Trial Outcomes & Findings for Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness (NCT NCT02845440)

Last Updated: 2022-04-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1165 participants

Primary outcome timeframe

Assessment at end of year 2 of intervention

Results posted on

2022-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	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	AD + CHW - Cohort 1 Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 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 that may be requested by patients and/or 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.	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.
Overall Study STARTED	333	336	341	78	77
Overall Study COMPLETED	201	203	204	49	39
Overall Study NOT COMPLETED	132	133	137	29	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment as Usual (TAU) Cohort 1 n=333 Participants 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 n=336 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=341 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 n=78 Participants 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 n=77 Participants Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.	Total n=1165 Participants Total of all reporting groups
Age, Continuous	48.4 years STANDARD_DEVIATION 13.2 • n=5 Participants	47.4 years STANDARD_DEVIATION 12.7 • n=7 Participants	47.3 years STANDARD_DEVIATION 12.9 • n=5 Participants	44.7 years STANDARD_DEVIATION 14.2 • n=4 Participants	46 years STANDARD_DEVIATION 14.4 • n=21 Participants	47.4 years STANDARD_DEVIATION 13.1 • n=10 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	103 Participants n=7 Participants	105 Participants n=5 Participants	32 Participants n=4 Participants	29 Participants n=21 Participants	368 Participants n=10 Participants
Sex: Female, Male Male	234 Participants n=5 Participants	233 Participants n=7 Participants	236 Participants n=5 Participants	46 Participants n=4 Participants	48 Participants n=21 Participants	797 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=5 Participants	60 Participants n=7 Participants	69 Participants n=5 Participants	19 Participants n=4 Participants	9 Participants n=21 Participants	199 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	291 Participants n=5 Participants	276 Participants n=7 Participants	272 Participants n=5 Participants	59 Participants n=4 Participants	68 Participants n=21 Participants	966 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized White	149 Participants n=5 Participants	165 Participants n=7 Participants	158 Participants n=5 Participants	59 Participants n=4 Participants	52 Participants n=21 Participants	583 Participants n=10 Participants
Race/Ethnicity, Customized Black	132 Participants n=5 Participants	126 Participants n=7 Participants	136 Participants n=5 Participants	13 Participants n=4 Participants	15 Participants n=21 Participants	422 Participants n=10 Participants
Race/Ethnicity, Customized Asian	18 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	41 Participants n=10 Participants
Race/Ethnicity, Customized Other	17 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	43 Participants n=10 Participants
Race/Ethnicity, Customized Multi-race	17 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	76 Participants n=10 Participants
Participants living in supervised Housing (Y/N) Yes	144 Participants n=5 Participants	146 Participants n=7 Participants	158 Participants n=5 Participants	15 Participants n=4 Participants	17 Participants n=21 Participants	480 Participants n=10 Participants
Participants living in supervised Housing (Y/N) No	189 Participants n=5 Participants	190 Participants n=7 Participants	183 Participants n=5 Participants	63 Participants n=4 Participants	60 Participants n=21 Participants	685 Participants n=10 Participants
SF-1 M(SD)	3.1 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants	3.1 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	3.2 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants	3.1 units on a scale STANDARD_DEVIATION 1.1 • n=4 Participants	3.2 units on a scale STANDARD_DEVIATION 1.1 • n=21 Participants	3.1 units on a scale STANDARD_DEVIATION 1.1 • n=10 Participants
Expired Carbon Monoxide M(SD)	25 ppm (parts per million) STANDARD_DEVIATION 25.7 • n=5 Participants	22.7 ppm (parts per million) STANDARD_DEVIATION 18.5 • n=7 Participants	22.6 ppm (parts per million) STANDARD_DEVIATION 17.2 • n=5 Participants	23.1 ppm (parts per million) STANDARD_DEVIATION 19.4 • n=4 Participants	20.9 ppm (parts per million) STANDARD_DEVIATION 14.8 • n=21 Participants	23.2 ppm (parts per million) STANDARD_DEVIATION 20.3 • n=10 Participants
HSI M(SD)	2.9 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	2.7 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	2.9 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	2.9 units on a scale STANDARD_DEVIATION 1.6 • n=4 Participants	3 units on a scale STANDARD_DEVIATION 1.6 • n=21 Participants	2.9 units on a scale STANDARD_DEVIATION 1.6 • n=10 Participants
Number of Tobacco Products per day M(SD)	15.7 products per day STANDARD_DEVIATION 10.6 • n=5 Participants	14.9 products per day STANDARD_DEVIATION 9.6 • n=7 Participants	16 products per day STANDARD_DEVIATION 11.4 • n=5 Participants	15.8 products per day STANDARD_DEVIATION 9.7 • n=4 Participants	15.5 products per day STANDARD_DEVIATION 10.5 • n=21 Participants	15.5 products per day STANDARD_DEVIATION 10.5 • n=10 Participants
Participants that use Cigarettes %(n)	281 Participants n=5 Participants	272 Participants n=7 Participants	289 Participants n=5 Participants	72 Participants n=4 Participants	61 Participants n=21 Participants	975 Participants n=10 Participants
Participants that use Little cigars %(n)	105 Participants n=5 Participants	114 Participants n=7 Participants	114 Participants n=5 Participants	15 Participants n=4 Participants	22 Participants n=21 Participants	370 Participants n=10 Participants
Participants that use Hand rolled cigarettes %(n)	26 Participants n=5 Participants	27 Participants n=7 Participants	21 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	85 Participants n=10 Participants
Participants that use E-cigarettes %(n)	6 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	21 Participants n=10 Participants
Participants that received a Physician recommendation to quit smoking %(n)	231 Participants n=5 Participants	205 Participants n=7 Participants	217 Participants n=5 Participants	49 Participants n=4 Participants	47 Participants n=21 Participants	749 Participants n=10 Participants
Participants that were prescribed a medication to aid cessation %(n)	130 Participants n=5 Participants	94 Participants n=7 Participants	108 Participants n=5 Participants	22 Participants n=4 Participants	24 Participants n=21 Participants	378 Participants n=10 Participants
Participants that used Varenicline %(n)	30 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	66 Participants n=10 Participants
Participants that used Bupropion %(n)	6 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	15 Participants n=10 Participants
Participants that used Nicotine Replacement Therapy (any form) %(n)	124 Participants n=5 Participants	89 Participants n=7 Participants	99 Participants n=5 Participants	20 Participants n=4 Participants	23 Participants n=21 Participants	355 Participants n=10 Participants
Cardiovascular/respiratory illness %(n)	206 Participants n=5 Participants	175 Participants n=7 Participants	180 Participants n=5 Participants	42 Participants n=4 Participants	45 Participants n=21 Participants	648 Participants n=10 Participants
Other smoking related illness %(n)	40 Participants n=5 Participants	36 Participants n=7 Participants	44 Participants n=5 Participants	13 Participants n=4 Participants	14 Participants n=21 Participants	147 Participants n=10 Participants

PRIMARY outcome

Timeframe: Assessment at end of year 2 of intervention

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1	13 Participants	32 Participants	19 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
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 TUD med	112 Participants	121 Participants	83 Participants	—	—
Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 No TUD med	152 Participants	138 Participants	181 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 Varenicline	34 Participants	72 Participants	30 Participants	—	—
Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 No varenicline	230 Participants	187 Participants	234 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 Any TUD med + abstinent	5 Participants	24 Participants	7 Participants	—	—
Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 No TUD med + abstinent	8 Participants	8 Participants	12 Participants	—	—
Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 Any TUD med + not abstinent	107 Participants	97 Participants	76 Participants	—	—
Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 No TUD med + not abstinent	144 Participants	130 Participants	169 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 Varenicline + abstinent	1 Participants	17 Participants	4 Participants	—	—
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 No varenicline + abstinent	12 Participants	15 Participants	15 Participants	—	—
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 Varenicline + not abstinent	33 Participants	55 Participants	26 Participants	—	—
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 No varenicline + not abstinent	218 Participants	172 Participants	219 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 n=57 Participants 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 n=57 Participants Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2	13 Participants	32 Participants	19 Participants	11 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 n=57 Participants 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 n=57 Participants Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
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 Any TUD medication	112 Participants	121 Participants	83 Participants	30 Participants	24 Participants
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 None	152 Participants	138 Participants	181 Participants	27 Participants	33 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 n=57 Participants 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 n=57 Participants Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 Other	230 Participants	187 Participants	234 Participants	42 Participants	51 Participants
Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 Varenicline	34 Participants	72 Participants	30 Participants	15 Participants	6 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 n=57 Participants 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 n=57 Participants Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
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 Any TUD med + abstinence	5 Participants	24 Participants	7 Participants	7 Participants	2 Participants
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 No TUD med + abstinence	8 Participants	8 Participants	12 Participants	4 Participants	6 Participants
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 Any TUD med + no abstinence	107 Participants	100 Participants	78 Participants	23 Participants	22 Participants
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 No TUD med + no abstinence	144 Participants	127 Participants	167 Participants	23 Participants	27 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=264 Participants 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 n=259 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=264 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 n=57 Participants 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 n=57 Participants Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 Varenicline + abstinence	1 Participants	17 Participants	4 Participants	5 Participants	0 Participants
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 No varenicline + abstinence	12 Participants	15 Participants	15 Participants	6 Participants	8 Participants
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 Varenicline + no abstinence	33 Participants	55 Participants	26 Participants	10 Participants	6 Participants
Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 No varenicline + no abstinence	218 Participants	172 Participants	219 Participants	36 Participants	43 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=252 Participants 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 n=248 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=253 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1	3.02 score on a scale Standard Deviation 0.96	3.13 score on a scale Standard Deviation 1.06	3.08 score on a scale Standard Deviation 0.99	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual (TAU) Cohort 1 n=252 Participants 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 n=248 Participants Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=253 Participants Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 n=53 Participants 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) Cohort 2 n=55 Participants Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2	3.02 score on a scale Standard Deviation 0.96	3.13 score on a scale Standard Deviation 1.06	3.08 score on a scale Standard Deviation 0.99	3.11 score on a scale Standard Deviation 1.06	3.35 score on a scale Standard Deviation 0.90

Adverse Events

Treatment as Usual (TAU) - Cohort 1

Serious events: 90 serious events

Other events: 13 other events

Deaths: 14 deaths

AD + CHW - Cohort 1

Serious events: 119 serious events

Other events: 8 other events

Deaths: 18 deaths

AD - Cohort 1

Serious events: 108 serious events

Other events: 7 other events

Deaths: 16 deaths

CHW - Cohort 2

Serious events: 26 serious events

Other events: 2 other events

Deaths: 3 deaths

Treatment as Usual (TAU) - Cohort 2

Serious events: 24 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment as Usual (TAU) - Cohort 1 n=333 participants at risk 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 n=336 participants at risk Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=341 participants at risk Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 n=78 participants at risk 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) - Cohort 2 n=77 participants at risk Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
General disorders Medical hospitalization	12.9% 43/333 • Number of events 77 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	17.6% 59/336 • Number of events 101 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	13.8% 47/341 • Number of events 97 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	12.8% 10/78 • Number of events 26 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	13.0% 10/77 • Number of events 22 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.
Psychiatric disorders Psychiatric hospitalization	19.8% 66/333 • Number of events 168 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	24.4% 82/336 • Number of events 224 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	22.0% 75/341 • Number of events 182 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	24.4% 19/78 • Number of events 80 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	20.8% 16/77 • Number of events 45 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.

Other adverse events

Other adverse events
Measure	Treatment as Usual (TAU) - Cohort 1 n=333 participants at risk 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 n=336 participants at risk Academic Detailing: (AD) is a targeted continuing medical education 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. The aim of AD is to help clinicians understand and adopt targeted evidence-based practices. 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 - Cohort 1 n=341 participants at risk Participants who are randomized to this condition will not be offered additional Community Health Worker services; however, the participant's primary care clinic will receive Academic Detailing 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.	CHW - Cohort 2 n=78 participants at risk 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 that may be requested by patients and/or 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.	Treatment as Usual (TAU) - Cohort 2 n=77 participants at risk Cohort 2 (AD-ineligible) comprised participants whose primary care clinic served ≤2 enrolled participants. 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.
Social circumstances Incarceration	3.9% 13/333 • Number of events 13 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	2.4% 8/336 • Number of events 8 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	2.1% 7/341 • Number of events 7 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	2.6% 2/78 • Number of events 2 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.	1.3% 1/77 • Number of events 1 • 2 years We summarized the following adverse events comparing the intervention study arms: deceased, incarceration, med hospitalization, and psych hospitalization.

Additional Information

A. Eden Evins

Massachusetts General Hospital, Center for Addiction Medicine

Phone: 6177333131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place