Tobacco-Related CarcinomaCONNECTNCT04969978
Electronic Quitline Referral With Enhanced Academic Detailing for the Promotion of Smoking Cessation
A study testing Enhanced Academic Detailing and Informational Intervention in people with Tobacco-Related Carcinoma and Smoking &Amp; Tobacco Cessation, run by OHSU Knight Cancer Institute at 1 site in United States.
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, tobacco cessation assistance and self-reported quit rates among patients in community health centers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco-Related Carcinoma, Smoking &Amp; Tobacco Cessation
- What is being tested?
- Enhanced Academic Detailing and Informational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,133 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 22 Feb 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 26-month study period
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: 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, 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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 tobacco cessation medication, and receipt of in-clinic counseling among patients identified as currently using tobacco.
II. Assess the effectiveness of implementing a Quitline eReferral system with enhanced AD (intervention) versus without enhanced AD (comparison) on self-reported tobacco quit rates among all patients identified as current persons using tobacco 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.
- Being tested
- Enhanced Academic Detailing, Informational Intervention
- Medical subject headings
- Smoking, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Academic DetailingBehavioural
Also called EAD
- 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
Informational InterventionOther
Receive overview of Quitline services and use of Quitline eReferral via online materials
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Academic Detailing; Other: Informational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Accepted Electronic (e)Referral to Quitline
Number of patients who accepted a Quitline eReferral in intervention (EAD) versus comparator clinics among those using tobacco.
Measured: At any point during the 26-month intervention period
Secondary outcomes (7)
Quitline eReferral Offered
Number of patients who were offered the Quitline eReferral.
Measured: At any point during the 26-month intervention period
Quitline Enrollment
Number of patients who accepted the Quitline eReferral and enrolled in Quitline services.
Measured: At any point during the 26-month intervention period
Receipt of In-office Counseling
Number of patients with an indication in the electronic health record (EHR) of receipt of counseling during an office visit.
Measured: At any point during the 26-month intervention period
Tobacco Cessation Medication Ordered
Number of patients with a tobacco cessation medication in the 'medication orders' list of the EHR.
Measured: At any point during the 26-month intervention period
Tobacco Cessation
Number of patients with EHR status change from current to former tobacco use.
Measured: At any point during the 26-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.
Measured: Years 1-4
Cost-effectiveness
Mean total annual costs over years 1-4 by study arm, overall and for patients enrolled in the Quitline.
Measured: Years 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start20 Jun 2023
- Primary completion22 Aug 2025
- Study completion22 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,133 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, OCHIN, Inc., Oregon Health and Science University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Steffani Bailey, Oregon Health and Science University
- Investigators
- Steffani Bailey, Principal investigator, OHSU Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969978
- Sponsor's protocol ID
- STUDY00023019
- Other IDs
- NCI-2021-06581, STUDY00023019, R01CA255016
- Acronym
- CONNECT
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2021
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Limited data set was given by partner research organization under data use agreement that excludes disclosure of any data outside of this study.