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

Smoking Cessation Clinical Trial

— CONNECT  

Official title:

CONNECT: COmpreheNsive TraiNing and Engagement in Cessation Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04969978
• Other study ID #: STUDY00023019
• Secondary ID: NCI-2021-06581ST
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: January 2024
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco-Related Carcinoma

Intervention

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:
• Informational Intervention
Receive overview of Quitline services and use of Quitline eReferral via online materials

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (5)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Kaiser Permanente, National Cancer Institute (NCI), OCHIN, Inc., Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost-effectiveness	Mean total annual costs over years 1-4 by study arm, overall and for patients enrolled in the Quitline.	Years 1-4
Secondary	Incremental cost-effectiveness ratio	Difference in total costs by study arm, overall and for patients enrolled in Quitline.	Years 1-4