Clinical trial NCT06582693: Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
Official title: Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Smoking Cessation
Second Hand Tobacco Smoke
Keywords: Smoking
Smoking Cessation
Second Hand Tobacco Smoke
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2024-09-03
Enrollment: 3200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.

Eligibility 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

Primary outcomes:
measure: The proportion of adult participants who engage in any evidence-based tobacco use treatments
timeFrame: Baseline, 1 and 6 months
measure: Combustible tobacco quit rate at 1 and 6 months
timeFrame: 1 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Brian P Jenssen, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: