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Smoking, TobaccoPhase 2POSTNCT04988477

Proactive Outreach for Smoking Treatment

A Phase 2 study testing Study 3: Chronic care management and Study 2: Pilot trial in people with Smoking, Tobacco and Mental Illness, run by Sandra Japuntich at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking, Tobacco, Mental Illness
What is being tested?
Study 3: Chronic care management and Study 2: Pilot trial
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteUnited States
Study dates
14 Jul 2021to 27 Jan 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hennepin Healthcare Research Institute

    Minneapolis, Minnesota, 55415

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Study 3: Chronic care management, Study 2: Pilot trial
Keywords
smoking, Chronic care model, Serious mental illness, implementation science
Medical subject headings
Tobacco Smoking, Mental Disorders, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study 3: Chronic care managementBehavioural

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

  • Study 2: Pilot trialBehavioural

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

Study groups in NCT04988477
Study groupRoleWhat they receive
Study 3ExperimentalQuarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Receives: Behavioral: Study 3: Chronic care management
Study 2ExperimentalIn 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.
Receives: Behavioral: Study 2: Pilot trial
Study 1No interventionPatients, providers and leaders at community mental health centers were interviewed about intervention feasibility and acceptability

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year post baseline

  2. Study 1: Perceived Feasibility of Intervention

    Number of participants who reported the proposed intervention was feasible

    Measured: interview (up to 30 minutes at study visit)

  3. Study 1: Perceived Acceptability of Intervention

    number of participants who agreed the proposed intervention was acceptable.

    Measured: interview (up to 30 minutes at study visit)

  4. Studies 2 & 3: Feasibility of Recruitment

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

    Measured: baseline

  5. Studies 2 & 3: Feasibility of Retention

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

    Measured: 3 months post enrollment

  6. 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)

    Measured: 3 months post enrollment

Secondary outcomes (3)

  1. Study 3: Smoking Abstinence

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

    Measured: 1 year post baseline

  2. Study 3: Quit Attempts

    Number of 24 hour intentional quit attempts

    Measured: 1 year post-baseline

  3. Study 3: Cigarettes Per Day

    number of cigarettes smoked per day in study 3

    Measured: 12 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2021
  2. Study start14 Jul 2021
  3. Primary completion6 Dec 2022
  4. Study completion27 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04988477
Sponsor's protocol ID
19-4723
Other IDs
5R34DA046078
Acronym
POST
Status last verified
May 2025
First submitted
23 Jul 2021
Last updated
8 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Study 3: Chronic care management and Study 2: Pilot trial in people with Smoking, Tobacco and Mental Illness, run by Sandra Japuntich at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study 3: Smoking Abstinence (time frame: 1 year post baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04988477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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