Clinical trial NCT05952401: Implementation Science to Reduce the Disparity in Tobacco Treatment Among Individuals With Serious Mental Illness
Official title: Implementation Science to Reduce the Disparity in Tobacco Treatment Among Individuals With Serious Mental Illness (ISRAISE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Tobacco Use Cessation
Keywords: Patient Reported Outcomes
Smoking Cessation
Smoking Behaviors
Nicotine Addiction
Tobacco treatment
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-07-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized on a 1:1 basis to usual care or intervention 'nudges to quit'.
Primary purpose: PREVENTION

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 increate 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients receiving any tobacco treatment
timeFrame: At 3 months
Secondary outcomes:
measure: Proportion of patients receiving any tobacco treatment
timeFrame: At 6 months
measure: Readiness to quit smoking
timeFrame: At 3 months, 6 months
measure: Smoking abstinence
timeFrame: 3 months post intervention
measure: Abstinence outcomes across multiple time points
timeFrame: At 3 months, 6 months
measure: Smoking quantity across multiple time points
timeFrame: At 3 months, 6 months
measure: Quit attempts
timeFrame: At 3 months, 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Li-Shiun Chen, M.D., MPH, ScD
role: PRINCIPAL_INVESTIGATOR
References: