Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness

• ClinicalTrials.gov Identifier: NCT02845440
• Recruitment Status: Completed
• First Posted: July 27, 2016
• Results First Posted: April 19, 2022
• Last Update Posted: April 19, 2022
• Sponsor: Massachusetts General Hospital
• 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

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.

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), 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1165 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
• Actual Primary Completion Date: February 2, 2020
• Actual Study Completion Date: January 12, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Treatment as Usual (TAU) - Cohort 1; 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.Cohort 1 (AD-eligible) comprised participants seen in primary care clinics serving ≥3 enrolled participants.	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 - Cohort 1; 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 - Cohort 1; Participant in this arm will have Academic Detailing offered to their primary care clinical staff as described above. Participants who are randomized to this condition will not be offered Community Health Worker support.	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.
Experimental: CHW - Cohort 2; 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: 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.
Active Comparator: Treatment as Usual (TAU) - Cohort 2; 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. Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants	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.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1 [ Time Frame: Assessment at end of year 2 of intervention ]
   Three pairwise comparisons between usual care (TAU), AD+CHW, and AD for number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of tobacco abstinence than those who receive TAU, (2) those who receive AD will demonstrate higher rates of tobacco abstinence than those who received TAU, and (3) those who receive AD+CHW will demonstrate higher rates of tobacco abstinence than those who received AD.

Secondary Outcome Measures :

1. Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 [ Time Frame: Any use over assessments for years 1 or 2 of intervention ]
   Two comparisons, usual care (TAU) versus AD+CHW and TAU versus AD, for use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention. The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of medication use than those who received TAU, and (2) those who receive AD will demonstrate higher rates of medication use than those who received TAU.
2. Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 [ Time Frame: Any use over assessments for years 1 or 2 of intervention ]
   Two comparisons, usual care (TAU) versus AD+CHW and TAU versus AD, for use of varenicline during assessments for years 1 and 2 of the intervention. The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of varenicline use than those who received TAU, and (2) those who receive AD will demonstrate higher rates of varenicline use than those who received TAU.
3. Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 [ Time Frame: Assessment at end of year 2 of intervention ]
   Effect of use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that those who used any medication will exhibit higher rates of tobacco abstinence than those who did not use any medications. The indirect effect of AD+CHW and AD interventions on abstinence rates with any TUD medication use as a mediator will be also be assessed.
4. Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 [ Time Frame: Assessment at end of year 2 of intervention ]
   Effect of use of varenicline during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that those who used varenicline will exhibit higher rates of tobacco abstinence than those who did not use any varenicline. The indirect effect of AD+CHW and AD interventions on abstinence rates with any TUD medication use as a mediator will be also be assessed.
5. Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2 [ Time Frame: Assessment at end of year 2 of intervention ]
   Comparisons between (1) CHW (pooled over AD+CHW and CHW) and (2) AD (pooled over AD+CHW and AD) compared to usual care (TAU) on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that (1) those who receive CHW support will demonstrate higher rates of tobacco abstinence than those who receive TAU, and (2) those with AD exposure will demonstrate higher rates of tobacco abstinence than those who received TAU. To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a factorial design.
6. 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 [ Time Frame: Any use over assessments for years 1 or 2 of intervention ]
   Effects of CHW (pooled over AD+CHW and CHW) and AD (pooled over AD+CHW and AD) compared to usual care (TAU) on number of participants who use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention. The investigators hypothesize that (1) those who receive CHW support will demonstrate higher rates of medication use than those who receive TAU, and (2) those with AD exposure will demonstrate higher rates of medication use than those who received TAU. To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a factorial design.
7. Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 [ Time Frame: Any use over assessments for years 1 or 2 of intervention ]
   Effects of CHW (pooled over AD+CHW and CHW) and AD (pooled over AD+CHW and AD) compared to usual care (TAU) on number of participants who use varenicline during assessments for years 1 and 2 of the intervention. The investigators hypothesize that (1) those who receive CHW support will demonstrate higher rates of varenicline use than those who receive TAU, and (2) those with AD exposure will demonstrate higher rates of varenicline use than those who received TAU. To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a factorial design.
8. 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 [ Time Frame: Assessment at end of year 2 of intervention ]
   Effect of use of any first line, evidence-based TUD medication during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that those who used any medication will exhibit higher rates of tobacco abstinence than those who did not use any medications. To make use of all the data, the hypothesis will be assessed in Cohorts 1 and 2 via analysis of a factorial design. The indirect effect of CHW and AD interventions on abstinence rates with any TUD medication use as a mediator will be also be assessed.
9. Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 [ Time Frame: Assessment at end of year 2 of intervention ]
   Effect of use of varenicline during assessments for years 1 and 2 of the intervention on number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that those who used varenicline will exhibit higher rates of tobacco abstinence than those who did not use any varenicline. To make use of all the data, the hypothesis will be assessed in Cohorts 1 and 2 via analysis of a factorial design. The indirect effect of CHW and AD interventions on abstinence rates with varenicline use as a mediator will be also be assessed.
10. Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1 [ Time Frame: Assessment at end of year 2 of intervention ]
    Three pairwise comparisons between usual care (TAU), AD+CHW, and AD for health-related quality of life at the intervention year 2 assessment as assessed with the single-item self-reported Overall Health (SF-1) scale (measured on a 5-point scale from 1 = 'poor' to 5 = 'excellent'). The investigators hypothesize that (1) those who receive AD+CHW will demonstrate improved quality of life compared than those who receive TAU, (2) those who receive AD will demonstrate improved quality of life compared those who received TAU, and (3) those who receive AD+CHW will demonstrate improved quality of life compared than those who received AD.
11. Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2 [ Time Frame: Assessment at end of year 2 of intervention ]
    Comparisons between (1) CHW (pooled over AD+CHW and CHW) and (2) AD (pooled over AD+CHW and AD) compared to usual care (TAU) on health-related quality of life at the intervention year 2 assessment as assessed with the single-item self-reported Overall Health (SF-1) scale (measured on a 5-point scale from 1 = 'poor' to 5 = 'excellent'). The investigators hypothesize that (1) those who receive CHW support will demonstrate improved quality of life compared to those who receive TAU, and (2) those with AD exposure will demonstrate improved quality of life compared to those who received TAU. To make use of all the data, hypotheses will be assessed in Cohorts 1 and 2 via analysis of a factorial design.

Eligibility Criteria

• 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

Locations

United States, Massachusetts

Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

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

  Study Documents (Full-Text)

Documents provided by A. Eden Evins, Massachusetts General Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] September 29, 2021

More Information

• 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
• Results First Posted: April 19, 2022
• Last Update Posted: April 19, 2022
• Last Verified: February 2022

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:

Disease; Schizophrenia; Depressive Disorder; Bipolar Disorder; Mental Disorders; Depressive Disorder, Major; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Mood Disorders; Bipolar and Related Disorders