NCT04988477|CompletedPhase 2Results
Proactive Outreach for Smoking Treatment
POST
Implementation of Cessation Treatment in Community Based Mental Health Centers
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Sponsor study identifier
Secondary identifiers
NIH
interventional
94
1 country
1
Study Start
July 14, 2021
Actual (reported)Primary Completion
December 6, 2022
Actual (reported)Study Completion
January 27, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 27, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 14, 2021
Actual (reported)July 23, 2021
Actual (reported)August 3, 2021
Actual (reported)December 6, 2022
Actual (reported)January 27, 2023
Actual (reported)May 28, 2025
Actual (reported)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
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
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
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.
Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 9 months.
Providers trained in brief provider intervention and 1 outreach call over 3 months.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415, United States
94 participants (actual enrollment reported by the registry).
First Submitted
July 23, 2021
First Posted
August 3, 2021
Study Start
July 14, 2021
Laboratory Screening of Lorcaserin for Alcohol Use Disorder
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
Patients, providers and leaders at community mental health centers were interviewed about intervention feasibility and acceptability
Contact the study team to confirm eligibility.
Primary Completion
December 6, 2022
Actual (reported)Study Completion
January 27, 2023
Actual (reported)Last Updated
December 8, 2025
Results First Posted
May 28, 2025
Record last verified: 2025-05
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).
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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