org), stratified by FEV1 <30% versus 30-50%. Participants 
will be given access to their assigned website via the research website portal for two 
weeks. After the 2-week session interview, access to the opposite arm assignment will be 
unlocked and participants will have unlimited access to both the intervention (ToT) and 
the attention control (Unos.org).  

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2.5.6 Withdrawal of subjects  
Subjects can withdraw at any point in time. They will be given contact information of the 
study staff if they decide they would like to withdraw or if they have any questions 
pertaining to their involvement in the study. 
2.5.8 Procedures to assess safety 
We will assess safety using the PHQ-9[12] and GAD-7[9] survey assessments. 
 
The topic of LTx can be distressing to some with CF. There could be a risk of increasing 
depression symptoms and/or suicidality through the introduction of LTx education in this 
patient population. The PHQ-9 and GAD-7 surveys will be administered at the baseline 
visit (V1) and at both study visits (V2, V3) after patients gain access to ToT or unos.org 
to assess whether introduction of transplant education has a negative psychological 
impact on patients including an increase in anxiety, depression, and/or distress. Patients 
with an abnormal PHQ-9 or GAD-7 will be allowed to enroll in the study because 
depression and anxiety are prevalent in advanced CF lung disease. We hypothesize use of 
ToT may actually lessen patients’ depression and/or anxiety with time.   
 
The interviewer (UW research staff) will review PHQ-9 responses immediately after 
responses are submitted. The interviewer will also probe, via discussion with the 
participant, for any indicators of negative psychological impacts of use of the decision 
support tool. If possible suicidality is endorsed on the PHQ-9 (positive response to 
question #9), the interviewer will provide a subject who endorses possible suicidality 
with the National Suicide Hotline phone number and will inform them to call the 
National Suicide Hotline if they need help prior to receiving the call from Dr. Ramos or 
another study physician about the PHQ-9 results. Additionally, the PI, or another study 
physician, will be notified immediately after the abnormal PHQ-9 result is entered. The 
patient’s CF clinician will be contacted directly immediately via secure communication, 
by the PI, in the setting of possible suicidality. The PI or another study physician will call 
the patient within 8 hours of a PHQ-9 response that indicates suicidality and the 
Columbia-Suicide Severity Rating Scale (C-SSRS) screen with triage points for primary 
care will be completed. The C-SSRS response protocol will be followed and a safety 
contract will be established with the patient by the physician by phone. Dr. Ramos, and 
the other study physicians, are trained physicians, practicing medicine in populations 
with advanced diseases, end of life concerns, and high rates of mental illness. Dr. Ramos 
has clinical experience with patients who report suicidality and has the resource of a 
trained CF mental health specialist for complex cases.  

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2.5.9 Schedule of study visits and compensation 
 
2.6 
Study outcome evaluations 
2.6.1 Study endpoints 
Primary endpoints 
• The co-primary endpoint is feasibility, which will be defined as successful by 
90% of enrolled participants completing the 2-week study visit. 
 
• The co-primary endpoint is an intention-to-treat assessment of the difference in 
mean PrepDM Scale in the intervention versus control arms of the study at the 2-
week study visit. 
 
Secondary endpoints 
• 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.  
• 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].  
• 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. 
• 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 

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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. 
• 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. 
• Longitudinally characterize time spent using Take on Transplant through analysis 
of patient-level usage data. 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 
CTF knowledge about LTx (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. 
• The PrepDM Scale will be measured for all participants with respect to Take on 
Transplant 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. 
• Identify baseline demographic and health literacy predictors of increased tool 
usage. 
2.6.2 Sample size determination 
This will be a pilot and feasibility study, and we anticipate 90% of 50 enrolled 
participants (95% CI 79-96%) will complete the 2-week study visit (V2).     
2.6.3 Statistical analysis plan 
Primary endpoints 
The co-primary endpoint is feasibility, which will be defined successful by 90% of 
enrolled participants completing the 2-week study visit (V2). Descriptive statistics will be 
used to determine whether this threshold was met.  
 
The co-primary endpoint of difference in PrepDM scale score (Difference = intervention 
– control) at 2-weeks will be assessed using linear regression, with statistical significance 
level set at 2-sided alpha <0.05. 
 
Secondary endpoints 
Continuous secondary endpoints will be assessed using linear regression, with statistical 
significance level set at 2-sided alpha <0.05. 
 
Categorical secondary endpoints will be assessed using Pearson's chi-squared test of 
independence, with statistical significance level set at 2-sided alpha <0.05. 
Graphical methods and descriptive statistics will be used to evaluate differences in usage 
during the 4 weeks of access across subsets of the cohort with different socioeconomic 

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status (based on insurance status, income, education level) and health literacy (based on 
S-TOFHLA). Exploratory models will test for a dose-response relationship by 1) time 
spent using the tool (uses/week) and 2) number of ‘CF Stories’ viewed and PrepDM 
Scale at 2-week and 4-week study visits. Linear regression may be used to determine 
whether predictors of increased time spent using the tool can be identified from baseline 
demographics and questionnaire results. Subgroup analyses will compare changes across 
instruments among participants with adequate health literacy to those with inadequate or 
marginal health literacy. We will also perform subgroup analysis for patients with FEV1 
<30% predicted.  
These data will inform the feasibility of completing a larger, multicenter, randomized 
controlled trial of ToT and will inform duration of the larger trial. 
2.6.4 Data and Safety Monitoring Committee 
A data safety monitoring board (DSMB) will not be necessary for this research protocol. 
Research in this pilot study poses no more than minimal risk to participants. There will be 
no statistical monitoring to determine whether the clinical trial should be terminated for 
reasons of safety. There will be no interim evaluations for efficacy. There are no planned 
stopping rules for futility since this is a pilot study. Safety monitoring will focus on 
ensuring participants are not experiencing any significant or unexpected psychological 
distress and that they are satisfied with the study intervention and interviews. The 
Principal Investigator will provide ongoing observation for psychological distress as 
reported in satisfaction surveys or during interviews. The PI will monitor for Adverse 
Events related to the study, but there is a very low risk for adverse events with the 
proposed intervention. Dr. Ramos has three years of experience as a medical monitor for 
the Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, 
and is well-qualified to review and make a determination of relatedness of a serious 
adverse event (SAE) to the study intervention. 
3.0 
RISK ANALYSIS 
3.1 
Anticipated risks 
Subjects may be exposed to minimal risks associated with the conduct of this study. 
 
Psychological risks: Given the sensitive nature of LTx as a treatment option for CF, it is 
possible that patients may experience psychological distress from reading about 
transplant, especially in cases where CF patients have died after LTx. We have worked to 
mitigate this risk by allowing participants to moderate the amount of information they 
read about particular patient stories or ‘Resource Library’ content. Specifically, we have 
applied labels to ‘CF Stories’ with a “bad outcome” or “death,” which are visible prior to 
entering the story. Additionally, over the course of a participant’s involvement in this 
research study we will monitor mental health by administering mental health 
assessments, including the PHQ-9 survey. It is possible that a participant may experience 
psychological discomfort by completing these assessments. To protect a participant’s 
wellbeing, if abnormal results are reported in the PHQ-9 the UW research team will 
notify their CF doctor for follow-up care. 

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There is no proven benefit of ToT at this time, but a prior (now outdated) decision aid for 
LTx in CF showed a reduction in decisional conflict and we hypothesize that the 
proposed intervention will increase preparedness for decision making and decrease 
decisional conflict related to LTx. Further, this pilot study will provide important 
feedback to optimize ToT for future users. 
3.2 
Adverse event reporting  
3.2.1 Adverse event definitions 
An adverse event (AE) is any untoward medical occurrence in a clinical investigation of a 
patient administered a pharmaceutical product or undergoing an investigational procedure 
that does not necessarily have a causal relationship with the treatment or procedure. An 
AE is therefore any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom or disease temporally associated with the administration of an 
investigational product or procedure, whether or not related to that investigational 
product. An unexpected AE is one of a type not identified in nature, severity, or 
frequency in the currently accepted risk profile for the treatment or procedure. 
An unanticipated problem (UP) is defined as any incident, experience, or outcome that 
meets all of the following criteria: 
1. unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
2. related or possibly related to participation in the research (in this guidance 
document, possibly related means there is a reasonable possibility that the 
incident, experience, or outcome may have been caused by the procedures 
involved in the research); and 
3. suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
An SAE is defined as any untoward medical occurrence that at any level of procedural 
intensity: 
1. Results in death 
2. Is considered life threatening (i.e., in the view of the Investigator the adverse 
experience places the patient or participant at immediate risk of death from the 
response, as it occurred; it does not include a reaction that, had it occurred in a 
more severe form, might have caused death) 
3. Requires hospital admission or prolongation of an existing hospitalization 
4. Results in persistent or significant disability/incapacity (i.e., a substantial 
disruption of a person’s ability to conduct normal life functions) 
5. Is an important medical event (i.e., when based upon appropriate medical 
judgment, the adverse experience may jeopardize the patient or participant and 

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may require medical or surgical intervention to prevent one of the above listed 
outcomes) 
For the purposes of the proposed study, participant report of possible suicidality on the 
PHQ-9 is an immediately reportable AE, even if it is not an SAE. An alternative 
approach would be to utilize the PHQ-8 (which excludes the question about suicide), but 
it is important to understand whether there is a risk of increasing suicidality through the 
introduction of LTx education in this patient population. Avoiding the question in our 
study will not prevent the thoughts/feelings from occurring and we determined that it is in 
the interest of patient safety to include the question about suicidality and have a plan in 
place for responding in the case of this AE of special interest. 
3.2.3  Recording and assessment of adverse effects 
The Principal Investigator and/or research team staff will probe, via discussion with the 
participant, for the occurrence of AEs/UPs during each participant visit/call and record 
the information in the study’s records. AEs will be described by duration (start and stop 
dates and times), severity, outcome, treatment and relation to study procedure, or if 
unrelated, the cause.  
 
All observed or volunteered adverse events (serious or non-serious) and abnormal test 
findings, regardless of treatment group, if applicable, or suspected causal relationship to 
the investigational device or, if applicable, other study treatment or diagnostic product(s) 
will be recorded in the subjects’ case histories.  For all adverse effects, sufficient 
information will be pursued and/or obtained so as to permit 1) an adequate determination 
of the outcome of the event (i.e., whether the effect should be classified as a serious 
adverse event) and; 2) an assessment of the casual relationship between the adverse effect 
and the investigational device or, if applicable, the other study treatment or diagnostic 
product(s).     
3.2.5 Causality and severity assessment 
The National Cancer Institute’s Common Terminology Criteria for Adverse Events 
(CTCAE) Version 4.03, as modified for CF, will be used to assess and grade AE severity, 
including laboratory abnormalities judged to be clinically significant. If the experience is 
not covered in the modified criteria, the guidelines shown in Table 1 below will be used 
to grade severity. It should be pointed out that the term “severe” is a measure of intensity 
and that a severe AE is not necessarily serious. 
Table 1. Adverse Event Severity Grading 

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Severity (Toxicity 
Grade) 
Description 
Mild (1) 
Transient or mild discomfort; no limitation in activity; no 
medical intervention or therapy required. The participant may be 
aware of the sign or symptom but tolerates it reasonably well. 
(e.g. fatigue during study visit) 
Moderate (2) 
Mild to moderate limitation in activity, no or minimal medical 
intervention/therapy required. (e.g. psychological discomfort 
during study visit that may lead to crying or other emotional 
displays) 
Severe (3) 
Marked limitation in activity, medical intervention/therapy 
required, hospitalizations possible. (e.g. profound symptoms of 
anxiety or depression prompting hospitalization) 
Life-threatening 
(4) 
The participant is at risk of death due to the adverse experience 
as it occurred. This does not refer to an experience that 
hypothetically might have caused death if it were more severe. 
(e.g. suicidality that leads to a suicide attempt) 
The relationship of an AE to the study procedure should be assessed using the following 
the guidelines in Table 2. 
Table 2. Adverse Event Relationship to Study Procedure 
Relationship 
to study procedure 
Comment 
Definitely 
Previously known risk of procedure; or an event that follows a 
reasonable temporal sequence from performance of the 
procedure/testing; that follows a known or expected 
physiologic response to the procedure; that is confirmed by 
stopping or reducing the intensity of the procedure; and that is 
not explained by any other reasonable hypothesis. 
Probably 
An event that follows a reasonable temporal sequence from 
performance of the procedure; that follows a known or 
expected physiologic response to the procedure; that is 
confirmed by stopping or reducing the intensity of the 
procedure; and that is unlikely to be explained by the known 
characteristics of the participant’s clinical state or by other 
interventions. 
Possibly 
An event that follows a reasonable temporal sequence from 
performance of the procedure; that follows a known or 
expected physiologic response to the procedure; but that could 
readily have been produced by a number of other factors. 
Unrelated 
An event that can be determined with certainty to have no 
relationship to the study procedure. 
 

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3.2.6 Reporting adverse effects to the responsible IRB 
All unanticipated problems that are SAEs (whether procedure related or not) that occur 
within 48 hours of a study visit will be documented and reviewed by the Investigator 
within 24 hours. SAEs that occur not within 48 hours of a study visit will be captured 
through patient’s self-report at the next study visit, but will not be reported. All SAEs 
within 48 hours of a study visit will be sent the UW IRB within 24 hours. Reporting of 
unanticipated problems that are SAEs to the IRB will be performed by the Investigator in 
accordance with the standard operating procedures and policies. Adequate documentation 
will be provided showing that the IRB was properly notified. All episodes of reported 
suicidality documented on PHQ-9 administered during study visits, or patient report of 
suicidality between study visits, will be reported to the UW IRB within 24 hours. 
Additionally, the patient’s CF clinician will be contacted directly immediately via secure 
communication, by the PI (Dr. Ramos), and a study physician will establish a safety 
contract with the patient by phone in the interim within 8 hours of becoming aware of an 
abnormal result. 
5.0 
MONITORING PROCEDURES 
Study staff at the University of Washington will be responsible for monitoring for data 
accuracy and completeness. 
7.0 
INFORMED CONSENT 
Once an eligible participant is identified from UW or at external sites via REDCap 
screening survey, a UW research coordinator will call the patient and verbal consent will 
be obtained. Before obtaining verbal consent, UW study staff will review the consent 
form with participants, allow time to answer any questions, and ensure participants 
demonstrate an understanding of study requirements and agree to participate.  
Study staff will ask the subject if they fully understand everything that was explained in 
the consent documents and if they have any questions. Consent documents will be 
emailed or mailed to subjects if additional information is requested before verbal consent 
is obtained. Subjects will also be provided with a copy of the consent document for their 
records which includes study staff contact information if they have additional questions. 
Before obtaining verbal consent, all subjects will be told that this research study is 
voluntary and they are able to withdraw at any time. They will be given contact 
information of the study staff if they decide they would like to withdraw or if they have 
any questions pertaining to their involvement in the study. 
8.0 
IRB INFORMATION 
This pilot RCT was reviewed and approved by the University of Washington Human 
Subject’s Division IRB. Collaborating institution who distributed screening surveys for 
recruitment purposes were considered not engaged per HHS guidelines and did not 
require additional IRB approval from their local IRBs.  

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Any documents that the IRB may need to fulfill its responsibilities (such as protocol, 
protocol amendments, consent forms, information concerning patient recruitment, 
payment or compensation procedures, or other pertinent information) will be submitted to 
the IRB.  The IRB’s written unconditional approval of the study protocol and the 
informed consent form will be in the possession of the Investigator before the study is 
initiated.   
Protocol and/or informed consent modifications or changes may not be initiated without 
prior written IRB approval except when necessary to eliminate immediate hazards to the 
patients or when the change(s) involves only logistical or administrative aspects of the 
study.  Such modifications will be submitted to the IRB and written verification that the 
modification was submitted and subsequently approved should be obtained.   
The IRB must be informed of revisions to other documents originally submitted for 
review; new information that may affect adversely the safety of the patients of the 
conduct of the study; an annual update and/or request for re-approval; and when the study 
has been completed. 
10.0 ADDITIONAL RECORDS AND REPORTS   
10.1 Data handling and record-keeping 
All study data will be maintained using REDCap. Only authorized individuals will be 
permitted to access study data. 
All investigators and staff involved will have completed human subjects' protection 
training, have HIPAA training, and be bound by the agreement of confidentiality. A copy 
of the protocol will be given to all study team members and regular meetings will be held 
to discuss matters including questions and responsibilities relating to the study. All study 
databases will be maintained at the UW on password protected computers and backed up 
to an encoded password protected file. All procedures for the handling and analysis of 
data will be conducted using good clinical practices meeting FDA guidelines for the 
handling and analysis of data for clinical trials. 
10.2 Record maintenance and retention  
This study will comply with records retention periods set by Washington State.  
 
 

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APPENDIX 1: Interview Guides 
 
Overall Research Questions:   
1. In what ways did the website(s) affect perceptions of preparedness to discuss transplant? 
2. How well does ToT (stories/Resource Library/FAQ) or UNOS address the information needs 
of people living with CF? What information/information sources were meaningful, impactful, 
and salient (ToT or UNOS)?  
3. What could be potential barriers and facilitators to using ToT or UNOS? What is the 
acceptability and feasibility of ToT (or UNOS)? How could ToT be improved? 
Intro Session (prior to randomization) – 60-minute session 
Goals of interview:  
• 
Understand prior discussions and current understanding of LTx before exposure to 
the website(s) - what went well/not well during prior LTx discussions; has the 
participant thought about transplant; how could understanding be improved 
(information needs)? 
• 
Questions to complement survey responses - explore baseline preparedness for 
discussions; could the participant decide about LTx already? 
• 
Introduction to research website - 10 minute maximum plus demo video 
1. Can you tell me about a time when you discussed lung transplant with your CF 
doctor?  
 
If transplant has been discussed: 
• 
Who initiated the conversation? If the patient initiated, why? If the doctor 
initiated, how did you react? 
• 
What were some of the emotions you felt during the conversation?  
• 
Did you feel prepared to have the conversation? Why/why not? 
• 
Was anyone else present during the conversation? If yes, was it useful to 
have someone with you? If not, would you have preferred someone to be 
there? 
• 
What could have made the conversation better? 
If transplant has not been discussed:  
• 
Has there ever been a time you wanted to discuss lung transplant with 
your doctor, but didn’t? If yes, what stopped you from initiating the 
conversation? 
• 
When do you think would be the right time to talk to your doctor about 
lung transplant? 
• 
CF Foundation guidelines are now recommending people have annual 
conversations about transplant with their doctor once someone’s FEV1 is 
<50% predicted? In what ways might it be beneficial to talk about 
transplant early on? Could there be any harms or problems from 
discussing it too early? 

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2. Can you tell me about a time when you discussed lung transplant with a loved one 
(e.g friend or family member, etc.)? 
 
If transplant has been discussed: 
• 
How was this conversation similar or different from a conversation you 
might have with your doctor? 
• 
How might you benefit from having these conversations with your loved 
one? 
 
If transplant has not been discussed: 
• 
If your loved one talked with you about lung transplant, how might you 
react? 
• 
What might prompt you to talk about transplant with a loved one? 
3. Do you know anyone who has received a lung transplant?  
• 
If yes, how has knowing about transplant from recipients affected how you 
think of it? 
• 
If no, how might hearing stories from people with CF who have 
undergone transplant affect how you think of it? 
4. Can you tell me about any research you have done on lung transplant (for example, 
reading online or talking to others about it)? 
 
If prior research: 
• 
What prompted you to look into lung transplant? 
• 
How was your experience looking for information about lung transplant? 
• 
Did your doctor recommend or provide any resources to you?  
• 
How did you discover other information sources?  
• 
Did you trust the information you found? Why or why not? 
• 
How informed do you think you are about lung transplant? 
• 
Do you still have questions or concerns about transplant? If so, what are 
they? 
If no prior research: 
• 
How informed do you think you are about lung transplant? 
• 
Where do you think you would start to look for information about lung 
transplant? 
• 
What information would you look for? 
• 
How might you benefit from learning about lung transplant? 
5. What is your understanding of the timing of lung transplant for advanced CF? 
• 
How did you come to understand the timing of transplant? 
• 
What do you understand about how CFTR modulators (for example, 
Trikafta) play a role in the timing of transplant? 
6. How ready do you feel to talk to your CF doctor about transplant? Why?  
• What types of questions or concerns do you have about lung transplant? 
7. Based on your conversations and/or research, how ready do you feel to make a 
decision about lung transplant? 
 
If decision has been made: 
• 
How did you come to make this decision? 
• 
What might influence your decision, making you more or less certain? 
 
If decision has not been made: 
• 
What could help you make a decision? 

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• 
When do you think you need to make this decision? 
• 
What might influence your decision? 
 
Week 2 - 30-minute session  
1. Can you tell me about how often you looked at the website over the past two weeks? 
2. Did the reminders impact your interest in visiting the website? What did you think 
about the frequency of the reminders? 
3. Was there anything that prevented you from using the website? If yes, can you walk 
me through them in more detail and discuss ways they could be addressed? 
4. Can you tell me about any technical issues you may have experienced with the 
website or devices? 
5. How satisfied are you with the amount of time you spent visiting the site over the past 
two weeks? Do you think there could be any value in returning at another time? What 
would you spend more time looking at? What might prompt you to return to the 
website again? 
6. Now can you tell me some of your general opinions about the website? Why was or 
wasn’t it engaging? 
7. Can you give me an example of some topics you enjoyed reading about or topics you 
might have preferred to avoid?  
8. Can you give me an example of information you might have found surprising? Why 
was it surprising to you? 
9. How did the content in the website make you feel? 
10. Do you think this website would be a good place to start your search for information 
about lung transplant for CF? Why or why not? Describe the questions about lung 
transplant that still remain after your use of this website.  
11. Why might you recommend this website to others or not?  
12. Do you think this would be a good website for your doctor to recommend? 
13. Imagine you have an appointment tomorrow with your CF doctor, how prepared do 
you feel to discuss lung transplant after using this website? Why? (consider asking: 
why not [lower on Likert scale]? why not [higher on Likert scale]?) 
14. How might you benefit from using the website with others (e.g. your doctor, friend, 
family)? Did you share any of the information on the website with others? If yes, 
what did you discuss? 
 
Week 4 - 60 minute session 
Goals of interview: 
• 
Feasibility of use 
• 
Preparedness for CF clinic visit 
• 
Psychological impact 
• 
Duration of RCT (4 weeks vs 3 months) 
1. Can you tell me about how often you looked at the website over the past two weeks? 
Was there anything that prevented you from using the website, technical issues or 
something else? If yes, can you walk me through them in more detail and discuss 
ways they could be addressed? 

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2. How satisfied are you with the amount of time you spent visiting the sites over the 
past four weeks? Do you think there could be any value in returning to either site at 
another time? What would you spend more time looking at? What might prompt you 
to return to the websites again?  
3. Can you compare your experience using the UNOS website to the Take on Transplant 
website?  
• 
Were you able to find information more easily in one website compared to 
the other? Can you give an example? What made it difficult to find the 
information you were looking for? 
• 
Did you find the information in the websites trustworthy? Why? Was there 
one website that was more or less reliable than the other? 
• 
Did one website help you feel more informed about lung transplant over 
the other? 
• 
Do you still have questions or concerns about transplant? If so, what are 
they and to which website would you choose to return to find answers? 
Why would you choose to return to one website over the other? 
• 
How often could you see yourself returning to the UNOS website? What 
about the Take on Transplant website? 
• 
Can you give me an example of something one website did better or worse 
than the other? 
4. How did the content in the websites make you feel? Did one website evoke more or 
less of an emotional reaction than the other? If so, can you elaborate or provide an 
example? 
• 
Did you find any of the content distressing or disturbing? 
• 
Did you find yourself thinking about the content when you were not 
looking at the website? For example, were you thinking about information 
from the website when you were trying to work, read, or fall asleep?  
• 
Did the website impact your mental health? If yes, how?  
5. Imagine you have an appointment tomorrow with your CF doctor, how prepared do 
you feel to discuss lung transplant after using the websites? How have they helped 
you feel more or less prepared to have a discussion with your CF doctor about lung 
transplant? As a reminder, two weeks ago you said you felt “XX” to have a 
discussion about lung transplant with your CF doctor? What are some things that 
changed or influenced this feeling? Was there one website that helped you to feel 
more prepared? Why/why not? 
 
Shifting focus to the ToT website: 
 
6. Can you tell me some of your general opinions on the three content areas (resource 
library, CF stories, and FAQs)?  
a. How would you improve your experience with [each content area]? 
b. Did you have any concerns with any of the content? 
7. What did you think about the lung transplant discussion urgency meter? 
8. Was the recommended content you received relevant to you? Why/why not? 

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9. Did the website suit your learning style? If not, why? What changes or additions 
could help? Would you prefer having the content in a different format (e.g. audio or 
video)? 
10. Can you tell me about the CF stories you read? Why did you choose to read those 
stories? How did you relate or not relate to them? How do you think the CF stories 
might be similar or different to conversations you would have with transplant 
recipients? 
11. How much of the content in ToT were you already familiar with (estimate a 
percentage)? Were you surprised by how much or how little you knew? Why/why 
not? 
12. Do you think ToT could be used by individuals with CF at various stages of their 
health?  
a. Why might you choose to use ToT when you are healthier?  
i. What information would you look for? 
ii. How could you benefit from using ToT?  
iii. What would be the ideal amount of time for you to spend with the 
website? 
b. What about when you are closer to needing a transplant?  
i. What information would you look for?   
ii. How could you benefit from using ToT? 
iii. What would be the ideal amount of time for you to spend with the 
website? 
13. In what ways could ToT help someone who is getting ready to talk to their doctor 
about lung transplant? How has it helped you feel more ready for these 
conversations? 
14. Can you give some examples of topics you want to discuss with your CF doctor? 
15. Would you have benefitted from using ToT with someone else like your doctor, a 
friend, or loved one? Did you get a chance to share anything from the site with 
anyone else? 
a. What would be the ideal amount of time for you to have with ToT prior to an 
appointment with your CF doctor? Would you want to access ToT again after 
you visit with your CF doctor? 
16. Why might you recommend this website to others or not? 
17. Do you think this would be a good website for your doctor to recommend? 
18. In what ways did ToT change what you know about lung transplant? Did it change 
any of your beliefs? 
19. What are some advantages of using ToT over to other resources about lung 
transplant? In what ways could ToT supplement other resources about lung 
transplant? 
20. Do you have any additional comments that you would like to share about your 
experience using ToT? 
 
[If research website not used] Barriers to using the tool: 
Please share the reasons you found it difficult to utilize the website. 

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1. Time: what prevented you from taking time to use the website? What competing 
priorities were you dealing with over these two weeks? 
2. Access: did you experience issues with technology at all or with devices (laptop, 
tablet, phone)? 
3. Interest: can you share your opinions about the website? Why wasn’t it engaging? 
Do you have criticisms? Did the email and/or text message reminders 
increase/change your interest in accessing the website? Were reminders too 
frequent, not frequent enough? 
4. Pertinence: why was the website not relevant for you? Do you think lung 
transplant is a treatment option you will ever need to consider? If not, why?  
5. Emotions: did you find the content upsetting or disturbing? In what ways? What 
particular parts of the content did you not want to read about or see? 
6. Considerations: can we talk about the reasons that prevented you from using the 
website?  I’d like to walk through them in more detail and discuss ways they 
might be addressed.  
7. Would you have benefitted from using this website with someone else like your 
doctor, a friend, or a loved one? 
 
 
 
 

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APPENDIX 2: Consent Form 
 
 
 
 

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