Refer2Quit Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Smoking; Smoking Cessation; Second Hand Tobacco Smoke
• Interventions: Other: Refer2Quit

• Registration Number: NCT06582693
• Lead Sponsor: Children's Hospital of Philadelphia

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 Children's Hospital of Philadelphia's (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. We will deploy a remote recruitment strategy (via phone and/or 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, and/or 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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study Start: 2024-09-01
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Refer2Quit	Adult intervention arm participants will receive motivational counseling provided by the study staff member enrolling them. The study team member will offer 4 evidence-based treatment options (varenicline, NRT, quitline, and/or smokefreeTXT), emphasizing that the combination is often more effective than one treatment alone, and that they could start treatment even if they are not ready to quit.

Primary Outcome Measures

Name	Time	Method
The proportion of adult participants who engage in any evidence-based tobacco use treatments	Baseline, 1 and 6 months	The proportion of adult participants who engage in any evidence-based tobacco use treatments, between the intervention and control arms, by adult participant self-report.
Combustible tobacco quit rate at 1 and 6 months	1 and 6 months	The quit rate, compared between the intervention and control arms, will be assessed by a self-reported 7-day point prevalence smoking abstinence, collected via follow-up survey, and confirmed via breath carbon monoxide (CO) \<5ppm at the time-point

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States