Automating Tobacco Cessation in Primary Care

NCT07735286 | Not Yet Recruiting

• 1 other identifier: 26-7268
• Study Type: interventional
• Target: 4,800
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study focuses on improving how primary care teams identify patients who smoke and offer access to nicotine replacement therapy, or NRT. NRT includes medications such as nicotine patches, gum, or lozenges that can reduce cravings and support people who are interested in cutting back or quitting smoking. Although NRT is an evidence-based treatment option, it is not always discussed or prescribed during routine primary care visits. To better understand how NRT can be offered in primary care, the project will test a workflow at Penn Family Care that identifies patients who currently smoke and provides information about available tobacco treatment options. Edward Cooper Internal Medicine will serve as a comparison site. Patients who smoke and/or are prescribed NRT will also receive a 30-day follow-up survey to learn whether they received, picked up, or used NRT; whether it was useful; and what barriers they experienced.

Conditions

Tobacco Use; Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

• Proportion of Active Smokers with a Signed NRT Prescription

  The primary outcome will be proportion of patients with a signed NRT prescription (signed between 3 days prior to scheduled visit and 30 days after completed visit) among those documented as active smokers in the EHR as of this visit who did not have an NRT prescription in the 34 to 4 days prior. A sensitivity analysis will include additional patients identified as smokers through pre-visit surveys.

  From 3 days before scheduled visit and 30 days after completed visit.

Secondary Outcomes (12)

• Sensitivity of EHR Active Smoker Designation

  At completion of pre-visit tobacco questionnaire (baseline)

• Specificity of EHR Active Smoker Designation

  At completion of pre-visit tobacco questionnaire (baseline)

• Accuracy of EHR Active Smoker Designation

  At completion of pre-visit tobacco questionnaire (baseline)

• Proportion of Tobacco Questionnaire-Identified Smokers Selecting Each Benefit of Quitting

  At completion of the pre-visit tobacco questionnaire (baseline)

• Proportion of Tobacco Questionnaire-Identified Smokers Selecting Each of the Three Treatments

  At completion of the pre-visit tobacco questionnaire (baseline)

Study Arms (2)

Penn Family Care (Treatment)

EXPERIMENTAL

Interested participants will receive a text with tobacco counseling resources

Behavioral: Tobacco counseling resources

Arm 2: Edward Cooper Internal Medicine (Usual Practice)

NO INTERVENTION

No text with tobacco counseling resources

Interventions

Tobacco counseling resources BEHAVIORAL

Participants who are in the intervention arm will receive tobacco counseling resources via the Way to Health platform. Way to Health will send text message links to tobacco cessation counseling resources (PA Quitline and/or SmokeFreeTXT).

Penn Family Care (Treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Patient at Penn Family Care or Edward Cooper Internal Medicine
• Had an eligible scheduled or completed practice visit categorized as a new annual visit, return patient visit, return annual visit, or return patient sick visit
• For the tobacco cessation intervention: Penn Family Care patient who had not previously completed the tobacco questionnaire
• For the 30-day follow-up survey: Active smoker in the EHR as of the completed visit date or prescribed nicotine replacement therapy (NRT) between 3 days before and 30 days after the completed visit date
• For the primary analysis: Active smoker in the EHR as of the completed visit date
• For the primary analysis: Did not have an NRT prescription between 34 and 4 days before the completed visit date

Sponsors & Collaborators

• University of Pennsylvania: lead

MeSH Terms

Conditions

Tobacco Use; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07