Proactive Outreach for Smoking Treatment (POST)

Implementation of Cessation Treatment in Community Based Mental Health Centers

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.

Study Overview

• Status: Completed
• Conditions: Mental Illness; Smoking, Tobacco
• Intervention / Treatment: Behavioral: Study 3: Chronic care management; Behavioral: Study 2: Pilot trial

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin Healthcare Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Study 3: Chronic care management; Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 9 months.
Experimental: 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.	Behavioral: Study 2: Pilot trial; Providers trained in brief provider intervention and 1 outreach call over 3 months.
No Intervention: Study 1; Patients, providers and leaders at community mental health centers were interviewed about intervention feasibility and acceptability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 3: Smoking Abstinence	30 day prolonged abstinence (no smoking past 30 days prior to 1 year follow-up)	1 year post baseline
Study 3: Quit Attempts	Number of 24 hour intentional quit attempts	1 year post-baseline
Study 3: Cigarettes Per Day	number of cigarettes smoked per day in study 3	12 months post baseline

Collaborators and Investigators

• Sponsor: Sandra Japuntich
• Collaborators: National Institute on Drug Abuse (NIDA); Brown University; University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): January 27, 2023

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: smoking; implementation science; Serious mental illness; Chronic care model
• Additional Relevant MeSH Terms: Behavior; Tobacco Use; Mental Disorders; Smoking; Tobacco Smoking
• Other Study ID Numbers: 19-4723; 5R34DA046078 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Within 18 months of study completion, we will make completely de-identified data (i.e., data that has been cleaned of all 18 types of HIPAA identifiers) datasets available to interested investigators who submit a written request to the PI. The only contingency on the use of the data will be that ethical guidelines be followed (e.g., only individuals who have completed a research ethics training course will have access to the data, the data will be stored securely).
• IPD Sharing Time Frame: 18 months after collection of primary outcome data for 5 years post data collection.
• IPD Sharing Access Criteria: research ethics training
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No