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Completed

NCT Number: NCT04988477

Proactive Outreach for Smoking Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Study 3: Chronic care management

Behavioral

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

Study 2: Pilot trial

Behavioral

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

Primary outcomes

  1. Study 3: Smoking Abstinence

    Time frame: 1 year post baseline

    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

  2. Study 1: Perceived Feasibility of Intervention

    Time frame: interview (up to 30 minutes at study visit)

    Number of participants who reported the proposed intervention was feasible

  3. Study 1: Perceived Acceptability of Intervention

    Time frame: interview (up to 30 minutes at study visit)

    number of participants who agreed the proposed intervention was acceptable.

  4. Studies 2 & 3: Feasibility of Recruitment

    Time frame: baseline

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

  5. Studies 2 & 3: Feasibility of Retention

    Time frame: 3 months post enrollment

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

  6. Study 2: Perceived Acceptability of Intervention

    Time frame: 3 months post enrollment

    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)

Secondary outcomes

  1. Study 3: Smoking Abstinence

    Time frame: 1 year post baseline

    30 day prolonged abstinence (no smoking past 30 days prior to 1 year follow-up)

  2. Study 3: Quit Attempts

    Time frame: 1 year post-baseline

    Number of 24 hour intentional quit attempts

  3. Study 3: Cigarettes Per Day

    Time frame: 12 months post baseline

    number of cigarettes smoked per day in study 3

Sponsors and collaborators

Lead sponsor

Sandra Japuntich

Other

Collaborators

  • Brown University
  • National Institute on Drug Abuse (NIDA)
  • University of Minnesota

Registry information

Official study title

Implementation of Cessation Treatment in Community Based Mental Health Centers

Acronym: POST

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 3, 2021
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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