Facilitation Strategy for Tobacco Use Disorder

(FITT Trial)

CN
CY
Overseen ByCynthia Y Giron-Hernandez
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans with serious mental illness who smoke quit by increasing the frequency of tobacco cessation medication prescriptions by doctors. Veterans with mental illness smoke at higher rates and face greater health risks. The trial will test a "multi-component facilitation strategy" to encourage mental health providers to offer these medications more often. Veterans who have recently visited specific mental health clinics, have a serious mental illness, and currently smoke might be a good fit. As an unphased trial, this study offers Veterans the opportunity to contribute to important research that could improve healthcare practices.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but if you are already taking bupropion, varenicline, or any nicotine replacement therapy, you cannot participate.

What prior data suggests that this facilitation strategy is safe for Veterans with serious mental illness?

Previous studies have shown promising results when using multiple methods to help people quit smoking. Research indicates that these approaches can assist more individuals in stopping smoking compared to simpler methods. For instance, one study found that 40.4% of participants quit smoking after using a multi-method approach.

These methods often include activities such as educational sessions, feedback on progress, and training. They have been shown to not only aid in quitting smoking but also improve attitudes and beliefs about smoking.

Regarding safety, these multi-method strategies primarily focus on providing support and guidance, making them manageable for participants. Available research reports no specific negative effects linked to these methods, suggesting they are safe for participants, especially since they do not involve new medications or invasive procedures.12345

Why are researchers excited about this trial?

Researchers are excited about the multi-component facilitation strategy for tobacco use disorder because it offers a comprehensive approach that addresses multiple aspects of quitting smoking. Unlike traditional treatments that focus solely on medication or counseling, this strategy includes external facilitation to enhance educational outreach, performance auditing, training, and veteran outreach. By incorporating a team-based approach with dedicated champions and regular implementation meetings, it aims to create a more supportive and personalized environment for individuals attempting to quit smoking. This could potentially lead to higher success rates and a more sustainable path to quitting tobacco.

What evidence suggests that this facilitation strategy is effective for tobacco use disorder?

Research has shown that combining several methods can significantly aid smoking cessation. In this trial, participants will receive a multi-component external facilitation strategy. This involves an external facilitator supporting various activities, such as educational outreach, auditing performance, and providing feedback. One study found that these combined approaches increased the number of people who remained smoke-free for at least seven days. Another study demonstrated that using multiple methods led to higher quit rates at both six months and a year later. Additionally, digital tools and apps improved quitting rates by 56% compared to usual methods. These findings suggest that combining different strategies can effectively help people quit smoking, particularly those who struggle to stop.26789

Who Is on the Research Team?

CN

Corinne N Kacmarek, PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

This trial is for Veterans with serious mental illness who currently smoke and have had recent or upcoming appointments at VA Maryland mental health clinics. It also involves their healthcare providers. Veterans already using certain quit-smoking medications can't join.

Inclusion Criteria

Providers: VA Maryland Health Care System patient care providers serving Veterans in Critical Time Intervention, Psychosocial Rehabilitation and Recovery Center, Mental Health Integrative Case Management, or outpatient psychiatry clinics
Veterans receiving direct letters: Had an appointment in VA Maryland Health Care System, Critical Time Intervention, Psychosocial Rehabilitation and Recovery Center, Mental Health Integrative Case Management, or outpatient psychiatry clinics in the last 30 days
Veterans receiving direct letters: Diagnosed with a serious mental illness
See 3 more

Exclusion Criteria

I am currently prescribed medication or therapy to help me quit smoking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

External facilitation strategy is implemented to improve tobacco treatment delivery in VA SMI clinics

12 months
Weekly implementation activities

Follow-up

Participants are monitored for changes in tobacco use and prescription rates

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Multi-component facilitation

Trial Overview

The study is testing a multi-part support strategy to help mental health providers offer more tobacco-cessation medications to Veterans with serious mental illness in VA clinics. The goal is to improve how often these treatments are prescribed.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Multi-component external facilitationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

A Randomized Trial of a Multicomponent Cessation Strategy ...

In Table 2, main results for the study are shown. Both groups showed substantial improvement in the proportion of subjects reporting seven-day abstinence at ...

a systematic review and meta-analysis

Meta-analysis revealed that both the 6-month and 12-month outcome timepoints, multicomponent interventions were successful in achieving higher smoking quit ...

Efficacy of digital interventions for smoking cessation by ...

Multicomponent and app-based interventions also significantly improved cessation rates, with RRs of 1.56 (95% CI 1.32–1.84; low-quality evidence) ...

Multicomponent Workplace Tobacco Cessation Interventions

40.4% of the employees were able to quit smoking. Attitudes and cognitions related to smoking also improved. There was a reduction in both ...

A Review of Smoking Cessation Interventions: Efficacy ... - PMC

Moreover, attempting to quit smoking without any structured approach yielded a mere 3%-5% success rate within the same timeframe [7]. This study ...

Personalised multicomponent interventions for tobacco ... - PMC

There was evidence to suggest that multicomponent interventions were more successful in achieving smoking cessation than controls, and there was ...

The Whole Package: A Multi-Component Smoking Cessation ...

Our smoking cessation intervention included: (a) group-based physical activity (PA) game intervention (50 minutes, 3X/week for 12 weeks), (b) pharmacotherapy.

What Are the Effective Components of Group-Based ...

Implementing group-based smoking cessation programs, that incorporate multiple BCTs, is recommended for an effective smoking cessation care.

a protocol study | BMC Public Health | Springer Nature Link

The primary objective is to compare the effectiveness of EMPACT-Us versus newly enhanced usual care (EUC). EMPACT-Us utilizes proactive ...