Proactive Outreach for Smoking Treatment

NCT ID: NCT04988477

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2023-01-27

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.

Detailed Description

BACKGROUND: The US Public Health Service (USPHS) designated tobacco dependence as a chronic disease. This is especially true for smokers with serious mental illness (SMI) who make more cessation attempts and are less successful sustaining long-term abstinence than the general population. There is a significant health disparity wherein individuals with SMI have a higher tobacco use prevalence and a greater risk for tobacco-related mortality than the general population. Chronic care models suggest chronic disease management requires a multidisciplinary care team to assess tobacco use, administer treatment, support patient self-management, and monitor progress. Proactive telephone outreach to smokers and brief provider interventions are two effective chronic disease management strategies. Community based mental health centers (CMHCs) are a primary treatment access point for many smokers with SMI. However, rates of intervention with smoking by CMHC providers are low. In order to implement the chronic care model for tobacco dependence for CMHCs, comprehensive implementation strategies are needed. OBJECTIVE: to conduct a feasibility pilot trial to adapt an implementation strategy developed by the SAMHSA-funded network of Addiction Technology Transfer Centers (ATTCs) to integrate a proactive, chronic care model of tobacco cessation treatment into CMHCs. AIM: To conduct a pilot trial to assess the feasibility, acceptability and initial effectiveness of the implementation strategy. DESIGN: The investigators will conduct 3 studies. The first study will include qualitative interviews of 29 individuals including patients, providers and leaders. Study 2 will be a pilot test of the study intervention. 25 patients will receive the intervention for 3 months the primary outcome is feasibility and acceptability as measured 3 months post intervention. Study 3 is a pilot hybrid type 2 implementation-effectiveness trial in 3 CMHCs (N=50 patients; 96-130 providers). The investigators will conduct 2 baseline assessments (3 months apart) and outcomes will be assessed at 3, 6, and 12-months post implementation.

Outcomes include feasibility, acceptability, effectiveness of the implementation strategy on tobacco cessation treatment utilization (counseling and medication) and patient effectiveness on tobacco cessation (CO confirmed 7-day point prevalence abstinence). SIGNIFICANCE: An effective implementation strategy for tobacco cessation treatment in CMHCs, a widespread model of care delivery, would have enormous public health impact.

Conditions

Smoking, Tobacco; Mental Illness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study 3

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

Group Type: EXPERIMENTAL

Study 3: Chronic care management

Intervention Type: BEHAVIORAL

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

Study 2

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.

Group Type: EXPERIMENTAL

Study 2: Pilot trial

Intervention Type: BEHAVIORAL

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

Study 1

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Study 3: Chronic care management

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

Intervention Type: BEHAVIORAL

Study 2: Pilot trial

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Sandra Japuntich

OTHER

Sponsor Role: lead

Responsible Party

Sandra Japuntich

Sandra Japuntich, Ph.D., L.P.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R34DA046078

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-4723

Identifier Type: -

Identifier Source: org_study_id