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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05952401
Acronym
ISRAISE
Enrollment
59
Registered
2023-07-19
Start date
2024-02-02
Completion date
2025-02-28
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Smoking Cessation, Tobacco Use Cessation

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

BEHAVIORALUsual Care

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

BEHAVIORAL"Nudges"

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

Washington University School of Medicine
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Patients will be randomized on a 1:1 basis to usual care or intervention 'nudges to quit'.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Proportion of Patients Receiving Any Tobacco TreatmentAt 3 monthsThis will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling).

Secondary

MeasureTime frameDescription
Proportion of Patients Receiving Any Tobacco TreatmentAt 6 monthsThis will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling).
Readiness to Quit SmokingAt 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 Abstinence3 months post interventionThis will be quantified by the proportion of smokers with bioverified point prevalence abstinence smoking abstinence at 3 months.
Abstinence Outcomes Across Time PointsAt 3 months and 6 monthsThe 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 PointsAt 3 months and 6 monthsThe 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 AttemptsAt 3 months and 6 monthsThis outcome measure is the number of quit attempts over these time points.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLi-Shiun Chen, M.D., MPH, ScD

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

ArmCount
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
Total59

Baseline characteristics

CharacteristicUsual CareNudges to QuitTotal
Age, Customized
24-40 years
6 Participants10 Participants16 Participants
Age, Customized
41-46 years
11 Participants3 Participants14 Participants
Age, Customized
47-59 years
5 Participants9 Participants14 Participants
Age, Customized
60-72 years
8 Participants7 Participants15 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants27 Participants55 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
16 Participants11 Participants27 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
White
12 Participants14 Participants26 Participants
Region of Enrollment
United States
30 participants29 participants59 participants
Sex: Female, Male
Female
17 Participants14 Participants31 Participants
Sex: Female, Male
Male
13 Participants15 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 29
other
Total, other adverse events
0 / 300 / 29
serious
Total, serious adverse events
0 / 300 / 29

Outcome results

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).

Time frame: At 3 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Usual CareProportion of Patients Receiving Any Tobacco TreatmentReceived treatment18 Participants
Usual CareProportion of Patients Receiving Any Tobacco TreatmentDid not receive treatment12 Participants
Nudges to QuitProportion of Patients Receiving Any Tobacco TreatmentReceived treatment23 Participants
Nudges to QuitProportion of Patients Receiving Any Tobacco TreatmentDid not receive treatment6 Participants
Secondary

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

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).

Time frame: At 6 months

Secondary

Quit Attempts

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

Time frame: At 3 months, 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.

Time frame: At 3 months, 6 months

Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Usual CareSmoking AbstinenceAchieved Smoking Abstinence (<5ppm)0 Participants
Usual CareSmoking AbstinenceSelf-Reported Smoking Abstinence, but did not Achieve Bioverified Smoking Abstinence (<5ppm)3 Participants
Usual CareSmoking AbstinenceDid not Self-Report Smoking Abstinence and did not Achieve Bioverified Smoking Abstinence (<5ppm)22 Participants
Nudges to QuitSmoking AbstinenceAchieved Smoking Abstinence (<5ppm)0 Participants
Nudges to QuitSmoking AbstinenceSelf-Reported Smoking Abstinence, but did not Achieve Bioverified Smoking Abstinence (<5ppm)0 Participants
Nudges to QuitSmoking AbstinenceDid not Self-Report Smoking Abstinence and did not Achieve Bioverified Smoking Abstinence (<5ppm)26 Participants
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.

Time frame: At 3 months, 6 months

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026