Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Second Hand Tobacco Smoke; Smoking; Smoking Cessation

Treatments: Other: Refer2Quit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06582693

23-021075

1R37CA282153-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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. The investigators 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.

Enrollment: 3,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Adult Intervention Subject Inclusion Criteria

• Males or females ages ≥18 years in age
• Self-identify as a current combustible tobacco user
• Have a valid cell phone number

Child Intervention Subject Inclusion Criteria

• Must be a CHOP patient

Adult Intervention Subject Exclusion Criteria

• <18 years in age.
• Indicates no combustible tobacco smoking

Child Intervention Subject Exclusion Criteria

• Not a CHOP patient

Adult Control Subject Inclusion Criteria

• Males or females ages ≥18 years in age
• Self-identify as a current combustible tobacco user
• Have a valid cell phone number

Child Control Subject Inclusion Criteria

• Must be a CHOP patient

Adult Control Subject Exclusion Criteria

• <18 years in age.
• Indicates no combustible tobacco smoking

Child Control Subject Exclusion Criteria

• Not a CHOP patient

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,200 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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.

Treatment:

Other: Refer2Quit

Control Arm

No Intervention group

Description:

Adult control arm participants will receive a handout listing tobacco treatment options that they can connect to on their own