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Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02845440
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : September 4, 2020
Sponsor:
Collaborators:
Bay Cove Human Services
Brigham and Women's Hospital
University of Massachusetts, Amherst
Vinfen
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital

Study Description
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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), alone or in combination with practical support from a community health worker, on the provision and utilization of standard of care smoking cessation treatment to those with serious mental illness (SMI). Further, this study will determine if these interventions improve smoking cessation rates for adults with SMI who smoke.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Schizophrenia Bipolar Disorder Depressive Disorder, Major Smoking Cessation Other: Academic Detailing Other: Community Health Worker Other: Treatment as Usual (TAU) Not Applicable

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), 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness
Actual Study Start Date : July 14, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment as Usual (TAU)
Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services. Participants in this arm will receive no other study-related intervention.
 Other: Treatment as Usual (TAU)
Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services.
Experimental: AD + CHW

Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices.

Community Health Worker (CHW) will offer to support patients and prescribers to implement smoking cessation treatments that may be requested by patients and/or recommended by prescribers.

 Other: Academic Detailing
Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice.

Other: Community Health Worker
Community Health Worker (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training.
Experimental: AD Alone
Participants who are randomized to this condition will only not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing as described above.
 Other: Academic Detailing
Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice.


Outcome Measures
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Primary Outcome Measures :
  1. Effect of AD+CHW intervention on rates of biochemically-verified tobacco abstinence compared to those who received the TAU intervention [ Time Frame: 3 years ]
    The investigators hypothesize that those who receive AD+CHW will demonstrate higher rates of biochemically verified tobacco abstinence than those who receive usual care (TAU). The primary outcome will be the proportion of smokers who are abstinent at the Year Three Assessment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845440


Contacts
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Contact: Melissa C Maravic, PhD, MPH 617-643-1771 melissa.maravic@mgh.harvard.edu
Contact: Gladys Pachas, MD 617-643-1991 pachas.gladys@mgh.harvard.edu

Locations
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United States, Massachusetts
Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry Recruiting
Boston, Massachusetts, United States, 02114
Contact: Melissa C Maravic, PhD, MPH    617-643-1771    melissa.maravic@mgh.harvard.edu   
Contact: Gladys Pachas, MD    617-643-1991    pachas.gladys@mgh.harvard.edu   
Principal Investigator: A Eden Evins, MD, MPH         
Sub-Investigator: Sally Reyering, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Bay Cove Human Services
Brigham and Women's Hospital
University of Massachusetts, Amherst
Vinfen
Investigators
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Principal Investigator: A Eden Evins, MD, MPH Massachusetts General Hospital
More Information
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Responsible Party: A. Eden Evins, Director, Center for Addiction Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02845440    
Other Study ID Numbers: 2016P001036
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by A. Eden Evins, Massachusetts General Hospital:
Pragmatic Trial
Community Health Workers
Academic Detailing
Additional relevant MeSH terms:
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Disease
Schizophrenia
Depressive Disorder
Bipolar Disorder
Depressive Disorder, Major
 Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Bipolar and Related Disorders