POST: Proactive Outreach for Smoking Treatment

Sponsor
Hennepin Healthcare Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04988477
Collaborator
Brown University (Other), University of Minnesota (Other)
50
1
1
17.6
2.8

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Chronic care management
Phase 3

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 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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a pre-post study with multiple baselines to account for change over time.This is a pre-post study with multiple baselines to account for change over time.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implementation of Cessation Treatment in Community Based Mental Health Centers
Actual Study Start Date :
Jul 14, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chronic care for tobacco use

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: Chronic care management
Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.

Outcome Measures

Primary Outcome Measures

  1. Smoking abstinence [12-months post baseline]

    CO validated 7-day point prevalence smoking abstinence

Secondary Outcome Measures

  1. Smoking abstinence [12 months post-baseline]

    30 day prolonged abstinence

  2. Quit attempts [12 months post-baseline]

    Number of 24 hour intentional quit attempts

  3. Cigarettes per day [12 months post baseline]

    number of cigarettes smoked per day

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hennepin Healthcare Research Institute Minneapolis Minnesota United States 55415

Sponsors and Collaborators

  • Hennepin Healthcare Research Institute
  • Brown University
  • University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier:
NCT04988477
Other Study ID Numbers:
  • 19-4723
First Posted:
Aug 3, 2021
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hennepin Healthcare Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022