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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA244431 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months. |
|
| "Nudges to Quit" | Experimental | Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Behavioral | Usual care will be informed by practice guidelines (patient smoking cessation handout and brief advice). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li-Shiun Chen, M.D., MPH, ScD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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The study consented 73 participants and 14 were excluded after consenting due to loss of contact or not meeting all eligibility criteria prior to randomization. 59 were considered enrolled and 14 were not considered enrolled in the study per the policy of the institution.
The study opened to participant enrollment on 02/02/2024 and closed to participant enrollment on 09/27/2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months. |
| FG001 | "Nudges to Quit" | Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months. |
| BG001 | "Nudges to Quit" |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | At 3 months |
|
6 months (07/01/2024 - 12/31/2024)
As part of this study, no participants experienced all-cause mortality or any serious adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Li-Shiun Chen, M.D., MPH, ScD | Washington University School of Medicine | 314-362-3932 | li-shiun@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2023 | Dec 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2025 | Dec 1, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D020340 | Tobacco Use Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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Patients will be randomized on a 1:1 basis to usual care or intervention 'nudges to quit'.
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| "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. |
|
- 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 and 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 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 and 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 and 6 months |
| Quit Attempts | This outcome measure is the number of quit attempts over these time points. | At 3 months and 6 months |
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| 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). | Posted | Count of Participants | Participants | 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.
| The participants are not included in the number analyzed if the participants missed responding at the specified time point. | Posted | Count of Participants | Participants | At 3 months and 6 months |
|
|
|
| Secondary | Smoking Abstinence | This will be quantified by the proportion of smokers with bioverified point prevalence abstinence smoking abstinence at 3 months. | Posted | Count of Participants | Participants | 3 months post intervention |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At 3 months and 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. | The participants are not included in the number analyzed if the participants missed responding at the specified time point. | Posted | Mean | Standard Error | cigarettes per day | At 3 months and 6 months |
|
|
|
| Secondary | Quit Attempts | This outcome measure is the number of quit attempts over these time points. | The participants are not included in the number analyzed if the participants missed responding at the specified time point. | Posted | Mean | Standard Error | quit attempts | At 3 months and 6 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | "Nudges to Quit" | Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D001523 |
| Mental Disorders |
| Contemplation Stage |
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| Preparation Stage |
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| Action Stage |
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| 6 months |
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| Did not Self-Report Smoking Abstinence and did not Achieve Bioverified Smoking Abstinence (<5ppm) |
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| 6 months |
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| 6 months |
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| 6 months |
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