Lung Transplant READY Pilot Study

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.