NCT05612152

Brief Summary

The goal of this study is to evaluate the effectiveness of a tobacco treatment navigator to improve primary care patient engagement in tobacco cessation support. We compare an ask, advise and connect to the quitline approach vs. the novel tobacco treatment navigator approach on the primary outcomes of receipt of tobacco cessation counseling sessions and receipt of tobacco cessation medications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

November 3, 2022

Last Update Submit

November 3, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • receipt of tobacco cessation counseling

    receipt of 1 or more tobacco cessation counseling sessions from referral sources

    4 weeks after referral

  • receipt of tobacco cessation medications

    documentation of orders for nicotine replacement therapy, varenicline or bupropion in electronic health record

    within 4 weeks after referral

Secondary Outcomes (1)

  • 7-day point prevalence abstinence

    8 weeks after referral

Study Arms (2)

Referral to Quitline

ACTIVE COMPARATOR

Patients who indicate they are ready to quit in the next 30 days are offered an electronic referral to the state quitline for tobacco cessation services.

Other: Referral to Quitline

Choose2Quit

EXPERIMENTAL

Patients who indicate they are ready to quit in the next 30 days are offered an electronic referral to the Choose2Quit tobacco treatment navigator who walks the patient through choices for tobacco cessation counseling, tobacco cessation medications and other supports (e.g. texting, apps) and facilitates placing referrals, orders and providing information.

Other: Choose2Quit

Interventions

An electronic referral to the state quitline is placed. This prompts the quitline to proactively call the patient to enroll in counseling services.

Referral to Quitline

An electronic referral to the Choose2quit tobacco cessation navigator is placed. This prompts the navigator to call the patient to review options for tobacco cessation counseling, tobacco cessation medications and other supports.

Choose2Quit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient care visit to one of the participating primary care clinics during the study period
  • reports current tobacco use
  • reports interest in quitting tobacco in the next 30 days
  • accepts offer of referral to tobacco cessation support

You may not qualify if:

  • not interested in quitting in next 30 days
  • not interested in assistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Susan Flocke

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 10, 2022

Study Start

November 1, 2022

Primary Completion

February 28, 2024

Study Completion

July 31, 2024

Last Updated

November 10, 2022

Record last verified: 2022-11