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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 40 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. Primary outcome includes patient receipt of tobacco treatment. Secondary outcomes include smoking behaviors such as smoking quantity, readiness to quit, smoking abstinence, and quit attempts.

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

Conditions
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Smoking, Smoking Cessation, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Usual Care
* Behavioral: Nudges


Participation Criteria
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Eligibility Criteria
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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 prescription for smoking cessation medication (within the past 30 days)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized on a 1:1 basis to usual care or intervention 'nudges to quit'.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months. | Behavioral: Usual Care<br>* Usual care will be informed by practice guidelines (patient smoking cessation handout and brief advice).<br>|
| Experimental: Nudges to Quit<br>Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement. | Behavioral: Nudges<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Reported Outcomes, Smoking Cessation, Smoking Behaviors, Nicotine Addiction, Tobacco treatment