Smoking, Smoking Cessation, Tobacco Use Cessation
Conditions
Keywords
Patient Reported Outcomes, Smoking Cessation, Smoking Behaviors, Nicotine Addiction, Tobacco treatment
Brief 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 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.
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.
Interventions
Usual care will be informed by practice guidelines (patient smoking cessation handout and brief advice).
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.
Sponsors
Study design
Intervention model description
Patients will be randomized on a 1:1 basis to usual care or intervention 'nudges to quit'.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Receiving Any Tobacco Treatment | At 3 months | This will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Receiving Any Tobacco Treatment | At 6 months | This will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling). |
| Readiness to Quit Smoking | 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. |
| Smoking Abstinence | 3 months post intervention | This will be quantified by the proportion of smokers with bioverified point prevalence abstinence smoking abstinence at 3 months. |
| Abstinence Outcomes Across Time Points | 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. |
| Smoking Quantity Across Multiple Time Points | 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. |
| Quit Attempts | At 3 months and 6 months | This outcome measure is the number of quit attempts over these time points. |
Countries
United States
Contacts
Washington University School of Medicine
Participant flow
Recruitment details
The study opened to participant enrollment on 02/02/2024 and closed to participant enrollment on 09/27/2024.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months. | 30 |
| Nudges to Quit Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement. | 29 |
| Total | 59 |
Baseline characteristics
| Characteristic | Usual Care | Nudges to Quit | Total |
|---|---|---|---|
| Age, Customized 24-40 years | 6 Participants | 10 Participants | 16 Participants |
| Age, Customized 41-46 years | 11 Participants | 3 Participants | 14 Participants |
| Age, Customized 47-59 years | 5 Participants | 9 Participants | 14 Participants |
| Age, Customized 60-72 years | 8 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 27 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 11 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 14 Participants | 26 Participants |
| Region of Enrollment United States | 30 participants | 29 participants | 59 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 31 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 29 |
| other Total, other adverse events | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
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).
Time frame: At 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Proportion of Patients Receiving Any Tobacco Treatment | Received treatment | 18 Participants |
| Usual Care | Proportion of Patients Receiving Any Tobacco Treatment | Did not receive treatment | 12 Participants |
| Nudges to Quit | Proportion of Patients Receiving Any Tobacco Treatment | Received treatment | 23 Participants |
| Nudges to Quit | Proportion of Patients Receiving Any Tobacco Treatment | Did not receive treatment | 6 Participants |
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.
Time frame: At 3 months, 6 months
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).
Time frame: At 6 months
Quit Attempts
This outcome measure is the number of quit attempts over these time points.
Time frame: At 3 months, 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.
Time frame: 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.
Time frame: 3 months post intervention
Population: 5 participants from the Usual Care arm and 3 participants from the Nudges to Quit arm are not included because the participants did not complete the 3-month assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Smoking Abstinence | Achieved Smoking Abstinence (<5ppm) | 0 Participants |
| Usual Care | Smoking Abstinence | Self-Reported Smoking Abstinence, but did not Achieve Bioverified Smoking Abstinence (<5ppm) | 3 Participants |
| Usual Care | Smoking Abstinence | Did not Self-Report Smoking Abstinence and did not Achieve Bioverified Smoking Abstinence (<5ppm) | 22 Participants |
| Nudges to Quit | Smoking Abstinence | Achieved Smoking Abstinence (<5ppm) | 0 Participants |
| Nudges to Quit | Smoking Abstinence | Self-Reported Smoking Abstinence, but did not Achieve Bioverified Smoking Abstinence (<5ppm) | 0 Participants |
| Nudges to Quit | Smoking Abstinence | Did not Self-Report Smoking Abstinence and did not Achieve Bioverified Smoking Abstinence (<5ppm) | 26 Participants |
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.
Time frame: At 3 months, 6 months