Nudges for Smoking Cessation in Mental Illness

(ISRAISE Trial)

Overseen By Aimee James, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Tobacco treatment

Disqualifiers: Active tobacco treatment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

74 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

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

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults over 18 who are patients at a participating clinic, speak and understand English, and currently smoke more than five cigarettes per day. It's not for those actively using or prescribed smoking cessation medication in the past month.

Inclusion Criteria

Patient of participating clinic

Current smoker, >5 cigarettes per day

Can speak and understand English

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

All patients receive a pre-appointment tobacco treatment needs assessment with patient input as decision support for their care team

1 week

1 visit (in-person)

Treatment

Patients are randomized to either usual care or the 'Nudges to Quit' intervention, with follow-up surveys at 3 and 6 months

6 months

3 visits (in-person)

Follow-up

Participants are monitored for smoking behaviors and treatment engagement after the intervention

6 months

2 visits (in-person)

Treatment Details

Interventions

• Nudges
• Usual Care

Trial Overview 'Nudges to Quit' is being tested as a way to help people with serious mental illness quit smoking by increasing engagement between patients, case workers, and pharmacists. This pilot study will inform a larger future trial.

Participant Groups

Group I: "Nudges to Quit" Experimental Treatment 1 Intervention

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

Group II: Usual Care Active Control 1 Intervention

Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+