Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638554
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Integrating Telehealth to Advance Lung Cancer Screening
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrating Telehealth to Advance Lung Cancer Screening
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITALCS
Brief Summary:
The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making SDM for lung cancer screening LCS It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex The main questions it aims to answer are
1 Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS
2 Is the effectiveness of these telehealth strategies similar by race and sex
The study uses a Sequential Multiple Assignment Randomized Trial SMART design and includes two stages of interventions The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1 telehealth SDM visit or 2 telehealth or in-person SDM visit Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination
1 Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS
2 Is the effectiveness of these telehealth strategies similar by race and sex
The study uses a Sequential Multiple Assignment Randomized Trial SMART design and includes two stages of interventions The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1 telehealth SDM visit or 2 telehealth or in-person SDM visit Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination
Detailed Description:
Annual lung cancer screening using low-dose computed tomography LDCT is associated with decreased lung cancer mortality but also with harms As such it is recommended and required for reimbursement that patients complete an shared decision-making visit SDM prior to screening to discuss potential risks and benefits in the context of patient values Despite guidelines recommending screening and national insurance coverage of LDCT uptake of SDM visits and subsequent LDCT is remarkably low We aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on SDM visits and subsequent LDCT in a pragmatic trial using a Sequential Multiple Assignment Randomized Trial SMART design The specific first stage strategies to be tested are a Active Choice Outreach invitation to schedule a telehealth or in-person SDM visit vs b Telehealth Only Outreach invitation to schedule a telehealth SDM visit The specific second stage strategies delivered only if participants do not respond to first stage interventions are a text message reminders encouraging SDM visit completion low-touch alone or b in combination with phone-based digital care coordination high-touch We will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None