Proactive Outreach for Smoking Treatment

Mental Illness Clinical Trial

— POST  

Official title:

Implementation of Cessation Treatment in Community Based Mental Health Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988477
• Other study ID #: 19-4723
• Status: Completed
• Phase: Phase 3
• Start date: July 14, 2021
• Est. completion date: January 27, 2023

Study information

• Verified date: April 2023
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 27, 2023
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness
• Smoking, Tobacco

Intervention

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

Locations

Country	Name	City	State
United States	Hennepin Healthcare Research Institute	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	Brown University, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence	CO validated 7-day point prevalence smoking abstinence	12-months post baseline
Secondary	Smoking abstinence	30 day prolonged abstinence	12 months post-baseline
Secondary	Quit attempts	Number of 24 hour intentional quit attempts	12 months post-baseline
Secondary	Cigarettes per day	number of cigarettes smoked per day	12 months post baseline