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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: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.

NCT04199117 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 210 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over 1-year of study enrollment period, vs. 0=no evidence of treatment initiation).

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

FieldValue
Enrollment Target 210 participants
Start Date 2020-03-11
Est. Completion 2024-10-16
Phase Phase 4
University of Wisconsin, Madison

1,039 total trials

What the finished NCT04199117 record still lists

NCT04199117 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower).

The record links to 0 conditions, and to 5 interventions - of which Varenicline is the first listed.

NCT04199117 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04199117's enrollment target sits among peer trials

210 398th of 2000 higher than 1,602 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04199117, the US trial registry maintained by the National Library of Medicine. NCT04199117 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.