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

NCT05952401 | Completed Results

• 2 other identifiers: 202307051P50CA244431
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Cessation; Tobacco Use Cessation

Keywords

Patient Reported Outcomes; Smoking Cessation; Smoking Behaviors; Nicotine Addiction; Tobacco treatment

Outcome Measures

Primary Outcomes (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).

  At 3 months

Secondary Outcomes (6)

• Proportion of Patients Receiving Any Tobacco Treatment

  At 6 months

• Readiness to Quit Smoking

  At 3 months and 6 months

• Smoking Abstinence

  3 months post intervention

• Abstinence Outcomes Across Time Points

  At 3 months and 6 months

• Smoking Quantity Across Multiple Time Points

  At 3 months and 6 months

Study Arms (2)

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.

Behavioral: Usual Care

"Nudges to Quit"

EXPERIMENTAL

Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.

Behavioral: "Nudges"

Interventions

Usual Care BEHAVIORAL

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

Usual Care

"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.

"Nudges to Quit"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Li-Shiun Chen, M.D., MPH, ScD
• Organization: Washington University School of Medicine

li-shiun@wustl.edu

314-362-3932

Study Officials

• Li-Shiun Chen, M.D., MPH, ScD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: February 2, 2024
• Primary Completion: December 13, 2024
• Study Completion: February 28, 2025
• Last Updated: March 10, 2026
• Results First Posted: December 16, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)