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Recruiting NCT06582693

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

No phase Interventional Smoking Smoking Cessation Second Hand Tobacco Smoke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Refer2Quit.
Who it may be relevant to
Registry conditions: Smoking, Smoking Cessation, Second Hand Tobacco Smoke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Refer2Quit
    The Refer2Quit intervention consists of automatic connection to the adult participant's choice of any or all of four evidence-based tobacco treatment options (varenicline, NRT, quitline, and/or smokefreeTXT), as well as motivational counseling provided by the study team. Supportive and motivational text messaging is also included in the intervention to connect or reconnect adult participants to treatments as needed. Text messaging and support would also focus on supporting appropriate use of NRT

Primary outcome measures

  • The proportion of adult participants who engage in any evidence-based tobacco use treatments [Time frame: Baseline, 1 and 6 months]
  • Combustible tobacco quit rate at 1 and 6 months [Time frame: 1 and 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Children's Hospital of Philadelphia — Philadelphia

Identifiers

NCT: NCT06582693 · 23-021075 · 1R37CA282153-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗