Cigarette SmokingNCT02845440
Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness
A study testing Academic Detailing, Community Health Worker and Treatment as Usual (TAU) in people with Cigarette Smoking and Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking, Schizophrenia, Bipolar Disorder
- What is being tested?
- Academic Detailing, Community Health Worker and Treatment as Usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,165 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2016to 12 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- intellectual disability (IQ<70)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Cigarette Smoking, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Smoking Cessation
- Being tested
- Academic Detailing, Community Health Worker, Treatment as Usual (TAU)
- Keywords
- Pragmatic Trial, Community Health Workers, Academic Detailing
- Medical subject headings
- Cigarette Smoking, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic DetailingOther
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.
Community Health WorkerOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessment at end of year 2 of intervention
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
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.
Measured: Any use over assessments for years 1 or 2 of intervention
Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2
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.
Measured: 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 Cohorts 1 and 2
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.
Measured: 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 Cohorts 1 and 2
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.
Measured: Assessment at end of year 2 of intervention
Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1
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.
Measured: Assessment at end of year 2 of intervention
Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2
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.
Measured: Assessment at end of year 2 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start14 Jul 2016
- Primary completion2 Feb 2020
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bay Cove Human Services, Brigham and Women's Hospital, University of Massachusetts, Amherst, Vinfen
- Responsible party
- Principal investigator, A. Eden Evins, Massachusetts General Hospital
- Investigators
- A Eden Evins, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845440
- Sponsor's protocol ID
- 2016P001036
- Status last verified
- Feb 2022
- First submitted
- 20 Jul 2016
- Last updated
- 19 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Foo CYS, Potter K, Nielsen L, Rohila A, Maravic MC, Schnitzer K, Pachas GN, Levy DE, Reyering S, Thorndike AN, Cather C, Evins AE. Implementation of Community Health Worker Support for Tobacco Cessation: A Mixed-Methods Study. Psychiatr Serv. 2025 Jan 1;76(1):30-40. doi: 10.1176/appi.ps.20240044. Epub 2024 Aug 9.
PubMed 39118574Evins 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.
PubMed 36349498
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT02845440
- Acronym / sponsor ID
- 2016P001036
- Conditions
- Cigarette Smoking, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Smoking Cessation
- Keywords
- Pragmatic Trial, Community Health Workers, Academic Detailing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,165 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Bay Cove Human Services, Brigham and Women's Hospital, University of Massachusetts, Amherst, Vinfen
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Posted 19 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) - Cohort 1 | Active comparator | 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. 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. |
| AD + CHW - Cohort 1 | Experimental | Other: Academic Detailing, Other: Community Health WorkerAcademic 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. |
| AD - Cohort 1 | Experimental | Other: Academic DetailingParticipant 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. |
| CHW - Cohort 2 | Experimental | Other: Community Health WorkerCommunity 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. |
| Treatment as Usual (TAU) - Cohort 2 | Active comparator | 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. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- intellectual disability (IQ<70)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Academic DetailingAcademic 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 | AD + CHW - Cohort 1, AD - Cohort 1 |
| Community Health WorkerCommunity 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. | Other | AD + CHW - Cohort 1, CHW - Cohort 2 |
| 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. | Other | Treatment as Usual (TAU) - Cohort 1, Treatment as Usual (TAU) - Cohort 2 |
Primary outcome
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.
11 secondary outcomes
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
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
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 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
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
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
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
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 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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39118574Foo CYS, Potter K, Nielsen L, Rohila A, Maravic MC, Schnitzer K, Pachas GN, Levy DE, Reyering S, Thorndike AN, Cather C, Evins AE. Implementation of Community Health Worker Support for Tobacco Cessation: A Mixed-Methods Study. Psychiatr Serv. 2025 Jan 1;76(1):30-40. doi: 10.1176/appi.ps.20240044. Epub 2024 Aug 9.
- Derived from this study: PubMed 36349498Evins 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Eden Evins, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Academic Detailing, Community Health Worker and Treatment as Usual (TAU) in people with Cigarette Smoking and Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02845440, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.