Electronic Quitline Referral With Enhanced Academic Detailing for the Promotion of Smoking Cessation (CONNECT)

CONNECT: COmpreheNsive TraiNing and Engagement in Cessation Treatment

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, smoking 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 smoking cessation treatment through the collaboration between state Quitlines and community health centers that serve large numbers of socioeconomically disadvantaged smokers.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation; Tobacco-Related Carcinoma
• Intervention / Treatment: Other: Informational Intervention; Behavioral: Enhanced Academic Detailing

Detailed Description

PRIMARY OBJECTIVES:

I. Implement a Quitline electronic (e)Referral system with enhanced academic detailing (AD) (intervention; n=10 community health centers [CHCs]) and without enhanced AD (comparison; n=10 CHCs) to compare rates of eReferral offers, eReferral acceptance, Quitline enrollment, orders for smoking cessation medication, and receipt of in-clinic counseling among patients identified as current smokers.

II. Assess the effectiveness of implementing a Quitline eReferral system with enhanced AD (intervention) versus without enhanced AD (comparison) on self-reported smoking quit rates among all patients identified as current smokers using electronic health record (EHR) data.

III. Estimate the total annual costs and incremental cost-effectiveness of a Quitline eReferral system, with and without enhanced AD.

OUTLINE: Clinics are randomized to 1 of 2 arms.

ARM I: Clinics are notified via email that the 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 electronic health record (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.

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

• Study Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Study Clinic Inclusion Criteria:

• 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

Study Patient Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (Quitline eReferral); 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; Receive overview of Quitline services and use of Quitline eReferral via online materials
Experimental: ARM II (Quitline eReferral plus enhanced AD); 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.	Other: Informational Intervention; Receive overview of Quitline services and use of Quitline eReferral via online materials; Behavioral: Enhanced Academic Detailing; 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; Other Names: EAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accepted electronic (e)Referral to Quitline	Proportion of patients who were offered and accepted the 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 intercepts for providers and clinic to account for clustering of patients within providers 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quitline eReferral offered	Proportion of patients who were offered the Quitline eReferral in intervention (EAD) versus comparator clinics. Will construct similar logistic mixed effects models.	At any point during the 24-month intervention period
Quitline enrollment	Proportion of patients who were offered the Quitline eReferral and enrolled in Quitline services in intervention (EAD) versus comparator clinics. Will construct similar logistic mixed effects models.	At any point during the 24-month intervention period
Receipt of in-office counseling	Proportion of patients with an indication in the electronic health record (EHR) of receipt of counseling during an office visit in intervention (EAD) versus comparator clinics. Will construct similar logistic mixed effects models.	At any point during the 24-month intervention period
Smoking cessation medication ordered	Proportion of patients with a smoking cessation medication in the 'medication orders' list of the EHR in intervention (EAD) versus comparator clinics. Will construct similar logistic mixed effects models.	At any point during the 24-month intervention period
Smoking cessation	Proportion of patients with EHR status change from current to former smoker. Will utilize similar generalized linear mixed model (GLMM) modeling to estimate the impact of the intervention on cessation outcomes.	At any point during the 24-month intervention period or up to 6 months post-intervention
Annual intervention costs	Mean total annual costs in years 1-4 to implement the eReferral into the EHR and maintain eReferral system, with and without enhanced academic detailing.	Years 1-4
Cost-effectiveness	Mean total annual costs over years 1-4 by study arm, overall and for patients enrolled in the Quitline.	Years 1-4
Incremental cost-effectiveness ratio	Difference in total costs by study arm, overall and for patients enrolled in Quitline.	Years 1-4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco use assessed	Proportion of patients who had a current tobacco use assessment in intervention (EAD) versus comparator clinics.	At any point during the 24-month intervention period

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Cancer Institute (NCI); Oregon Health and Science University; Kaiser Permanente; OCHIN, Inc.
• Investigators: Principal Investigator: Steffani Bailey, OHSU Department of Family Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00023019 (OHSU Knight Cancer Institute); NCI-2021-06581 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA255016 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No