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SmokingISRAISENCT05952401

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

A study testing "Nudges" in people with Smoking and Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking, Smoking Cessation, Tobacco Use Cessation
What is being tested?
"Nudges"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
2 Feb 2024to 28 Feb 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
Usual Care, "Nudges"
Keywords
Patient Reported Outcomes, Smoking Cessation, Smoking Behaviors, Nicotine Addiction, Tobacco treatment
Medical subject headings
Smoking, Smoking Cessation, Tobacco Use Cessation, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual CareBehavioural

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

  • "Nudges"Behavioural

    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.

Study groups in NCT05952401
Study groupRoleWhat they receive
Usual CareActive comparatorPatients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
Receives: Behavioral: Usual Care
"Nudges to Quit"ExperimentalPatients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
Receives: Behavioral: "Nudges"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At 3 months

Secondary outcomes (6)
  1. 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).

    Measured: At 6 months

  2. 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.
    • 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.

    Measured: At 3 months and 6 months

  3. Smoking Abstinence

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

    Measured: 3 months post intervention

  4. Abstinence Outcomes Across 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.

    Measured: At 3 months and 6 months

  5. 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.

    Measured: At 3 months and 6 months

  6. Quit Attempts

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

    Measured: At 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start2 Feb 2024
  3. Primary completion13 Dec 2024
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized on a 1:1 basis to usual care or intervention 'nudges to quit'.
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05952401
Sponsor's protocol ID
202307051
Other IDs
P50CA244431
Acronym
ISRAISE
Status last verified
Feb 2026
First submitted
11 Jul 2023
Last updated
10 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing "Nudges" in people with Smoking and Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Receiving Any Tobacco Treatment (time frame: At 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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