Personalized Tobacco Treatment in Primary Care (MOTIVATE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
This study examines the application of precision treatment intervention for smoking cessation from both the clinician perspective and patient perspective, and compares it to usual care on tobacco treatment in the primary care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This approach may increase effectiveness and adherence for the patient, and increase the clinician's likelihood of prescribing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinician from participating clinic
At least 18 years of age
Can speak and understand English
Patient at participating clinic
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Precision Treatment
BehavioralPrecision treatment will be informed by practice guidelines (standard of care, brief advice, and guideline awareness), plus patient-specific risk feedback and personalized tobacco treatment recommendations using patients' clinical, genetic, and biomarker information.
Usual Care
BehavioralUsual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).
Treatment groups
850 Participants
are divided into 2 treatment groupsGroup A: Usual CareActive comparator 1 intervention
Group B: PrecisionTxExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient receipt of tobacco treatment medication for smoking cessation
This will be quantified by the proportion of enrolled patients who receive cessation medication.
Time frame
6 months post-intervention2
Patient use of cessation medication
This will be quantified by the proportion of patients taking any cessation medication from time of enrollment through 6 months post-intervention.
Time frame
6 months post-intervention3
Patient smoking abstinence
This will be quantified by the proportion of smokers with bioverified point-prevalent abstinence at 6 months.
Time frame
6 months post-interventionSecondary outcomes
1
Patient receipt of recommended tobacco treatment
This will be quantified by the proportion of enrolled patients who received recommended cessation medication.
Time frame
6 months post-intervention2
Patient medication adherence
This will be quantified by the proportion of medication taken among medication prescribed.
Time frame
6 months post-intervention3
Patient smoking abstinence among treated
This will be quantified by the proportion of smokers with bioverified point-prevalence abstinence among those receiving cessation medication.
Time frame
6 months post-intervention4
Abstinence Outcomes Across Multiple Time Points
The outcome measures abstinence (self-reported no smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment) over these time points.
Time frame
From intervention through 12 months post-interventionOther outcomes
1
Perceived benefits (Clinician)
Clinicians' perceived importance and benefits of patients receiving smoking cessation medications will be assessed using a modified version of the Beliefs and Attitudes About Bupropion Scale.
Time frame
Exit interview [after clinician has been enrolled in the trial for approximately 6 months]2
Outcome expectancies (Clinician)
Clinicians' outcome expectancies regarding tobacco treatment will be assessed using a modified version of the Stanford Expectation of Treatment Scale.
Time frame
Exit interview [after clinician has been enrolled in the trial for approximately 6 months]3
Self-efficacy regarding patient-clinician interaction (Clinician)
Clinicians' perceived self-efficacy regarding patient-clinician communication will be assessed using a modified version of the Communication Perceived Self-Efficacy Scale.
Time frame
Exit interview [after clinician has been enrolled in the trial for approximately 6 months]4
Self-efficacy regarding patient-clinician interaction (Patient)
Patients' perceived self-efficacy regarding patient-clinician communication will be assessed using a modified version of the Communication Perceived Self-Efficacy Scale.
Time frame
From intervention through 12 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov