Clinical trial NCT04988477: Proactive Outreach for Smoking Treatment
Official title: Implementation of Cessation Treatment in Community Based Mental Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking, Tobacco
Mental Illness
Keywords: smoking
Chronic care model
Serious mental illness
implementation science
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Brown University
name: University of Minnesota
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-08-03
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study 3: Smoking Abstinence
timeFrame: 1 year post baseline
measure: Study 1: Perceived Feasibility of Intervention
timeFrame: interview (up to 30 minutes at study visit)
measure: Study 1: Perceived Acceptability of Intervention
timeFrame: interview (up to 30 minutes at study visit)
measure: Studies 2 & 3: Feasibility of Recruitment
timeFrame: baseline
measure: Studies 2 & 3: Feasibility of Retention
timeFrame: 3 months post enrollment
measure: Study 2: Perceived Acceptability of Intervention
timeFrame: 3 months post enrollment
Secondary outcomes:
measure: Study 3: Smoking Abstinence
timeFrame: 1 year post baseline
measure: Study 3: Quit Attempts
timeFrame: 1 year post-baseline
measure: Study 3: Cigarettes Per Day
timeFrame: 12 months post baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute
state: Minnesota
Study officials:
References: