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Not yet recruiting NCT07735286

Automating Tobacco Cessation in Primary Care

No phase Interventional Tobacco Use Tobacco Use Cessation

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: Tobacco counseling resources.
Who it may be relevant to
Registry conditions: Tobacco Use, Tobacco Use Cessation. 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
Center list to be confirmed — check the primary protocol.
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 →

Official title

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

Overview

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

  • Behavioral Tobacco 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).

Primary outcome measures

  • Proportion of Active Smokers with a Signed NRT Prescription [Time frame: From 3 days before scheduled visit and 30 days after completed visit.]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

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

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07735286 · 26-7268

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗