Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06030206
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2023-08-25
Brief Title:
Lung Transplant READY CF 2 A Multi-site RCT
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Preparation for Lung Transplant Discussions and Decisions Among People With Cystic Fibrosis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis CF In the United States more people with CF and low lung function die each year than undergo lung transplant More than half of people with CF who die without a lung transplant were never referred for consideration Patient preference not to undergo lung transplant may account for 25-40 of decisions to defer referral Rates of death without transplant are higher for people with CF who are members of marginalized communities including those with Black race Hispanic ethnicity or low socioeconomic status Increasing awareness of lung transplant among people with CF and promoting understanding of the risks and benefits of transplant can potentially reduce the number of people with CF who die without a lung transplant
The CF Foundation CFF lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant These guidelines recommend annual conversations with people with CF once their forced expiratory volume in one second FEV1 is 50 predicted Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist
Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions andor making decisions about lung transplant as a treatment option for advanced CF The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant Investigators also aim to understand whether there are unique factors that affect people with CF from communities with decreased access to transplant communities of concern
Study involvement will span 6 months and study activities will involve the following
Four Zoom research sessions 15-30 minutes each
Survey assessments
Access to a research website that contains educational resources about lung transplant
Audio recording of a routine CF clinic visit to determine if and how lung transplant is discussed between a participant and hishertheir CF doctor
The CF Foundation CFF lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant These guidelines recommend annual conversations with people with CF once their forced expiratory volume in one second FEV1 is 50 predicted Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist
Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions andor making decisions about lung transplant as a treatment option for advanced CF The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant Investigators also aim to understand whether there are unique factors that affect people with CF from communities with decreased access to transplant communities of concern
Study involvement will span 6 months and study activities will involve the following
Four Zoom research sessions 15-30 minutes each
Survey assessments
Access to a research website that contains educational resources about lung transplant
Audio recording of a routine CF clinic visit to determine if and how lung transplant is discussed between a participant and hishertheir CF doctor
Detailed Description:
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis CF In the United States more people with CF with forced expiratory volume in 1 second FEV1 less than 30 of predicted die each year than undergo lung transplant More than half of people with CF who die without lung transplant were never referred for consideration with patients of lower socioeconomic status Black race or Hispanic ethnicity disproportionately impacted by limited access to lung transplant Patient preference not to undergo lung transplant may account for 25-40 of decisions to defer referral The CF Foundation established lung transplant referral guidelines that recommend people with CF have annual conversations about lung transplant with their CF doctor once their FEV1 is less than 50 of predicted Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist By introducing an educational resource that can increase awareness of lung transplant among patients and promote understanding of the risks and benefits of lung transplant investigators aim to empower people with CF to take part in shared decision-making with their CF providers which could reduce the number of people with CF who die without lung transplant
Based on prior research investigators developed a novel lung transplant educational resource that addresses patient-identified knowledge gaps and provides personalized educational content to help people with CF prepare for lung transplant discussions and decisions The web-based educational resource couples real-life CF patient experiences of lung transplant in the form of personal narratives with up-to-date CF-specific and guideline-based medical information about lung transplant
The overall research objectives for this study are to test the efficacy of the investigator-designed educational resource to improve patient preparedness for shared decision making about lung transplant and knowledge about lung transplant and to evaluate the impact on mental health outcomes depression and anxiety The investigator-designed website will be compared to an attention control website to better understand how people with CF use and rank different educational resources utility The central hypothesis is that use of the new investigator-designed website that incorporates disease severity data FEV1 predicted supplemental oxygen use exacerbations to identify relevant personal narratives and guideline-based educational content will increase a patients preparedness to engage in discussions about lung transplant beyond the standard information presented on the attention control website
The study will be a randomized controlled trial Participants will be randomly assigned 11 to one of two educational resources described above stratified by FEV1 category FEV1 30-50 or FEV1 30 of predicted CF Center and whether they are members of the communities of concern The communities of concern include people with Medicaid insurance high school education or less Hispanic ethnicity or BlackAsianOther race not White race Baseline surveys will evaluate knowledge about lung transplant a Likert scale rating of preparedness for lung transplant discussions decisional conflict about lung transplant and mental health For three months participants will have access to one of two educational resources via a login to a secure research website At 2 weeks there will be a study visit that includes repeated surveys from baseline and the Preparedness for Shared Decision Making PrepDM Scale At 2 to 3 months after randomization participants will have a routine CF clinic visit which may be audio-recorded for evaluation of lung transplant discussion At 3 months after randomization there will be a study visit that includes repeated surveys from baseline and the PrepDM Scale After the 3-month study visit participants will have access to both educational resources via individual login to the secure research website At 6-months there will be a study visit to repeat the surveys Throughout the 6-months and for a long-term follow up period of 4 years web analytics will be captured at the individual level to determine usage patterns for both educational resources
Based on prior research investigators developed a novel lung transplant educational resource that addresses patient-identified knowledge gaps and provides personalized educational content to help people with CF prepare for lung transplant discussions and decisions The web-based educational resource couples real-life CF patient experiences of lung transplant in the form of personal narratives with up-to-date CF-specific and guideline-based medical information about lung transplant
The overall research objectives for this study are to test the efficacy of the investigator-designed educational resource to improve patient preparedness for shared decision making about lung transplant and knowledge about lung transplant and to evaluate the impact on mental health outcomes depression and anxiety The investigator-designed website will be compared to an attention control website to better understand how people with CF use and rank different educational resources utility The central hypothesis is that use of the new investigator-designed website that incorporates disease severity data FEV1 predicted supplemental oxygen use exacerbations to identify relevant personal narratives and guideline-based educational content will increase a patients preparedness to engage in discussions about lung transplant beyond the standard information presented on the attention control website
The study will be a randomized controlled trial Participants will be randomly assigned 11 to one of two educational resources described above stratified by FEV1 category FEV1 30-50 or FEV1 30 of predicted CF Center and whether they are members of the communities of concern The communities of concern include people with Medicaid insurance high school education or less Hispanic ethnicity or BlackAsianOther race not White race Baseline surveys will evaluate knowledge about lung transplant a Likert scale rating of preparedness for lung transplant discussions decisional conflict about lung transplant and mental health For three months participants will have access to one of two educational resources via a login to a secure research website At 2 weeks there will be a study visit that includes repeated surveys from baseline and the Preparedness for Shared Decision Making PrepDM Scale At 2 to 3 months after randomization participants will have a routine CF clinic visit which may be audio-recorded for evaluation of lung transplant discussion At 3 months after randomization there will be a study visit that includes repeated surveys from baseline and the PrepDM Scale After the 3-month study visit participants will have access to both educational resources via individual login to the secure research website At 6-months there will be a study visit to repeat the surveys Throughout the 6-months and for a long-term follow up period of 4 years web analytics will be captured at the individual level to determine usage patterns for both educational resources
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01NR020470-01A1 | NIH | None | httpsreporternihgovquickSearch1R01NR020470-01A1 |