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

10000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is Enhanced Quitline Support for Smoking Cessation safe for humans?

The research articles do not provide specific safety data for Enhanced Quitline Support or related interventions like Enhanced Academic Detailing or Informational Support. However, these interventions generally involve counseling and support, which are typically considered safe for humans. ^{1 2 3 4 5}

How is the Enhanced Quitline Support treatment for smoking cessation different from other treatments?

Enhanced Quitline Support is unique because it offers personalized, long-term telephone counseling with the same advisor for each call, and integrates medication support and electronic communication like web and email, making it more accessible and tailored compared to traditional smoking cessation methods. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Enhanced Quitline Support for Smoking Cessation?

Research shows that adding relapse prevention materials to telephone counseling can significantly increase the chances of quitting smoking for those who do not use nicotine patches. Additionally, brief interventions and personalized support in healthcare settings have been effective in helping people quit smoking. ^{9 10 11 12 13}

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

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Multicomponent individualized smoking cessation intervention for patients with lung disease. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of adding relapse prevention materials to telephone counseling. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Quitline Tobacco Interventions in Hospitalized Patients: A Randomized Trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Tobacco cessation interventions in health care settings: rationale, model, outcomes. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Enhancing smoking cessation of low-income smokers in managed care. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Improving the continuity of smoking cessation care delivered by quitline services. [2019]

7. Greece pubmed.ncbi.nlm.nih.gov

Costs to provide a tobacco cessation intervention with parents of pediatric emergency department patients. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Proactive enrollment of parents to tobacco quitlines in pediatric practices is associated with greater quitline use: a cross-sectional study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Prevention of relapse in women who quit smoking during pregnancy. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Parental Smoking Cessation: Impacting Children's Tobacco Smoke Exposure in the Home. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Quitlines a tool for research and dissemination of evidence-based cessation practices. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

A Safety Net Tobacco Use Cessation Resource: Quitline Service Usage, 2019. [2023]

13. Australia pubmed.ncbi.nlm.nih.gov

The potential of quitlines to increase smoking cessation. [2019]