Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582693
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Refer2Quit Evaluating a Proactive Tailored Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Refer2Quit Evaluating a Proactive Tailored Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The goal of this clinical trial is to compare the reach and effectiveness of the Refer2Quit intervention for increasing tobacco use treatment and quit rates among household members who smoke versus a treatment as usual group This clinical trial also aims to study household member and pediatric patient characteristics that are associated with reach and effectiveness of Refer2Quit
Detailed Description:
This study aims to evaluate a proactive and population health-based approach that leverages a clinical decision support CDS system embedded in the electronic health record EHR to identify household members who smoke but did not complete the smoking survey at the visit and remotely engage them in tobacco use treatment
Participants will be recruited through up to 32 outpatient primary care practice from the Childrens Hospital of Philadelphias CHOP Pediatric Research Consortium PeRC Potential participants will be identified from the cohort of referrals for tobacco cessation treatment Randomization of adult participants into either the intervention or control group will occur after the participants have consented to partake in the study and completed enrollment The investigators will deploy a remote recruitment strategy via phone andor text to outreach to eligible adult participants to maximize recruitment efforts
After the initial referral of the household member who smokes a study team member will reach out to them explain the reason they are being contacted and confirm their smoking status and age All participants will complete the enrollment step with data collection including adult participant demographics nicotine dependence and quitting motivation
Only the intervention arm will receive the opportunity to be automatically connected by the study team to four evidence-based tobacco treatment options varenicline nicotine replacement therapy NRT quitline andor smokefreeTXT Adult intervention arm participants will also receive brief motivational counseling by the study team
Adult control arm participants will receive treatment as usual which consistent of a handout of evidence tobacco treatment resources which the adult participant must connect with on their own
Enrolled adult participants in both the intervention and control arms will be followed-up via surveys at approximately 1 and 6-month time intervals Adult participants who self-report 7-day abstinence at the 1 and 6-month surveys will be asked to confirm smoking cessation through carbon monoxide testing
Participants will be recruited through up to 32 outpatient primary care practice from the Childrens Hospital of Philadelphias CHOP Pediatric Research Consortium PeRC Potential participants will be identified from the cohort of referrals for tobacco cessation treatment Randomization of adult participants into either the intervention or control group will occur after the participants have consented to partake in the study and completed enrollment The investigators will deploy a remote recruitment strategy via phone andor text to outreach to eligible adult participants to maximize recruitment efforts
After the initial referral of the household member who smokes a study team member will reach out to them explain the reason they are being contacted and confirm their smoking status and age All participants will complete the enrollment step with data collection including adult participant demographics nicotine dependence and quitting motivation
Only the intervention arm will receive the opportunity to be automatically connected by the study team to four evidence-based tobacco treatment options varenicline nicotine replacement therapy NRT quitline andor smokefreeTXT Adult intervention arm participants will also receive brief motivational counseling by the study team
Adult control arm participants will receive treatment as usual which consistent of a handout of evidence tobacco treatment resources which the adult participant must connect with on their own
Enrolled adult participants in both the intervention and control arms will be followed-up via surveys at approximately 1 and 6-month time intervals Adult participants who self-report 7-day abstinence at the 1 and 6-month surveys will be asked to confirm smoking cessation through carbon monoxide testing
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