Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04199117 · ClinicalTrials.gov registry record · Phase 4
Health Systems Reach Interventions Project
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 210
- Enrollment target
NCT04199117 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 210 participants.
The verdict
NCT04199117, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 210 participants
- Enrollment target
Study Summary
This project seeks to identify ways to enhance the reach of evidence-based smoking cessation treatments among adult primary care patients who smoke daily and are not ready to start treatment at study enrollment. The 2x2x2x2 factorial experiment will evaluate the extent to which 4 intervention components promote the use of evidence-based treatments to help smokers not initially ready to quit to cease smoking over 2 years. The intervention components tested include: modest financial incentives for completing an initial counseling session in a smoking cessation treatment (vs. none); automated semi-annual outreach materials sent via patients' preferred communication modality using data in the electronic health record to tailor and personalize invitations to use available treatments to quit smoking (vs. untailored letters); direct, proactive telephone outreach from a tobacco care manager who will promote treatment use and deliver motivational intervention twice per year (vs. none); and access to 3 no-cost telephone smoking cessation counseling calls with combination nicotine replacement therapy (C-NRT) or varenicline (vs. state tobacco quitline and primary care provider referral). Proactive treatment offers will be made up to 22 months after enrollment. Smoking status and use of any smoking cessation treatments will be assessed every 6 months through 2 years of study enrollment. Data from 1664 adult primary care patients meeting inclusion/exclusion criteria will be analyzed to see whether the intervention components have an effect on the use of treatment (primary outcome) and smoking status after 2 years of treatment access (secondary outcome). The project will evaluate the manipulated intervention components first in terms of treatment initiation (defined as rates of completing at least 1 smoking cessation counseling session prior to a target stop-smoking date), and then in terms of end-of-study (2 year post-enrollment) abstinence rates (secondary outcome), and cost-eff
Interventions
- DRUG Varenicline
- BEHAVIORAL Care management
- DRUG Combination nicotine patch and nicotine mini-lozenge treatment
- BEHAVIORAL Monetary incentives for initiating treatment
- BEHAVIORAL Automated tailored outreach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2020-03-11 |
| Est. Completion | 2024-10-16 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04199117
The ClinicalTrials.gov registry entry for NCT04199117 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Varenicline is the first listed.
NCT04199117 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04199117 about?
NCT04199117 is a clinical study titled "Health Systems Reach Interventions Project". This project seeks to identify ways to enhance the reach of evidence-based smoking cessation treatments among adult primary care patients who smoke daily and are not ready to start treatment at study enrollment. The 2x2x2x2 factorial experiment will evaluate the extent to which 4 intervention compon...
What is the current status of trial NCT04199117?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 210 participants. The study started on 2020-03-11. Estimated completion is 2024-10-16.
What interventions are being tested in trial NCT04199117?
The interventions under investigation include: Varenicline (DRUG), Care management (BEHAVIORAL), Combination nicotine patch and nicotine mini-lozenge treatment (DRUG), Monetary incentives for initiating treatment (BEHAVIORAL), Automated tailored outreach (BEHAVIORAL).
Who is sponsoring clinical trial NCT04199117?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.