Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bipolar Disorder
  • Cigarette Smoking
  • Depressive Disorder, Major
  • Schizophrenia
  • Smoking Cessation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

In this study, the investigators aim to test whether a provider-level educational intervention in the form of targeted, practical, action-oriented education to primary care physicians and nurses on safety and effectiveness of and how to use evidence-based smoking cessation treatment for those with p...

In this study, the investigators aim to test whether a provider-level educational intervention in the form of targeted, practical, action-oriented education to primary care physicians and nurses on safety and effectiveness of and how to use evidence-based smoking cessation treatment for those with psychiatric illness, termed academic detailing (AD), alone or in combination with practical support offered to the primary care physician / primary care team and the smoker with SMI in the form of a community health worker (CHW) will improve recommendation and utilization of standard of care smoking cessation treatments to and by those with SMI and, if so, whether the intervention improves smoking cessation rates for adults with SMI who smoke. To do so, the investigators will randomize primary care clinics that serve approximately 1300 adult smokers with SMI who receive psychiatric rehabilitation services, Community Based Flexible Support (CBFS) or Assertive Community Treatment (ACT)), from the two largest providers of these services in the Boston area to either receive AD for their prescribers or not in a cluster randomized design. Half of the smokers with SMI in the study who receive primary care at the clinics assigned to the AD intervention to providers will be randomly assigned to be offered CHW support in addition to their ongoing psychiatric rehabilitation (CBFS or ACT) services. This study will also utilize mixed methods research to identify and define barriers and facilitators to implementation of components of the integrated care intervention in primary care clinical settings using an interactive convergent mixed-methods design. The aim of this portion of the study is to better understand the factors that impact the integration of Integrated Care and evidence-based treatments for smoking cessation for those with SMI in primary care settings. Qualitative interviews will be conducted for enrolled participants, CHWs, primary care physician, and stakeholders.

Tracking Information

NCT #
NCT02845440
Collaborators
  • Bay Cove Human Services
  • Brigham and Women's Hospital
  • University of Massachusetts, Amherst
  • Vinfen
Investigators
Principal Investigator: A Eden Evins, MD, MPH Massachusetts General Hospital