Automating Tobacco Cessation in Primary Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None except as specified in inclusion criteria.
Trial design
Design model
Parallel
Treatments tested in this trial
Tobacco counseling resources
BehavioralParticipants 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).
Treatment groups
4,800 Participants
are divided into 2 treatment groupsGroup A: Penn Family Care (Treatment)Experimental treatment 1 intervention
Group B: Arm 2: Edward Cooper Internal Medicine (Usual Practice)No intervention 0 interventions
Trial outcomes
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.
Time frame
From 3 days before scheduled visit and 30 days after completed visit.Secondary outcomes
1
Sensitivity of EHR Active Smoker Designation
Sensitivity of EHR active smoker designation using tobacco questionnaire response as benchmark (Treatment-site Secondary Outcome Measure 1)
Time frame
At completion of pre-visit tobacco questionnaire (baseline)2
Specificity of EHR Active Smoker Designation
Specificity of EHR active smoker designation using tobacco questionnaire response as benchmark (Treatment-site Secondary Outcome Measure 2)
Time frame
At completion of pre-visit tobacco questionnaire (baseline)3
Accuracy of EHR Active Smoker Designation
Accuracy of EHR active smoker designation using tobacco questionnaire response as benchmark (Treatment-site Secondary Outcome Measure 3)
Time frame
At completion of pre-visit tobacco questionnaire (baseline)4
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)
Time frame
At completion of the pre-visit tobacco questionnaire (baseline)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: