Proactive Outreach for Smoking Treatment

Phase 2

Completed

Conditions: Mental Illness
Smoking, Tobacco

Registration Number: NCT04988477

Lead Sponsor: Hennepin Healthcare Research Institute

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. 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 94

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Study 3: Smoking Abstinence	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
Study 1: Perceived Feasibility of Intervention	interview (up to 30 minutes at study visit)	Number of participants who reported the proposed intervention was feasible
Study 1: Perceived Acceptability of Intervention	interview (up to 30 minutes at study visit)	number of participants who agreed the proposed intervention was acceptable.
Studies 2 & 3: Feasibility of Recruitment	baseline	Number of participants recruited (goal for study 2=25; goal for study 3=50)
Studies 2 & 3: Feasibility of Retention	3 months post enrollment	% of participants completing follow-up in studies 2 \& 3
Study 2: Perceived Acceptability of Intervention	3 months post enrollment	Qualitative reports of intervention acceptability from selected patients (N=5) and providers and leaders (N=4)

Secondary Outcome Measures

Name	Time	Method
Study 3: Smoking Abstinence	1 year post baseline	30 day prolonged abstinence (no smoking past 30 days prior to 1 year follow-up)
Study 3: Quit Attempts	1 year post-baseline	Number of 24 hour intentional quit attempts
Study 3: Cigarettes Per Day	12 months post baseline	number of cigarettes smoked per day in study 3

Trial Locations

Locations (1): Hennepin Healthcare Research Institute
🇺🇸
Minneapolis, Minnesota, United States
Hennepin Healthcare Research Institute
🇺🇸Minneapolis, Minnesota, United States