Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Lung Transplantation, Lung Disease, Decision Support Tool
Brief summary
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant. The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with CF patients once their forced expiratory volume in one second (FEV1) is \<50% predicted. Considering lung transplant as a treatment option ahead of when it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant. Study involvement will span 4 weeks and study procedures will involve the following: * Three Zoom interview sessions (30-60 minutes each) * Survey assessments * Access to a research website that contains educational resources about lung transplant (goal of 4 hours of use over the 4 week study period)
Detailed description
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more CF patients with forced expiratory volume in 1 second (FEV1) less than 30% of predicted die each year than undergo lung transplant. More than half of people with CF who die without lung transplant were never referred for consideration, with patients of lower socioeconomic status disproportionately impacted by limited access to lung transplant. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. The CF Foundation established lung transplant referral guidelines that recommend individuals with CF have annual conversations about lung transplant with their CF doctor once their FEV1 is less than 50% of predicted. Considering lung transplant as a treatment option ahead of when it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. By introducing an educational resource that can increase awareness of lung transplant among patients, and promote understanding of the risks and benefits of lung transplant, investigators aim to empower people with CF to take part in shared decision-making with their CF providers which could reduce the number of people with CF who die without lung transplant. Based on prior research, investigators have developed a novel lung transplant decision support tool that addresses patient-identified knowledge gaps and provides personalized educational content to help people with CF prepare for lung transplant discussions and decisions. The decision support tool couples real-life CF patient experiences of lung transplant in the form of personal narratives with up-to-date, CF-specific, and guideline-based medical information about lung transplant. The overall research objectives for this pilot study are to test the efficacy of the decision support tool to improve patient preparedness for shared decision making about lung transplant and knowledge about lung transplant, and to evaluate the impact on mental health outcomes (depression and anxiety). The new website will be compared against an attention control website (UNOS.org) to better understand how people with CF use and rank different educational resources' utility. The central hypothesis is that use of the new decision support tool that incorporates disease severity data (FEV1 % predicted, supplemental oxygen use, exacerbations) to identify relevant personal narratives and guideline-based educational content will increase a patient's preparedness to engage in discussions about lung transplant beyond the standard information presented on UNOS.org. The pilot study will be a randomized controlled trial. Participants will be randomized 1:1 to one of two educational resources, described above, stratified by FEV1 category (FEV1 30-50% or FEV1 \<30% of predicted). Baseline surveys will evaluate knowledge about lung transplant, a Likert scale rating of preparedness for lung transplant discussions, decisional conflict about lung transplant, and mental health. Baseline interviews will address perspectives on lung transplant as a treatment option for CF and the role of newer CF therapies in the decision making process about lung transplant. For two weeks, participants will have access to one of two educational resources via a login to a secure research website. At 2 weeks, there will be a study visit that includes repeated surveys from baseline and the Preparedness for Shared Decision Making (PrepDM) Scale, along with a second brief interview. After the 2-week study visit, participants will have access to both educational resources via individual login to the secure research website. At 4 weeks, there will be a study visit to repeat the surveys and interview. Throughout the 4 weeks, web analytics will be captured at the individual level to determine usage patterns for both educational resources.
Interventions
Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources.
BEHAVIORALPublicly available transplant education resource (Attention Control)
Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Cystic Fibrosis Foundation
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of cystic fibrosis * FEV1 less than or equal to 50% predicted (unless referred per MD recommendation)
Exclusion criteria
* Patients unable to provide informed consent * Patients who are lung transplant recipients * Unable to read or understand English to complete surveys or access the websites (currently only available in English)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Participants Completing 2-week Study Visit | Measured at 2-week study visit | The co-primary endpoint is feasibility, which will be defined as successful if 90% of enrolled participants complete the 2-week study visit (regardless of study arm). |
| Preparedness for Shared Decision Making (PrepDM) Scale | Measured at 2-week study visit | The co-primary endpoint is an intention-to-treat assessment of the difference in mean Preparedness for Shared Decision Making (PrepDM) Scale in the intervention versus control arms of the study at the 2-week study visit. Scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | Baseline to 2-week study visit | Decisional Conflict Scale change will be measured from the baseline study visit to the 2-week study visit. The intention-to-treat analysis will compare mean change in the Decisional Conflict Scale between the intervention and control arms of the study. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]. |
| Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey) | Measured at 2-week study visit | Difference in mean confidence-weighted true false (CTF) knowledge score will be measured in the intervention versus control arms of the study. CTF scoring adds points for certainty in correct responses and deducts points for certainty in incorrect responses. Participants receive +2 points when sure about a correct response, +1 if unsure about a correct response, -1 if unsure about an incorrect response and -2 if sure about an incorrect response. For a 14-item knowledge test, the maximum score is +28 and the minimum score is -28, with higher scores indicating more knowledge about lung transplant. |
| Likert-scale Rating of Preparedness to Discuss Lung Transplant (0-4) | Measured at 2-week study visit | Likert rating of preparedness will be measured at the 2-week study visit (0=Don't know, 1= Not at all prepared, 2 = A little prepared, 3 = Moderately prepared, 4 = Very prepared). The intention-to-treat analysis will compare mean Likert-scale rating between the intervention and control arms of the study. |
| Patient Health Questionnaire (PHQ-9) | Measured at 2-week study visit | PHQ-9 is a scale that measures symptoms of depression in the prior 2 weeks on a 0-27 scale, with higher scores indicating worsening depression and a score of 10 or higher consistent with a diagnosis of depression. Investigators will assess the difference in mean PHQ-9 score in the intervention versus control arms of the study at the 2-week study visit. |
| Generalized Anxiety Disorder 7-item (GAD-7) Scale | Measured at 2-week study visit | GAD-7 is a scale that measures symptoms of anxiety in the prior 2 weeks on a 0-21 scale, with higher scores indicating worsening anxiety and a score of 10 or higher consistent with a diagnosis of generalized anxiety disorder. Investigators will assess the difference in mean GAD-7 score in the intervention versus control arms of the study at the 2-week study visit. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 4-week Assessment for Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey) | Measured at Baseline, 2-week study visit, 4-week study visit | Change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey with minimum possible score -28 and maximum possible score 28; higher scores indicate more knowledge about lung transplant) will be assessed from immediately prior to intervention exposure to the end of exposure time. For participants in the intervention arm, this represents change from baseline to 4-weeks. For participants in the Attention Control arm, this represents change from 2-week to 4-week study visits. The statistical analysis will compare mean change in the knowledge score from baseline to 4 weeks between study arms. This compares the effect of 4-week exposure to Take on Transplant \[intervention arm\] vs. 2-week exposure \[control arm\] on improvement in knowledge scores. |
| 4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant | Measured at baseline, 2-week and 4-week study visits | Evaluate the proportion Very prepared at baseline, 2 weeks and 4 weeks in the intervention and control arms. Compare proportions across study arms at each time point. |
| Time Spent Using the Research Website | Baseline to 2-week study visit | Median time spent using the research website from baseline to 2 weeks will be compared across study arms. Further, time spent using the investigator-designed website will be assessed as a predictor of: 1. change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visit, 2. change in Likert preparedness from baseline to 2-week study visit, 3. change in Decisional Conflict Scale from baseline to 2-week study visit, and 4. mean PrepDM Scale at 2-weeks. |
| 4-week Assessment for Decisional Conflict Scale | Measured at Baseline, 2-week study visit, 4-week study visit | Change in Decisional Conflict Scale (scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]) will be assessed from immediately prior to intervention exposure to the end of exposure time. For participants in the intervention arm, this represents change from baseline to 4-weeks. For participants in the Attention Control arm, this represents change from 2-week to 4-week study visits. The statistical analysis will compare mean change in Decisional Conflict Scale from baseline to 4 weeks between study arms. This compares the effect of 4-week exposure to Take on Transplant \[intervention arm\] vs. 2-week exposure \[control arm\] on improvement in knowledge scores. |
| 4-week Assessment of Preparedness for Shared Decision Making (PrepDM) Scale | Measured at 4-week study visit | The PrepDM Scale will be measured for all participants with respect to the investigator-designed educational resource (research intervention) and mean score will be compared for participants in the intervention (4 weeks of exposure) versus control arms (2 weeks of exposure). PrepDM scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making. |
Countries
United States
Participant flow
Recruitment details
A screening survey was advertised at 15 CF Centers in the United States who agreed to approach their adult CF patients with an FEV1 \<50% predicted to share information about our study. Survey respondents could 'opt in' to being contacted about additional research opportunities related to lung transplant. We also approached CF patients at the University of Washington Adult CF Center who had an FEV1 \<50% predicted. Recruitment occurred from December 2021 to November 2022.
Pre-assignment details
A total of 52 participants consented. Of these, 2 were lost to follow up and 50 were randomized to study arms, 25 per arm.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks.
Investigator-designed lung transplant education resource (Research Intervention): Participants will access the investigator-designed educational resource via their login to a secure website. After two weeks, participants will gain access to the publicly available website (attention control) and will have an additional two weeks of access to both of these resources. | 25 |
| Control Access to a publicly available web-based educational resource with information about transplant for two weeks.
Publicly available transplant education resource (Attention Control): Participants will access the publicly available education resource via their login to a secure website. After two weeks, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional two weeks of access to both of these resources. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Continuous | 40 years | 35 years | 37 years |
| Community of Concern (Yes/No) | 13 Participants | 18 Participants | 31 Participants |
| Current FEV1 %predicted <30% | 4 Participants | 4 Participants | 8 Participants |
| Current FEV1 %predicted 30-40% | 8 Participants | 14 Participants | 22 Participants |
| Current FEV1 %predicted 41-50% | 13 Participants | 7 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 23 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 25 Participants | 23 Participants | 48 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 9 Participants | 15 Participants | 24 Participants |
| Sex: Female, Male Male | 16 Participants | 10 Participants | 26 Participants |
| Taking CFTR modulator | 24 Participants | 24 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 2 / 25 | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Feasibility of Participants Completing 2-week Study Visit
The co-primary endpoint is feasibility, which will be defined as successful if 90% of enrolled participants complete the 2-week study visit (regardless of study arm).
Time frame: Measured at 2-week study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Feasibility of Participants Completing 2-week Study Visit | 25 Participants |
| Control | Feasibility of Participants Completing 2-week Study Visit | 25 Participants |
| Consented, Not Randomized | Feasibility of Participants Completing 2-week Study Visit | 0 Participants |
Primary
Preparedness for Shared Decision Making (PrepDM) Scale
The co-primary endpoint is an intention-to-treat assessment of the difference in mean Preparedness for Shared Decision Making (PrepDM) Scale in the intervention versus control arms of the study at the 2-week study visit. Scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.
Time frame: Measured at 2-week study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Preparedness for Shared Decision Making (PrepDM) Scale | 71 score on a scale | Standard Deviation 16 |
| Control | Preparedness for Shared Decision Making (PrepDM) Scale | 57 score on a scale | Standard Deviation 23 |
p-value: 0.0295% CI: [3, 25]Regression, Linear
Secondary
Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey)
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.
Time frame: Measured at 2-week study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey) | 11.6 score on a scale | Standard Deviation 6 |
| Control | Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey) | 8.8 score on a scale | Standard Deviation 7.4 |
p-value: 0.1595% CI: [-1, 6.6]Regression, Linear
Secondary
Decisional Conflict Scale
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 \[extremely high decisional conflict\].
Time frame: Baseline to 2-week study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Decisional Conflict Scale | -12 score on a scale | Standard Deviation 17 |
| Control | Decisional Conflict Scale | -11 score on a scale | Standard Deviation 17 |
p-value: 0.8195% CI: [-10.9, 8.5]Regression, Linear
Secondary
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. 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.
Time frame: Measured at 2-week study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 4.6 score on a scale | Standard Deviation 4.1 |
| Control | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 4.3 score on a scale | Standard Deviation 4.3 |
p-value: 0.8295% CI: [-2.1, 2.7]Regression, Linear
Secondary
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. Investigators will determine the proportion with new GAD-7 score greater than or equal to 10 in each arm.
Time frame: Measured at 2-week study visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 0.08 proportion of participants |
| Control | Generalized Anxiety Disorder 7-item (GAD-7) Scale | 0.16 proportion of participants |
Secondary
Likert-scale Rating of Preparedness to Discuss Lung Transplant (0-4)
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.
Time frame: Measured at 2-week study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Likert-scale Rating of Preparedness to Discuss Lung Transplant (0-4) | 3.4 units on a scale | Standard Deviation 0.7 |
| Control | Likert-scale Rating of Preparedness to Discuss Lung Transplant (0-4) | 3.1 units on a scale | Standard Deviation 0.9 |
p-value: 0.1595% CI: [-0.1, 0.8]Regression, Linear
Secondary
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. Investigators will determine the proportion with new PHQ-9 score greater than or equal to 10 in each arm.
Time frame: Measured at 2-week study visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Patient Health Questionnaire (PHQ-9) | 0.16 proportion of participants |
| Control | Patient Health Questionnaire (PHQ-9) | 0.12 proportion of participants |
Secondary
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. 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.
Time frame: Measured at 2-week study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Patient Health Questionnaire (PHQ-9) | 5.6 score on a scale | Standard Deviation 5.2 |
| Control | Patient Health Questionnaire (PHQ-9) | 4.8 score on a scale | Standard Deviation 4.8 |
p-value: 0.5495% CI: [-2, 3.7]Regression, Linear
Other Pre-specified
4-week Assessment for Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey)
Change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey with minimum possible score -28 and maximum possible score 28; higher scores indicate more knowledge about lung transplant) will be assessed from immediately prior to intervention exposure to the end of exposure time. For participants in the intervention arm, this represents change from baseline to 4-weeks. For participants in the Attention Control arm, this represents change from 2-week to 4-week study visits. The statistical analysis will compare mean change in the knowledge score from baseline to 4 weeks between study arms. This compares the effect of 4-week exposure to Take on Transplant \[intervention arm\] vs. 2-week exposure \[control arm\] on improvement in knowledge scores.
Time frame: Measured at Baseline, 2-week study visit, 4-week study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 4-week Assessment for Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey) | 4.4 score on a scale | Standard Deviation 4.2 |
| Control | 4-week Assessment for Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey) | 1.2 score on a scale | Standard Deviation 4.2 |
p-value: 0.3195% CI: [-1.3, 3.9]Regression, Linear
Other Pre-specified
4-week Assessment for Decisional Conflict Scale
Change in Decisional Conflict Scale (scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]) will be assessed from immediately prior to intervention exposure to the end of exposure time. For participants in the intervention arm, this represents change from baseline to 4-weeks. For participants in the Attention Control arm, this represents change from 2-week to 4-week study visits. The statistical analysis will compare mean change in Decisional Conflict Scale from baseline to 4 weeks between study arms. This compares the effect of 4-week exposure to Take on Transplant \[intervention arm\] vs. 2-week exposure \[control arm\] on improvement in knowledge scores.
Time frame: Measured at Baseline, 2-week study visit, 4-week study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 4-week Assessment for Decisional Conflict Scale | -16.4 score on a scale | Standard Deviation 16.4 |
| Control | 4-week Assessment for Decisional Conflict Scale | -10.4 score on a scale | Standard Deviation 21.4 |
p-value: 0.4295% CI: [-7.4, 17.4]Regression, Linear
Other Pre-specified
4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant
Evaluate the proportion Very prepared at baseline, 2 weeks and 4 weeks in the intervention and control arms. Compare proportions across study arms at each time point.
Time frame: Measured at baseline, 2-week and 4-week study visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | 4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant | 2 weeks | 0.52 proportion of participants |
| Intervention | 4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant | Baseline | 0.52 proportion of participants |
| Intervention | 4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant | 4 weeks | 0.76 proportion of participants |
| Control | 4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant | Baseline | 0.40 proportion of participants |
| Control | 4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant | 2 weeks | 0.40 proportion of participants |
| Control | 4-week Assessment for Likert-scale Rating of Preparedness to Discuss Lung Transplant | 4 weeks | 0.60 proportion of participants |
p-value: 0.39Chi-squared
Other Pre-specified
4-week Assessment of Preparedness for Shared Decision Making (PrepDM) Scale
The PrepDM Scale will be measured for all participants with respect to the investigator-designed educational resource (research intervention) and mean score will be compared for participants in the intervention (4 weeks of exposure) versus control arms (2 weeks of exposure). PrepDM scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.
Time frame: Measured at 4-week study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | 4-week Assessment of Preparedness for Shared Decision Making (PrepDM) Scale | 72 score on a scale | Standard Deviation 22 |
| Control | 4-week Assessment of Preparedness for Shared Decision Making (PrepDM) Scale | 77 score on a scale | Standard Deviation 17 |
p-value: 0.4495% CI: [-15, 7]Regression, Linear
Other Pre-specified
Time Spent Using the Research Website
Median time spent using the research website from baseline to 2 weeks will be compared across study arms. Further, time spent using the investigator-designed website will be assessed as a predictor of: 1. change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visit, 2. change in Likert preparedness from baseline to 2-week study visit, 3. change in Decisional Conflict Scale from baseline to 2-week study visit, and 4. mean PrepDM Scale at 2-weeks.
Time frame: Baseline to 2-week study visit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Time Spent Using the Research Website | 133 minutes |
| Control | Time Spent Using the Research Website | 142 minutes |
Comparison: Outcome = change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visitp-value: 0.9195% CI: [-0.84, 0.94]Regression, Linear
Comparison: Outcome = change in Likert preparedness to discuss transplant from baseline to 2-week study visitp-value: 0.5395% CI: [-0.08, 0.16]Regression, Linear
Comparison: Outcome = change in Decisional Conflict Scale from baseline to 2-week study visitp-value: 0.0495% CI: [-8.4, -0.3]Regression, Linear
p-value: 0.7495% CI: [-3.6, 5]Regression, Linear