Testing an Organizational Change Model to Address Smoking in Mental Healthcare
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000,
      the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times
      greater than in the general population. Further, even the recent small decline in smoking
      rates that has been reported in the general population in the past decade has not occurred
      among smokers with an SMI. In fact, 44% of all the cigarettes consumed in the US are by
      individuals with a psychiatric disorder and the primary cause of death among Americans with
      an SMI is a tobacco-related disease.

      This cluster randomized trial will be conducted in 14 Philadelphia community mental health
      clinics (CMHCs). Clinics will be randomized to either Addressing Tobacco Through
      Organizational Change model (ATTOC) or Usual Care (UC) treatment groups. The investigators
      hypothesize that 1) at the end of the intervention and at a 3-month follow-up, rates of
      adherence to guidelines for treating TUD will be greater among clinic personnel that receive
      the ATTOC intervention vs. clinic personnel in usual care; 2) at the end of the intervention
      and at a 3-month follow-up, rates of client smoking cessation will be significantly greater
      in clinics that receive the ATTOC intervention than among clients treated with usual care;
      and 3) using non-inferiority testing, at the end of the intervention and at a 3-month
      follow-up, there will be no significant degradation in mental health functioning or QOL among
      clients who receive care at clinics that received the ATTOC intervention than among clients
      treated with usual care.
    

Detailed description: 
      Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000,
      the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times
      greater than in the general population. Transforming the mental healthcare system to
      integrate and adhere to evidence-based guidelines for the provision of tobacco use disorder
      (TUD) treatment is a priority of the National Institute of Mental Health and is a critical
      component of a national effort to meet Healthy People 2020 target goals for tobacco use
      (www.healthypeople.gov).

      The Addressing Tobacco Through Organizational Change (ATTOC) model is a systems-level
      intervention to address systemic and cultural barriers that undermine assessment and
      treatment of TUD. In this innovative way, ATTOC assumes that effective organizational change
      requires more than clinic personnel training; it also requires the application of
      organizational theory to address attitudinal and system barriers and promote a culture in
      which tobacco use is not accepted or supported and that TUD treatment is integrated into
      standard practice. Consistent with organizational theory, ATTOC is implemented in 3 phases:
      preparing for, implementing, and sustaining change. By addressing cultural barriers and
      strengthening the care system (e.g., integrated treatment), ATTOC intends to have sustained
      benefits beyond the intervention.

      This cluster-randomized trial will be conducted with 14 Philadelphia CMHCs, 7 randomized to
      ATTOC and 7 to usual care (UC). Following randomization, study staff will visit sites to
      recruit clinic personnel and clients over a 4 to 6 week period. Those eligible will complete
      informed consent and HIPAA forms and a baseline assessment to establish pre-intervention
      levels on all measures (baseline). After 4-6 weeks, the ATTOC intervention will be
      implemented over 9 months, from Week 1 to Week 36 (with UC at the control sites). Two
      mid-intervention assessments (Weeks 12 and 24) will allow for performance feedback and
      mediational analyses. Week 36 (end-of-treatment; EOT) and 52 (3-months post-EOT) assessments
      will allow for evaluation of changes on outcomes between groups over time. All measures will
      be conducted at the respective CMHC (or over the phone if necessary) and 7-day point
      prevalence smoking cessation will be verified using a breath carbon monoxide (CO) monitor
      (abstinence = < 8ppm).

      This will be the first controlled, randomized trial to evaluate the effects of the ATTOC
      model on clinician adherence to treatment guidelines, client smoking, and client mental
      health and QOL. If this approach is shown to be effective and safe, it can serve as a model
      for the nation's community mental healthcare infrastructure, representing a powerful
      initiative to address tobacco use in an under-served sub-group of smokers, and support
      efforts to attain the Healthy People 2020 goals regarding tobacco use.
    

Intervention name(s): ATTOC Intervention; UC Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.; Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Smoking cessation; Nicotine dependence; Organizational change; Mental Healthcare