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Automating Tobacco Cessation in Primary Care

Automating Tobacco Cessation in Primary Care Via EHR Integration: A Non-Randomized Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07735286
Enrollment
4800
Registered
2026-07-29
Start date
2026-09-01
Completion date
2027-08-01
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use, Tobacco Use Cessation

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.

Interventions

BEHAVIORALTobacco counseling resources

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).

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* None except as specified in inclusion criteria.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Active Smokers with a Signed NRT PrescriptionFrom 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.

Secondary

MeasureTime frameDescription
Sensitivity of EHR Active Smoker DesignationAt completion of pre-visit tobacco questionnaire (baseline)Sensitivity of EHR active smoker designation using tobacco questionnaire response as benchmark (Treatment-site Secondary Outcome Measure 1)
Specificity of EHR Active Smoker DesignationAt completion of pre-visit tobacco questionnaire (baseline)Specificity of EHR active smoker designation using tobacco questionnaire response as benchmark (Treatment-site Secondary Outcome Measure 2)
Accuracy of EHR Active Smoker DesignationAt completion of pre-visit tobacco questionnaire (baseline)Accuracy of EHR active smoker designation using tobacco questionnaire response as benchmark (Treatment-site Secondary Outcome Measure 3)
Proportion of Tobacco Questionnaire-Identified Smokers Selecting Each Benefit of QuittingAt completion of the pre-visit tobacco questionnaire (baseline)Proportion of tobacco questionnaire-identified smokers who select each benefit of quitting (Treatment-site Secondary Outcome Measure 4)
Proportion of Tobacco Questionnaire-Identified Smokers Selecting Each of the Three TreatmentsAt completion of the pre-visit tobacco questionnaire (baseline)Proportion who select each of the three treatments (Treatment-site Secondary Outcome Measure 5)
Proportion of Participants Selecting NRT Whose Clinician Signs the Pended OrderFrom completion of the pre-visit tobacco questionnaire through 30-days after the completed visitProportion selecting NRT whose clinician signs the pended order (Treatment-site Secondary Outcome Measure 6)
Proportion of Participants With Any NRT Prescription Recorded in the EHRFrom study start for first participant to 6 months laterAny NRT prescription in the EHR during the study period (Both-sites Secondary Outcome Measure 7)
Proportion of Participants Reporting NRT Use at 30-Day Follow-Up30 days after completed visit, at time of follow-up survey completion30-day self-reported NRT use (Both-sites Secondary Outcome Measure 8)
Proportion of Participants Reporting Engagement With Tobacco Cessation Counseling Resources at 30-Day Follow-Up30 days after completed visit, at time of follow-up survey completion30-day self-reported engagement with tobacco cessation counseling resources (Both-sites Secondary Outcome Measure 9)
Proportion of Participants Reporting Each Smoking Status at 30-Day Follow-Up30 days after completed visit, at time of follow-up survey completion30-day self-reported smoking status (Both-sites Secondary Outcome Measure 10)
Proportion of Participants Reporting Changes in Smoking Behavior at 30-Day Follow-Up30 days after completed visit, at time of follow-up survey completion30-day self-reported changes in smoking behavior (Both-sites Secondary Outcome Measure 11)
Proportion of Participants With a New or Refill NRT Prescription Recorded in the EHR30 to 60 days after the completed visitNew/refill NRT prescription in EHR 30-60 days after completed visit (Both-sites Secondary Outcome Measure 12)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026