Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness

NCT02845440 | Completed Results DMC

• 1 other identifier: 2016P001036
• Study Type: interventional
• Target: 1,165
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Smoking Cessation

Keywords

Pragmatic Trial; Community Health Workers; Academic Detailing

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1

  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.

  Assessment at end of year 2 of intervention

Secondary Outcomes (11)

• Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1

  Any use over assessments for years 1 or 2 of intervention

• Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1

  Any use over assessments for years 1 or 2 of intervention

• Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1

  Assessment at end of year 2 of intervention

• Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1

  Assessment at end of year 2 of intervention

• Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2

  Assessment at end of year 2 of intervention

Study Arms (5)

Treatment as Usual (TAU) - Cohort 1

ACTIVE COMPARATOR

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)

AD + CHW - Cohort 1

EXPERIMENTAL

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; Other: Community Health Worker

AD - Cohort 1

EXPERIMENTAL

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

CHW - Cohort 2

EXPERIMENTAL

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

Treatment as Usual (TAU) - Cohort 2

ACTIVE COMPARATOR

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)

Interventions

Academic Detailing OTHER

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.

AD + CHW - Cohort 1; AD - Cohort 1

Community Health Worker OTHER

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.

AD + CHW - Cohort 1; CHW - Cohort 2

Treatment as Usual (TAU) OTHER

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.

Treatment as Usual (TAU) - Cohort 1; Treatment as Usual (TAU) - Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• intellectual disability (IQ\<70)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bay Cove Human Services: collaborator
• Brigham and Women's Hospital: collaborator
• University of Massachusetts, Amherst: collaborator
• Vinfen: collaborator

Study Sites (1)

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

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Evins AE, Cather C, Maravic MC, Reyering S, Pachas GN, Thorndike AN, Levy DE, Fung V, Fischer MA, Schnitzer K, Pratt S, Fetters MD, Deeb B, Potter K, Schoenfeld DA. A Pragmatic Cluster-Randomized Trial of Provider Education and Community Health Worker Support for Tobacco Cessation. Psychiatr Serv. 2023 Apr 1;74(4):365-373. doi: 10.1176/appi.ps.20220187. Epub 2022 Nov 9.

  PMID: 36349498 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Schizophrenia; Bipolar Disorder; Depressive Disorder, Major; Smoking Cessation

Interventions

Community Health Workers; Therapeutics

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder; Health Behavior

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Limitations and Caveats

Annual survey didn't allow reliable discernment of sequenced monotherapies/combination therapy; Enrollment required SMI-related functional impairment severe enough for DMH-contracted psychiatric rehabilitation service eligibility; results may not generalize to individuals with SMI of lesser severity; Substantial loss to follow up, although no apparent differential dropout across randomization arms.

Results Point of Contact

• Title: A. Eden Evins
• Organization: Massachusetts General Hospital, Center for Addiction Medicine

aeevins@mgh.harvard.edu

6177333131

Study Officials

• A Eden Evins, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Addiction Medicine

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 27, 2016
• Study Start: July 14, 2016
• Primary Completion: February 2, 2020
• Study Completion: January 12, 2021
• Last Updated: April 19, 2022
• Results First Posted: April 19, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)