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Completed

NCT Number: NCT05952401

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

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 increase 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Behavioral

Usual care will be informed by practice guidelines (patient smoking cessation handout and brief advice).

"Nudges"

Behavioral

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.

Primary outcomes

  1. Proportion of Patients Receiving Any Tobacco Treatment

    Time frame: At 3 months

    This will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling).

Secondary outcomes

  1. Proportion of Patients Receiving Any Tobacco Treatment

    Time frame: At 6 months

    This will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling).

  2. Readiness to Quit Smoking

    Time frame: At 3 months and 6 months

    • This will be quantified by the proportion of current smokers in the stage of change classifications of Precontemplation, Contemplation, Preparation, or Action.
    • Precontemplation Stage: The participant is not seriously considering quitting within the next 6 months.
    • Contemplation Stage: The participant is seriously considering quitting within the next 6 months.
    • Preparation Stage: The participant is planning to quit within the next 30 days.
    • Action Stage: The participant quit smoking within the last 6 months or quit smoking more than 6 months.
  3. Smoking Abstinence

    Time frame: 3 months post intervention

    This will be quantified by the proportion of smokers with bioverified point prevalence abstinence smoking abstinence at 3 months.

  4. Abstinence Outcomes Across Time Points

    Time frame: At 3 months and 6 months

    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.

  5. Smoking Quantity Across Multiple Time Points

    Time frame: At 3 months and 6 months

    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.

  6. Quit Attempts

    Time frame: At 3 months and 6 months

    This outcome measure is the number of quit attempts over these time points.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: ISRAISE

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 19, 2023
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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