NCT04969978

Brief Summary

This phase IV clinical trial determines the impact of implementing a Quitline electronic (e)Referral system with an enhanced academic detailing implementation strategy on Quitline reach, tobacco cessation assistance and self-reported quit rates among patients in community health centers. It also examines the cost-effectiveness of Quitline eReferrals both with and without enhanced academic detailing. If this implementation strategy is effective, this strategy could be used to increase tobacco cessation treatment through the collaboration between state Quitlines and community health centers that serve large numbers of socioeconomically disadvantaged patients who use tobacco.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9,133

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

July 9, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 20, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2026

Completed
Last Updated

January 28, 2026

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

July 9, 2021

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accepted electronic (e)Referral to Quitline

    Proportion of patients who accepted a Quitline eReferral in intervention (EAD) versus comparator clinics. Will use a logistic mixed effects model that addresses the following design features of the study: 1) will include random intercept for clinic to account for clustering of patients within clinics; 2) will perform an intent-to-treat analysis; 3) hypothesis tests will be two-sided.

    At any point during the 24-month intervention period

Secondary Outcomes (8)

  • Quitline eReferral offered

    At any point during the 24-month intervention period

  • Quitline enrollment

    At any point during the 24-month intervention period

  • Receipt of in-office counseling

    At any point during the 24-month intervention period

  • Tobacco cessation medication ordered

    At any point during the 24-month intervention period

  • Tobacco cessation

    At any point during the 24-month intervention period or up to 6 months post-intervention

  • +3 more secondary outcomes

Other Outcomes (1)

  • Tobacco use assessed

    At any point during the 24-month intervention period

Study Arms (2)

Arm I (Quitline eReferral)

ACTIVE COMPARATOR

Clinics are notified via email that the Quitline eReferral system is available with a link to an online publication that includes an overview of Quitline services, information on Quitline effectiveness, and a detailed eReferral workflow with corresponding EHR screenshots, including how to identify eligible patients, create an eReferral, and access Quitline follow-up data in the EHR. Clinics also gain access to technological assistance, as needed.

Other: Informational Intervention

ARM II (Quitline eReferral plus enhanced AD)

EXPERIMENTAL

Clinics receive standard online materials access to remote technological assistance as in Arm I. Clinics also receive group training of clinic staff prior to activation of the eReferral system and 12 months post-activation, follow-up booster sessions and monthly performance audit and feedback.

Behavioral: Enhanced Academic DetailingOther: Informational Intervention

Interventions

* Group training of clinic staff prior to activation of the eReferral system and 12 months post-activation * Follow-up booster sessions * Monthly performance audit and feedback

Also known as: EAD
ARM II (Quitline eReferral plus enhanced AD)

Receive overview of Quitline services and use of Quitline eReferral via online materials

ARM II (Quitline eReferral plus enhanced AD)Arm I (Quitline eReferral)

Eligibility Criteria

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

You may qualify if:

  • In Oregon
  • On the OCHIN Epic EHR for \>= 1 year
  • Willing to be randomized to the intervention or comparison condition
  • Willing to recruit a provider to serve as a clinic champion (to share monthly performance audit and feedback at all-staff meetings, determine desired content of booster sessions with clinic team members, and complete a survey at the completion of the intervention period) and a clinic manager to coordinate training and booster sessions
  • Adult patients (\>= 18 years of age)
  • Identified as current tobacco users during \>= 1 ambulatory and/or telehealth visit to one of the eligible study clinics over the 24-month study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

SmokingTobacco Use Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Steffani Bailey

    OHSU Department of Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 21, 2021

Study Start

June 20, 2023

Primary Completion

August 22, 2025

Study Completion

February 22, 2026

Last Updated

January 28, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Limited data set was given by partner research organization under data use agreement that excludes disclosure of any data outside of this study.

Locations