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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03HL158728-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Cystic Fibrosis Foundation | OTHER |
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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:
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more CF patients with forced expiratory volume in 1 second (FEV1) less than 30% of predicted die each year than undergo lung transplant. More than half of people with CF who die without lung transplant were never referred for consideration, with patients of lower socioeconomic status disproportionately impacted by limited access to lung transplant. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. The CF Foundation established lung transplant referral guidelines that recommend individuals with CF have annual conversations about lung transplant with their CF doctor once their FEV1 is less than 50% of predicted. Considering lung transplant as a treatment option ahead of when it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. By introducing an educational resource that can increase awareness of lung transplant among patients, and promote understanding of the risks and benefits of lung transplant, investigators aim to empower people with CF to take part in shared decision-making with their CF providers which could reduce the number of people with CF who die without lung transplant.
Based on prior research, investigators have developed a novel lung transplant decision support tool that addresses patient-identified knowledge gaps and provides personalized educational content to help people with CF prepare for lung transplant discussions and decisions. The decision support tool couples real-life CF patient experiences of lung transplant in the form of personal narratives with up-to-date, CF-specific, and guideline-based medical information about lung transplant.
The overall research objectives for this pilot study are to test the efficacy of the decision support tool to improve patient preparedness for shared decision making about lung transplant and knowledge about lung transplant, and to evaluate the impact on mental health outcomes (depression and anxiety). The new website will be compared against an attention control website (UNOS.org) to better understand how people with CF use and rank different educational resources' utility. The central hypothesis is that use of the new decision support tool that incorporates disease severity data (FEV1 % predicted, supplemental oxygen use, exacerbations) to identify relevant personal narratives and guideline-based educational content will increase a patient's preparedness to engage in discussions about lung transplant beyond the standard information presented on UNOS.org.
The pilot study will be a randomized controlled trial. Participants will be randomized 1:1 to one of two educational resources, described above, stratified by FEV1 category (FEV1 30-50% or FEV1 <30% of predicted). Baseline surveys will evaluate knowledge about lung transplant, a Likert scale rating of preparedness for lung transplant discussions, decisional conflict about lung transplant, and mental health. Baseline interviews will address perspectives on lung transplant as a treatment option for CF and the role of newer CF therapies in the decision making process about lung transplant. For two weeks, participants will have access to one of two educational resources via a login to a secure research website. At 2 weeks, there will be a study visit that includes repeated surveys from baseline and the Preparedness for Shared Decision Making (PrepDM) Scale, along with a second brief interview. After the 2-week study visit, participants will have access to both educational resources via individual login to the secure research website. At 4 weeks, there will be a study visit to repeat the surveys and interview. Throughout the 4 weeks, web analytics will be captured at the individual level to determine usage patterns for both educational resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Access to an investigator-designed web-based educational resource with information about lung transplant for two weeks. |
|
| Control | Active Comparator | Access to a publicly available web-based educational resource with information about transplant for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigator-designed lung transplant education resource (Research Intervention) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measured at 2-week study visit |
| 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. | Measured at 2-week study visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Ramos, MD, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30926322 | Background | Ramos KJ, Smith PJ, McKone EF, Pilewski JM, Lucy A, Hempstead SE, Tallarico E, Faro A, Rosenbluth DB, Gray AL, Dunitz JM; CF Lung Transplant Referral Guidelines Committee. Lung transplant referral for individuals with cystic fibrosis: Cystic Fibrosis Foundation consensus guidelines. J Cyst Fibros. 2019 May;18(3):321-333. doi: 10.1016/j.jcf.2019.03.002. Epub 2019 Mar 27. | |
| 34419372 | Background | Leard LE, Holm AM, Valapour M, Glanville AR, Attawar S, Aversa M, Campos SV, Christon LM, Cypel M, Dellgren G, Hartwig MG, Kapnadak SG, Kolaitis NA, Kotloff RM, Patterson CM, Shlobin OA, Smith PJ, Sole A, Solomon M, Weill D, Wijsenbeek MS, Willemse BWM, Arcasoy SM, Ramos KJ. Consensus document for the selection of lung transplant candidates: An update from the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2021 Nov;40(11):1349-1379. doi: 10.1016/j.healun.2021.07.005. Epub 2021 Jul 24. |
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De-identified individual participant data (IPD) may be shared with other researchers for secondary analyses with the approval of the appropriate Human Subjects Division(s) and the study's principal investigator (PI).
Data will become available after publication of the results of the primary analyses of the study. The data will be available for up to 3 years after the end of the study.
Qualified researchers with appropriate clinical research training and/or mentorship will be allowed to have access to IPD after approval is obtained from Human Subjects Division(s) and the study PI.
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A total of 52 participants consented. Of these, 2 were lost to follow up and 50 were randomized to study arms, 25 per arm.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Consented, Not Randomized | Participants who consented but were not randomized |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | Measured at 2-week study visit |
|
Adverse event data were collected during Zoom study visits (baseline, 2 weeks, 4 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Investigator-designed lung transplant education resource (Research Intervention) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Possible suicidality endorsed on PHQ-9 | Psychiatric disorders | Systematic Assessment | For the purposes of this study, participant report of possible suicidality on the PHQ-9 (positive response to question #9) is an immediately reportable AE, even if it is not an SAE. PHQ-9 is only administered during Zoom study visits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen J. Ramos | University of Washington | 2065430393 | ramoskj@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 29, 2023 | Oct 30, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
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|
| Publicly available transplant education resource (Attention Control) | Behavioral | 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. |
|
| Measured at 2-week study visit |
| 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]. | Baseline to 2-week study visit |
| 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. | Measured at 2-week study visit |
| 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. | Measured at 2-week study visit |
| 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. | Measured at 2-week study visit |
| 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. | Measured at 2-week study visit |
| 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. | Measured at 2-week study visit |
| Measured at 4-week study visit |
| 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. | Measured at Baseline, 2-week study visit, 4-week study visit |
| 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. | Measured at Baseline, 2-week study visit, 4-week study visit |
| 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. | Measured at baseline, 2-week and 4-week study visits |
| 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. | Baseline to 2-week study visit |
| 31003953 | Background | Ramos KJ, Hobler MR, Engelberg RA, Curtis JR, Zander MI, Howard SS, Goss CH, Aitken ML. Addressing lung transplant with adults with cystic fibrosis: A qualitative analysis of patients' perspectives and experiences. J Cyst Fibros. 2019 May;18(3):416-419. doi: 10.1016/j.jcf.2019.04.007. Epub 2019 Apr 17. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Community of Concern (Yes/No) | Participants were considered to belong to a Community of Concern if they met one or more of the following criteria: Medicaid insurance, High school education or less, non-White race, Hispanic ethnicity. | Count of Participants | Participants |
|
| Taking CFTR modulator | Count of Participants | Participants |
|
| Current FEV1 %predicted | Count of Participants | Participants |
|
| 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. |
| OG002 | Consented, Not Randomized | Consented but lost to follow up prior to baseline study visit |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Measured at 2-week study visit |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Measured at 2-week study visit |
|
|
|
|
| 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]. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 2-week study visit |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Measured at 2-week study visit |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Measured at 2-week study visit |
|
|
|
|
| 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. | Posted | Number | proportion of participants | Measured at 2-week study visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Measured at 2-week study visit |
|
|
|
|
| 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. | Posted | Number | proportion of participants | Measured at 2-week study visit |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Measured at 4-week study visit |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Measured at Baseline, 2-week study visit, 4-week study visit |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Measured at Baseline, 2-week study visit, 4-week study visit |
|
|
|
|
| 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. | Posted | Number | proportion of participants | Measured at baseline, 2-week and 4-week study visits |
|
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| 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. | Posted | Median | Inter-Quartile Range | minutes | Baseline to 2-week study visit |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | Control | Publicly available transplant education resource (Attention Control) | 0 | 25 | 0 | 25 | 1 | 25 |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| 4 weeks |
|
Outcome = change in Likert preparedness to discuss transplant from baseline to 2-week study visit |
| Regression, Linear |
| 0.53 |
| Mean Difference (Net) |
| 0.04 |
| 2-Sided |
| 95 |
| -0.08 |
| 0.16 |
Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks). |
| Superiority |
| Outcome = change in Decisional Conflict Scale from baseline to 2-week study visit | Regression, Linear | 0.04 | Mean Difference (Net) | -4.3 | 2-Sided | 95 | -8.4 | -0.3 | Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks). | Superiority |
| Regression, Linear | 0.74 | Outcome = mean PrepDM Scale at 2-weeks | Mean Difference (Final Values) | 0.7 | 2-Sided | 95 | -3.6 | 5.0 | Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks). | Superiority |