Implementation Science to Reduce the Disparity in Tobacco Treatment Among Individuals With Serious Mental Illness

Smoking Cessation Clinical Trial

— ISRAISE  

Official title:

Implementation Science to Reduce the Disparity in Tobacco Treatment Among Individuals With Serious Mental Illness (ISRAISE)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05952401
• Other study ID #: 202307051
• Secondary ID: P50CA244431
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot trial to examine the feasibility and preliminary effect of a multilevel intervention 'Nudges to Quit' on smoking cessation in patients with serious mental illness who smoke in a community mental health center (CMHC). "Nudges to Quit" is a multilevel intervention to increate engagement of patient, case worker, and pharmacist with tobacco treatment. The pilot trial is to generate the needed evidence for designing a future large trial to evaluate the effect of 'Nudges to Quit' as a multilevel intervention to increase tobacco treatment and reduce tobacco use among patients with serious mental illness.

Description:

The overarching goal of this pilot project is to reduce the disparity in the treatment of tobacco use among individuals with serious mental illness (SMI) with low burden, multi-level implementation strategies, an important need reflected in existing evidence and a recent survey of community needs. Individuals with SMI have a much higher smoking prevalence (60% vs. 15%) and die 25 years earlier compared to the general population. Despite the fact that SMI patients express interest in and have success with evidence-based smoking cessation treatment, inadequate provision of treatment in community mental health centers (CMHCs) contributes to the high smoking prevalence and related health consequences among the mentally ill. The pilot trial aims to understand the feasibility and preliminary effects of a multilevel intervention "Nudges to Quit," designed to increase patient, case worker, and pharmacist engagement with tobacco treatment in a community mental health clinic setting. Therefore, the investigators propose a pilot randomized trial of 60 patients. Patients will be randomized with 1:1 allocation to usual care vs. intervention "Nudges to Quit". All patients will receive pre-appointment tobacco treatment needs assessment (t1) with patient input as decision support for their care team. For patients in the intervention arm, their care team (case worker and pharmacist) will receive nudge reminders based on patient-reported tobacco treatment need assessment to offer tobacco treatment. For patients in the usual care arm, the team will proceed with usual care and receive the intervention at 3 months post-enrollment (t2) to ensure all participants will receive benefit from the intervention with variation in timing. All patients will receive a baseline (t1), 3 month (t2), and 6 month follow-up survey (t3). In Aim 1, the investigators will test the effect of nudges on patient receipt of tobacco treatment. The investigators hypothesize patient receipt of tobacco cessation treatment such as medication and counseling will be higher after delivery of nudges over usual care. In Aim 2, the investigators will test the effect of nudges on smoking behaviors. The investigators hypothesize smoking behaviors will be positively effected in the nudges to quit group compared to usual care. In Aim 3, the investigators will evaluate the feasibility and preliminary effect of this pilot project for a future R01 proposal to systematically evaluate this multilevel intervention adapted for CMHCs.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient of participating clinic
• Current smoker, >5 cigarettes per day
• Age 18 years or older
• Can speak and understand English

Exclusion Criteria:

• Active use or receipt of tobacco treatment (medication or counseling) within the past 30 days

Related Conditions & MeSH terms

• Mental Disorders
• Smoking
• Smoking Cessation
• Tobacco Use Cessation

Intervention

Behavioral:
• Usual Care
Usual care will be informed by practice guidelines (patient smoking cessation handout and brief advice).
• "Nudges"
Patients in the experimental arm will receive practice guidelines (patient smoking cessation handout and brief advice) and "Nudges to Quit", guideline-informed messages immediately following patient tobacco treatment needs assessment.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients receiving any tobacco treatment	This will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling).	At 3 months
Secondary	Proportion of patients receiving any tobacco treatment	This will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling).	At 6 months
Secondary	Readiness to quit smoking	This will be quantified by the proportion of current smokers in the stage of change classifications of Precontemplation, Contemplation, Preparation, or Action.	At 3 months, 6 months
Secondary	Smoking abstinence	This will be quantified by the proportion of smokers with bioverified point prevalence abstinence smoking abstinence at 3 months.	3 months post intervention
Secondary	Abstinence outcomes across multiple time points	The outcome measure is abstinence (self-reported no smoking (not even a puff of a cigarette) for at least seven days prior to the assessment) over these time points.	At 3 months, 6 months
Secondary	Smoking quantity across multiple time points	The outcome measure is smoking quantity (self-reported average cigarettes smoked per day for the past 30 days prior to the assessment) over these time points.	At 3 months, 6 months
Secondary	Quit attempts	This outcome measure is the number of quit attempts in the past 30 days prior to the assessment over these time points.	At 3 months, 6 months

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine