Enhanced Quitline Support for Smoking Cessation

(CONNECT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Under 18, Non-tobacco users, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help people quit smoking using a Quitline eReferral system. One group receives basic information and technology assistance, while the other group also gets extra training and regular feedback through an enhanced academic detailing approach. The researchers aim to determine if these methods can increase the number of successful quitters and identify which method is more cost-effective. Adults who currently smoke and have visited one of the participating community health centers in Oregon may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance smoking cessation support for many.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research has shown that Enhanced Academic Detailing and Quitline eReferral systems are generally safe. Enhanced Academic Detailing trains healthcare providers to better assist patients in quitting smoking. While detailed safety data is not provided, this method is widely used and considered low-risk. Quitline services offer phone support to help people stop smoking. These services have been used for years and are known to be safe and effective. In conclusion, both methods are well-tolerated and focus on providing guidance and support rather than medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative support methods for helping people quit smoking. The trial includes an enhanced Quitline eReferral system, which not only provides clinics with standard online materials and tech support but also involves group training for clinic staff and regular performance feedback. This approach could boost the effectiveness of smoking cessation efforts by integrating more comprehensive support and continuous staff development, potentially leading to better patient outcomes. Unlike existing treatments that mainly focus on medication or minimal counseling, this method emphasizes structured, ongoing engagement and follow-up.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that using an electronic referral system for Quitline can help people stop smoking. In this trial, participants in Arm I will use the standard Quitline eReferral system. Arm II will include the Quitline eReferral system plus enhanced training and feedback for clinic staff. Studies have found that extra training and feedback for clinic staff make these referrals even more effective. This additional training has increased the number of patients who use Quitline services. Specifically, patients have demonstrated better success in quitting smoking when clinics employ these methods. The extra training ensures that more patients receive the support they need to quit smoking. ^{1 3 6 7 8}

Who Is on the Research Team?

Steffani Bailey

Principal Investigator

OHSU Department of Family Medicine

Are You a Good Fit for This Trial?

This trial is for adult tobacco users (18+) who have visited eligible study clinics in Oregon during a 24-month period. Participants must be willing to recruit a clinic champion and manager, agree to randomization, and their clinic should use the OCHIN Epic EHR system for at least one year.

Inclusion Criteria

Study Patient: 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 Clinic: Willing to recruit a provider to serve as a clinic champion and a clinic manager

Study Clinic: On the OCHIN Epic EHR for >= 1 year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of Quitline eReferral system with and without enhanced academic detailing in community health centers

24 months

Monthly performance audit and feedback sessions

Follow-up

Participants are monitored for smoking cessation outcomes and cost-effectiveness

6 months

Cost-effectiveness Analysis

Assessment of the total annual costs and incremental cost-effectiveness of the Quitline eReferral system

Years 1-4

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Academic Detailing
• Informational Intervention

Trial Overview The trial tests an electronic Quitline referral system with enhanced academic detailing to see if it helps more people quit smoking. It compares how effective this strategy is against usual care in community health centers, also looking into its cost-effectiveness.

How Is the Trial Designed?

Group I: ARM II (Quitline eReferral plus enhanced AD) Experimental Treatment 2 Interventions

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.

Group II: Arm I (Quitline eReferral) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

OCHIN, Inc.

Collaborator

Trials

24

Recruited

9,964,000+

Published Research Related to This Trial

In a randomized controlled trial involving 453 parents and caregivers, a tailored cessation intervention for smokers resulted in a significant increase in self-reported smoking abstinence over time, with 40.6% of participants remaining abstinent by year 4 compared to only 13.2% in the control group.

The intervention also led to a notable decrease in saliva cotinine levels (a marker of tobacco exposure) from baseline to year 4, indicating reduced tobacco smoke exposure for children in families participating in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Smoking Cessation: Impacting Children's Tobacco Smoke Exposure in the Home. Caldwell, AL., Tingen, MS., Nguyen, JT., et al.[2019]

A study involving 600 hospitalized smokers tested a brief intervention to facilitate access to telephone quitline services, but found no difference in 6-month abstinence rates compared to standard cessation advice, with both groups reporting a 24% abstinence rate.

Despite 65% of the intervention group completing the quitline intake call, the facilitation intervention did not enhance the effectiveness of quitlines for helping hospitalized smokers quit, suggesting that quitlines may not be a viable solution for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quitline Tobacco Interventions in Hospitalized Patients: A Randomized Trial. Warner, DO., Nolan, MB., Kadimpati, S., et al.[2018]

A randomized clinical trial involving 233 very low-income smokers showed that telephonic counseling significantly improved smoking cessation rates, with 21% of participants quitting compared to 8.1% in the usual care group.

The study suggests that individualized telephonic counseling is effective for low-income smokers, indicating that Medicaid managed care plans should invest in such support services to enhance smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing smoking cessation of low-income smokers in managed care. Wadland, WC., Soffelmayr, B., Ives, K.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04969978

Study Details | NCT04969978 | Electronic Quitline Referral ... This phase IV clinical trial determines the impact of implementing a Quitline electronic (e)Referral system with an enhanced academic detailing implementation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4590019/

Academic Detailing Interventions Improve Tobacco Use ... This study demonstrates the feasibility and potential effectiveness of a low-cost and highly disseminable intervention to improve clinician behavior.

3. ajpmonline.org ajpmonline.org/article/S0749-3797(11)00771-9/fulltext

Fax Referrals, Academic Detailing, and Tobacco Quitline Use The goal of the study was to assess the effectiveness of a clinic-based quitline fax referral program supplemented with enhanced academic detailing (F2Q+EAD) ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379711007719

Fax Referrals, Academic Detailing, and Tobacco Quitline Use The goal of the study was to assess the effectiveness of a clinic-based quitline fax referral program supplemented with enhanced academic detailing (F2Q+EAD) ...

5. withpower.com withpower.com/trial/phase-2022-59689

Enhanced Quitline Support for Smoking Cessation (CONNECT ... This phase IV clinical trial determines the impact of implementing a Quitline electronic (e)Referral system with an enhanced academic detailing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3994822/

Patient-specific academic detailing for smoking cessation To describe and to determine the feasibility of a patient-specific academic detailing (PAD) smoking cessation (SC) program in a primary care setting.

7. umassmed.edu umassmed.edu/globalassets/systems-and-psychosocial-advances-research-center/2021/docs/dmh-coe/presentations/evins-pcori-2021-dmh-coe-conference.pdf

A. Eden Evins PCORI Large Pragmatic Trial To test the effect of academic detailing (AD) to primary care physicians, community health worker (CHW) support to persons with SMI who smoked, or both, on ...

8. cdc.gov cdc.gov/pcd/issues/2023/23_0033.htm

A Safety Net Tobacco Use Cessation Resource: Quitline ... Quitlines are free, accessible evidence-based services that may provide an important resource for people facing barriers to clinical treatment for cessation of ...