Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846841
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-04-21
Brief Title:
Personalized Tobacco Treatment in Primary Care MOTIVATE
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Multilevel Intervention to Personalize and Improve Tobacco Treatment in Primary Care MOTIVATE
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients clinical genetic and biomarker information This approach may increase effectiveness and adherence for the patient and increase the clinicians likelihood of prescribing
Detailed Description:
The overarching goal of this study is to test the impact of a multilevel precision treatment intervention aiming to address gaps in clinician and patient uptake of tobacco treatment and overall treatment effectiveness This study builds on evidence that 1 genetic and metabolic factors may inform precision tobacco treatment and 2 increasingly high demand for precision treatment in particular may signal its potential to activate behavior change The multilevel precision treatment intervention to be tested--PrecisionTx-- provides the opportunity to present personalized risk benefit and treatment recommendation to increase clinician ordering patient uptake and overall effectiveness of tobacco treatment This study aims to understand the relative benefit of precision treatment over usual care and associated mechanistic and implementation outcomes Therefore the investigators propose a 2-arm cluster randomized controlled trial of 50 clinicians and 800 screen-eligible patients 16 per clinician from diverse primary care settings Clinicians and patients will be randomized with 11 allocation to usual care UC vs precision treatment PT to evaluate the effect of precision treatment on smoking cessation success In Aim 1 the investigators will test the effect of PT on clinician prescribing or patient receipt of medication when prescription is not needed and patient use of medication for smoking cessation The investigators hypothesize that patient receipt of tobacco treatment medication for smoking cessation at 6 months post-intervention will be higher in PT vs UC The investigators also hypothesize that patient use of cessation medication at 6 months post-intervention will be higher in PT vs UC In Aim 2 the investigators will test the effect of PT on patient smoking abstinence The investigators hypothesize that patient bioverified smoking abstinence at 6 months will be higher in PT vs UC In Aim 3 the investigators will examine mechanisms of behavior change and implementation outcomes The investigators will evaluate putative mechanisms for PT eg outcome expectancy and withdrawal suppression The investigators will conduct assessments at baseline intervention and 1-month 3-month 6-month and 12-month post-intervention follow-ups
Primary outcomes include patient receipt of tobacco treatment patient use of tobacco treatment and patient smoking abstinence Secondary outcomes include patient receipt of recommended medication patient medication adherence and additional patient smoking cessation outcomes Mechanistic outcomes include clinician level perceived benefit outcome expectancy clinician-patient interaction self-efficacy patient-level perceived risk outcome expectancy withdrawal suppression adverse events Implementation outcomes will be evaluated based on the RE-AIM framework The study is an innovative paradigm shift from a traditional treatment model to precision treatment that includes both metabolic and genetic markers to motivate and guide tobacco treatment for both clinicians and patients integrated within primary care
Smoking is a leading cause of premature death causing more than half of all cancer deaths However tobacco treatment is often not provided and is not highly effective in primary care New evidence suggests that a precision treatment approach to motivate and guide treatment based on personal genetic and metabolic markers could improve treatment uptake and quit success This study will test the impact of a multilevel precision treatment intervention on improving tobacco treatment and health outcomes in primary care
Primary outcomes include patient receipt of tobacco treatment patient use of tobacco treatment and patient smoking abstinence Secondary outcomes include patient receipt of recommended medication patient medication adherence and additional patient smoking cessation outcomes Mechanistic outcomes include clinician level perceived benefit outcome expectancy clinician-patient interaction self-efficacy patient-level perceived risk outcome expectancy withdrawal suppression adverse events Implementation outcomes will be evaluated based on the RE-AIM framework The study is an innovative paradigm shift from a traditional treatment model to precision treatment that includes both metabolic and genetic markers to motivate and guide tobacco treatment for both clinicians and patients integrated within primary care
Smoking is a leading cause of premature death causing more than half of all cancer deaths However tobacco treatment is often not provided and is not highly effective in primary care New evidence suggests that a precision treatment approach to motivate and guide treatment based on personal genetic and metabolic markers could improve treatment uptake and quit success This study will test the impact of a multilevel precision treatment intervention on improving tobacco treatment and health outcomes in primary care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DA056050 | NIH | None | httpsreporternihgovquickSearch1R01DA056050 |