Clinical trial NCT02845440: Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness
Official title: Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Schizophrenia
Bipolar Disorder
Depressive Disorder, Major
Smoking Cessation
Keywords: Pragmatic Trial
Community Health Workers
Academic Detailing
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Bay Cove Human Services
name: Brigham and Women's Hospital
name: University of Massachusetts, Amherst
name: Vinfen
First posted: 2016-07-27
Enrollment: 1165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of this study is to test the effect of academic detailing (i.e. provider-level educational intervention focused on evidence-based smoking cessation treatment for those with psychiatric illness) and community health worker (CHW) support on the provision and utilization of standard of care smoking cessation treatment to those with serious mental illness (SMI) and smoking cessation rates for adults with SMI who smoke.

Detailed 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 psychiatric illness, termed academic detailing (AD), and 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 enroll 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. Primary care clinics that serve 3 or more enrolled participants will be cluster randomized in a 2:1 ratio to either receive AD for their clinical staff or treatment as usual (TAU) in a cluster randomized design. Smokers with SMI in the study who receive primary care at the clinics assigned to the AD intervention to providers will be randomly assigned at the individual level in a 1:1 ratio to be offered CHW support in addition to their ongoing psychiatric rehabilitation (CBFS or ACT) services. This was the original design for the study and these participants comprise Cohort 1. The protocol was modified and approved by the sponsor in February 2018 to include a second cohort. Because 155 enrolled participants received primary care in 155 clinics that served only 1-2 participants, and it was beyond the scope of the trial to deliver AD to so many clinics, a second cohort was formed in which these 155 participants were randomly assigned at the individual level in a 1:1 ratio to CHW or TAU.

This study was also modified by receipt of a qualitative supplement award from the sponsor to conduct 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.

Eligibility criteria: Inclusion:

* adult (18+ years)
* current smoker
* current diagnosis of SMI (e.g. schizophrenia, bipolar disorder, major depressive disorder, etc...)
* currently receiving psychiatric rehabilitation services through CBFS and ACT programs at Bay Cove Human Services and Vinfen Corporation

Exclusion:

* intellectual disability (IQ\<70)

Primary outcomes:
measure: Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1
timeFrame: Assessment at end of year 2 of intervention
Secondary outcomes:
measure: Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1
timeFrame: Any use over assessments for years 1 or 2 of intervention
measure: Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1
timeFrame: Any use over assessments for years 1 or 2 of intervention
measure: Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1
timeFrame: Assessment at end of year 2 of intervention
measure: Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1
timeFrame: Assessment at end of year 2 of intervention
measure: Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2
timeFrame: Assessment at end of year 2 of intervention
measure: Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohorts 1 and 2
timeFrame: Any use over assessments for years 1 or 2 of intervention
measure: Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2
timeFrame: Any use over assessments for years 1 or 2 of intervention
measure: Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2
timeFrame: Assessment at end of year 2 of intervention
measure: Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2
timeFrame: Assessment at end of year 2 of intervention
measure: Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1
timeFrame: Assessment at end of year 2 of intervention
measure: Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2
timeFrame: Assessment at end of year 2 of intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: A Eden Evins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: