Clinical trial NCT04969978: Electronic Quitline Referral with Enhanced Academic Detailing for the Promotion of Smoking Cessation
Official title: CONNECT: COmpreheNsive TraiNing and Engagement in Cessation Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tobacco-Related Carcinoma
Smoking Cessation
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: OCHIN, Inc.
name: Oregon Health and Science University
name: National Cancer Institute (NCI)
First posted: 2021-07-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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, 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accepted electronic (e)Referral to Quitline
timeFrame: At any point during the 24-month intervention period
Secondary outcomes:
measure: Quitline eReferral offered
timeFrame: At any point during the 24-month intervention period
measure: Quitline enrollment
timeFrame: At any point during the 24-month intervention period
measure: Receipt of in-office counseling
timeFrame: At any point during the 24-month intervention period
measure: Smoking cessation medication ordered
timeFrame: At any point during the 24-month intervention period
measure: Smoking cessation
timeFrame: At any point during the 24-month intervention period or up to 6 months post-intervention
measure: Annual intervention costs
timeFrame: Years 1-4
measure: Cost-effectiveness
timeFrame: Years 1-4
measure: Incremental cost-effectiveness ratio
timeFrame: Years 1-4
Other outcomes:
measure: Tobacco use assessed
timeFrame: At any point during the 24-month intervention period
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Department of Family Medicine
name: Steffani Bailey
role: PRINCIPAL_INVESTIGATOR
References: