Proactive Outreach for Smoking Treatment

NCT04988477 | Completed Phase 2 Results

• 2 other identifiers: 19-47235R34DA046078
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Tobacco use disorder is a chronic disease. This is particularly true for people living with mental illness, who are more likely to smoke and make more unsuccessful quit attempts than those without. The current study is designed to test a package of two chronic disease management strategies to treatment tobacco in community mental health centers: regular provider interventions during routine mental healthcare visits, and proactive outreach by community mental health center staff to offer connections to tobacco cessation treatment. In study 1 we will interview patients, providers and leaders across wo community healthcare systems, in study 2 we will pilot test the package of interventions in 25 patients at a community mental health center for feasibility and acceptability. in Study 3, 50 patients at a community mental health center will receive provider intervention at their regular visits as well as 3 outreach calls over 9 months from trained staff to offer to connect them with stop smoking treatment. The investigators will measure the effect of these interventions on tobacco use over the next year.

Conditions

Smoking, Tobacco; Mental Illness

Keywords

smoking; Chronic care model; Serious mental illness; implementation science

Outcome Measures

Primary Outcomes (6)

• Study 3: Smoking Abstinence

  number of participants who reported 7-day point prevalence smoking abstinence (no smoking past 7 days) and a expired air CO value of \<6ppm in study 3 only

  1 year post baseline

• Study 1: Perceived Feasibility of Intervention

  Number of participants who reported the proposed intervention was feasible

  interview (up to 30 minutes at study visit)

• Study 1: Perceived Acceptability of Intervention

  number of participants who agreed the proposed intervention was acceptable.

  interview (up to 30 minutes at study visit)

• Studies 2 & 3: Feasibility of Recruitment

  Number of participants recruited (goal for study 2=25; goal for study 3=50)

  baseline

• Studies 2 & 3: Feasibility of Retention

  % of participants completing follow-up in studies 2 \& 3

  3 months post enrollment

• Study 2: Perceived Acceptability of Intervention

  Number of participants who perceived that the intervention was acceptable drawn from qualitative reports of intervention acceptability from selected patients (N=5) and providers and leaders (N=4)

  3 months post enrollment

Secondary Outcomes (3)

• Study 3: Smoking Abstinence

  1 year post baseline

• Study 3: Quit Attempts

  1 year post-baseline

• Study 3: Cigarettes Per Day

  12 months post baseline

Study Arms (3)

Study 3

EXPERIMENTAL

Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.

Behavioral: Study 3: Chronic care management

Study 2

EXPERIMENTAL

In this study, participants received brief provider interventions about tobacco and a single outreach call to connect them to telephone cessation counseling and facilitate obtaining cessation medication.

Behavioral: Study 2: Pilot trial

Study 1

NO INTERVENTION

Patients, providers and leaders at community mental health centers were interviewed about intervention feasibility and acceptability

Interventions

Study 3: Chronic care management BEHAVIORAL

Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 9 months.

Study 3

Study 2: Pilot trial BEHAVIORAL

Providers trained in brief provider intervention and 1 outreach call over 3 months.

Study 2

Eligibility Criteria

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

You may qualify if:

• daily cigarettes smokers (smoking \>25 days/month)
• English speaking
• patient in one of the two community mental health center study sites.

You may not qualify if:

• cognitive impairment
• judged by community mental health center staff as unable to participate in research
• no access to a telephone
• no mailing address.

Sponsors & Collaborators

• Sandra Japuntich: lead
• Brown University: collaborator
• University of Minnesota: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Tobacco Smoking; Mental Disorders; Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Results Point of Contact

• Title: Dr. Sandra Japuntich
• Organization: Hennepin Healthcare Research Institute

sandra.japuntich@hcmed.org

6128736856

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sandra Japuntich, Ph.D., L.P.

Model Details: Study 1 is a key informant interview study. Study 2 is a pre-post study. Study 3: is a pre-post study with multiple baselines to account for change over time.

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 3, 2021
• Study Start: July 14, 2021
• Primary Completion: December 6, 2022
• Study Completion: January 27, 2023
• Last Updated: December 8, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 18 months after collection of primary outcome data for 5 years post data collection.
• Access Criteria: research ethics training

Locations

US (1)