Tobacco UseNCT07735286
Automating Tobacco Cessation in Primary Care
A study testing Tobacco counseling resources in people with Tobacco Use and Tobacco Use Cessation, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use, Tobacco Use Cessation
- What is being tested?
- Tobacco counseling resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None except as specified in inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn Medicine
Philadelphia, Pennsylvania, 19104
Senior Project Manager, MSW, 609-534-0751, nathalie.laurent@pennmedicine.upenn.edu
Cheryl Bettigole, MD, MPH
About this study
Official title: Automating Tobacco Cessation in Primary Care Via EHR Integration: A Non-Randomized Trial
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
- Being tested
- Tobacco counseling resources
- Medical subject headings
- Tobacco Use, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco counseling resourcesBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Penn Family Care (Treatment) | Experimental | Interested participants will receive a text with tobacco counseling resources Receives: Behavioral: Tobacco counseling resources |
| Arm 2: Edward Cooper Internal Medicine (Usual Practice) | No intervention | No text with tobacco counseling resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 3 days before scheduled visit and 30 days after completed visit.
Secondary outcomes (12)
Sensitivity of EHR Active Smoker Designation
Sensitivity of EHR active smoker designation using tobacco questionnaire response as benchmark (Treatment-site Secondary Outcome Measure 1)
Measured: At completion of pre-visit tobacco questionnaire (baseline)
Specificity of EHR Active Smoker Designation
Specificity of EHR active smoker designation using tobacco questionnaire response as benchmark (Treatment-site Secondary Outcome Measure 2)
Measured: At completion of pre-visit tobacco questionnaire (baseline)
Accuracy of EHR Active Smoker Designation
Accuracy of EHR active smoker designation using tobacco questionnaire response as benchmark (Treatment-site Secondary Outcome Measure 3)
Measured: At completion of pre-visit tobacco questionnaire (baseline)
Proportion of Tobacco Questionnaire-Identified Smokers Selecting Each Benefit of Quitting
Proportion of tobacco questionnaire-identified smokers who select each benefit of quitting (Treatment-site Secondary Outcome Measure 4)
Measured: At completion of the pre-visit tobacco questionnaire (baseline)
Proportion of Tobacco Questionnaire-Identified Smokers Selecting Each of the Three Treatments
Proportion who select each of the three treatments (Treatment-site Secondary Outcome Measure 5)
Measured: At completion of the pre-visit tobacco questionnaire (baseline)
Proportion of Participants Selecting NRT Whose Clinician Signs the Pended Order
Proportion selecting NRT whose clinician signs the pended order (Treatment-site Secondary Outcome Measure 6)
Measured: From completion of the pre-visit tobacco questionnaire through 30-days after the completed visit
Proportion of Participants With Any NRT Prescription Recorded in the EHR
Any NRT prescription in the EHR during the study period (Both-sites Secondary Outcome Measure 7)
Measured: From study start for first participant to 6 months later
Proportion of Participants Reporting NRT Use at 30-Day Follow-Up
30-day self-reported NRT use (Both-sites Secondary Outcome Measure 8)
Measured: 30 days after completed visit, at time of follow-up survey completion
Proportion of Participants Reporting Engagement With Tobacco Cessation Counseling Resources at 30-Day Follow-Up
30-day self-reported engagement with tobacco cessation counseling resources (Both-sites Secondary Outcome Measure 9)
Measured: 30 days after completed visit, at time of follow-up survey completion
Proportion of Participants Reporting Each Smoking Status at 30-Day Follow-Up
30-day self-reported smoking status (Both-sites Secondary Outcome Measure 10)
Measured: 30 days after completed visit, at time of follow-up survey completion
Proportion of Participants Reporting Changes in Smoking Behavior at 30-Day Follow-Up
30-day self-reported changes in smoking behavior (Both-sites Secondary Outcome Measure 11)
Measured: 30 days after completed visit, at time of follow-up survey completion
Proportion of Participants With a New or Refill NRT Prescription Recorded in the EHR
New/refill NRT prescription in EHR 30-60 days after completed visit (Both-sites Secondary Outcome Measure 12)
Measured: 30 to 60 days after the completed visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start24 Sep 2026
- Primary completion23 Mar 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Bettigole, MD, MPH, Principal investigator, Penn MedicineJennifer Lee, MD, Principal investigator, Penn MedicineMucio (Kit) Delgado, MD, MS, Principal investigator, Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735286
- Sponsor's protocol ID
- 26-7268
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automating Tobacco Cessation in Primary Care Via EHR Integration: A Non-Randomized Trial
- ClinicalTrials.gov ID
- NCT07735286
- Acronym / sponsor ID
- 26-7268
- Conditions
- Tobacco Use, Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penn Family Care (Treatment) | Experimental | Behavioral: Tobacco counseling resourcesInterested participants will receive a text with tobacco counseling resources |
| Arm 2: Edward Cooper Internal Medicine (Usual Practice) | No intervention | –No text with tobacco counseling resources |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- None except as specified in inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco counseling resourcesParticipants 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). | Behavioural | Penn Family Care (Treatment) |
Primary outcome
Proportion of Active Smokers with a Signed NRT Prescription
Time frame: From 3 days before scheduled visit and 30 days after completed visit.
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.
12 secondary outcomes
Sensitivity of EHR Active Smoker Designation
Time frame: At completion of pre-visit tobacco questionnaire (baseline)
Specificity of EHR Active Smoker Designation
Time frame: At completion of pre-visit tobacco questionnaire (baseline)
Accuracy of EHR Active Smoker Designation
Time frame: At completion of pre-visit tobacco questionnaire (baseline)
Proportion of Tobacco Questionnaire-Identified Smokers Selecting Each Benefit of Quitting
Time frame: At completion of the pre-visit tobacco questionnaire (baseline)
Proportion of Tobacco Questionnaire-Identified Smokers Selecting Each of the Three Treatments
Time frame: At completion of the pre-visit tobacco questionnaire (baseline)
Proportion of Participants Selecting NRT Whose Clinician Signs the Pended Order
Time frame: From completion of the pre-visit tobacco questionnaire through 30-days after the completed visit
Proportion of Participants With Any NRT Prescription Recorded in the EHR
Time frame: From study start for first participant to 6 months later
Proportion of Participants Reporting NRT Use at 30-Day Follow-Up
Time frame: 30 days after completed visit, at time of follow-up survey completion
Proportion of Participants Reporting Engagement With Tobacco Cessation Counseling Resources at 30-Day Follow-Up
Time frame: 30 days after completed visit, at time of follow-up survey completion
Proportion of Participants Reporting Each Smoking Status at 30-Day Follow-Up
Time frame: 30 days after completed visit, at time of follow-up survey completion
Proportion of Participants Reporting Changes in Smoking Behavior at 30-Day Follow-Up
Time frame: 30 days after completed visit, at time of follow-up survey completion
Proportion of Participants With a New or Refill NRT Prescription Recorded in the EHR
Time frame: 30 to 60 days after the completed visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheryl Bettigole, MD, MPH principal investigator
Penn Medicine
Jennifer Lee, MD principal investigator
Penn Medicine
Mucio (Kit) Delgado, MD, MS principal investigator
Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco counseling resources in people with Tobacco Use and Tobacco Use Cessation, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Project Manager, MSW (609-534-0751, nathalie.laurent@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Active Smokers with a Signed NRT Prescription (time frame: From 3 days before scheduled visit and 30 days after completed visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.