Cigarette Smoking, Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Smoking Cessation
Conditions
Keywords
Pragmatic Trial, Community Health Workers, Academic Detailing
Brief summary
The overall aim of this study is to test the effect of academic detailing (i.e. provider-level educational intervention focused on evidence-based smoking cessation treatment for those with psychiatric illness) and community health worker (CHW) support on the provision and utilization of standard of care smoking cessation treatment to those with serious mental illness (SMI) and smoking cessation rates for adults with SMI who smoke.
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.
Interventions
OTHERAcademic 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.
OTHERCommunity Health Worker
Community Health Worker (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training.
OTHERTreatment 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.
Sponsors
Bay Cove Human Services
Brigham and Women's Hospital
University of Massachusetts, Amherst
Vinfen
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * adult (18+ years) * current smoker * current diagnosis of SMI (e.g. schizophrenia, bipolar disorder, major depressive disorder, etc...) * currently receiving psychiatric rehabilitation services through CBFS and ACT programs at Bay Cove Human Services and Vinfen Corporation Exclusion: * intellectual disability (IQ\<70)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1 | Assessment at end of year 2 of intervention | Three pairwise comparisons between usual care (TAU), AD+CHW, and AD for number of participants who are abstinent (defined as 7-day point prevalence tobacco abstinence confirmed with an expired CO of 5 ppm or less) at the intervention year 2 assessment. The investigators hypothesize that (1) those who receive AD+CHW will demonstrate higher rates of tobacco abstinence than those who receive TAU, (2) those who receive AD will demonstrate higher rates of tobacco abstinence than those who received TAU, and (3) those who receive AD+CHW will demonstrate higher rates of tobacco abstinence than those who received AD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 | Any use over assessments for years 1 or 2 of intervention | 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. |
| Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | Assessment at end of year 2 of intervention | Effect of 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. |
| Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | Assessment at end of year 2 of intervention | 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. |
| Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2 | Assessment at end of year 2 of intervention | 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. |
| 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 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. |
| Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 | Any use over assessments for years 1 or 2 of intervention | 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. |
| 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 | 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. |
| Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 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. |
| Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1 | 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. |
| Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 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. |
| Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 333 |
| 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. | 336 |
| 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. | 341 |
| 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. | 78 |
| 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. | 77 |
| Total | 1,165 |
Baseline characteristics
| Characteristic | Treatment as Usual (TAU) Cohort 1 | AD + CHW - Cohort 1 | AD - Cohort 1 | CHW - Cohort 2 | Treatment as Usual (TAU) Cohort 2 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 13.2 | 47.4 years STANDARD_DEVIATION 12.7 | 47.3 years STANDARD_DEVIATION 12.9 | 44.7 years STANDARD_DEVIATION 14.2 | 46 years STANDARD_DEVIATION 14.4 | 47.4 years STANDARD_DEVIATION 13.1 |
| Cardiovascular/respiratory illness %(n) | 206 Participants | 175 Participants | 180 Participants | 42 Participants | 45 Participants | 648 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 60 Participants | 69 Participants | 19 Participants | 9 Participants | 199 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 291 Participants | 276 Participants | 272 Participants | 59 Participants | 68 Participants | 966 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Expired Carbon Monoxide M(SD) | 25 ppm (parts per million) STANDARD_DEVIATION 25.7 | 22.7 ppm (parts per million) STANDARD_DEVIATION 18.5 | 22.6 ppm (parts per million) STANDARD_DEVIATION 17.2 | 23.1 ppm (parts per million) STANDARD_DEVIATION 19.4 | 20.9 ppm (parts per million) STANDARD_DEVIATION 14.8 | 23.2 ppm (parts per million) STANDARD_DEVIATION 20.3 |
| HSI M(SD) | 2.9 units on a scale STANDARD_DEVIATION 1.6 | 2.7 units on a scale STANDARD_DEVIATION 1.6 | 2.9 units on a scale STANDARD_DEVIATION 1.7 | 2.9 units on a scale STANDARD_DEVIATION 1.6 | 3 units on a scale STANDARD_DEVIATION 1.6 | 2.9 units on a scale STANDARD_DEVIATION 1.6 |
| Number of Tobacco Products per day M(SD) | 15.7 products per day STANDARD_DEVIATION 10.6 | 14.9 products per day STANDARD_DEVIATION 9.6 | 16 products per day STANDARD_DEVIATION 11.4 | 15.8 products per day STANDARD_DEVIATION 9.7 | 15.5 products per day STANDARD_DEVIATION 10.5 | 15.5 products per day STANDARD_DEVIATION 10.5 |
| Other smoking related illness %(n) | 40 Participants | 36 Participants | 44 Participants | 13 Participants | 14 Participants | 147 Participants |
| Participants living in supervised Housing (Y/N) No | 189 Participants | 190 Participants | 183 Participants | 63 Participants | 60 Participants | 685 Participants |
| Participants living in supervised Housing (Y/N) Yes | 144 Participants | 146 Participants | 158 Participants | 15 Participants | 17 Participants | 480 Participants |
| Participants that received a Physician recommendation to quit smoking %(n) | 231 Participants | 205 Participants | 217 Participants | 49 Participants | 47 Participants | 749 Participants |
| Participants that use Cigarettes %(n) | 281 Participants | 272 Participants | 289 Participants | 72 Participants | 61 Participants | 975 Participants |
| Participants that used Bupropion %(n) | 6 Participants | 1 Participants | 5 Participants | 2 Participants | 1 Participants | 15 Participants |
| Participants that used Nicotine Replacement Therapy (any form) %(n) | 124 Participants | 89 Participants | 99 Participants | 20 Participants | 23 Participants | 355 Participants |
| Participants that used Varenicline %(n) | 30 Participants | 17 Participants | 14 Participants | 3 Participants | 2 Participants | 66 Participants |
| Participants that use E-cigarettes %(n) | 6 Participants | 1 Participants | 8 Participants | 2 Participants | 4 Participants | 21 Participants |
| Participants that use Hand rolled cigarettes %(n) | 26 Participants | 27 Participants | 21 Participants | 5 Participants | 6 Participants | 85 Participants |
| Participants that use Little cigars %(n) | 105 Participants | 114 Participants | 114 Participants | 15 Participants | 22 Participants | 370 Participants |
| Participants that were prescribed a medication to aid cessation %(n) | 130 Participants | 94 Participants | 108 Participants | 22 Participants | 24 Participants | 378 Participants |
| Race/Ethnicity, Customized Asian | 18 Participants | 10 Participants | 10 Participants | 2 Participants | 1 Participants | 41 Participants |
| Race/Ethnicity, Customized Black | 132 Participants | 126 Participants | 136 Participants | 13 Participants | 15 Participants | 422 Participants |
| Race/Ethnicity, Customized Multi-race | 17 Participants | 24 Participants | 26 Participants | 3 Participants | 6 Participants | 76 Participants |
| Race/Ethnicity, Customized Other | 17 Participants | 11 Participants | 11 Participants | 1 Participants | 3 Participants | 43 Participants |
| Race/Ethnicity, Customized White | 149 Participants | 165 Participants | 158 Participants | 59 Participants | 52 Participants | 583 Participants |
| Sex: Female, Male Female | 99 Participants | 103 Participants | 105 Participants | 32 Participants | 29 Participants | 368 Participants |
| Sex: Female, Male Male | 234 Participants | 233 Participants | 236 Participants | 46 Participants | 48 Participants | 797 Participants |
| SF-1 M(SD) | 3.1 units on a scale STANDARD_DEVIATION 1.1 | 3.1 units on a scale STANDARD_DEVIATION 1.1 | 3.2 units on a scale STANDARD_DEVIATION 1.1 | 3.1 units on a scale STANDARD_DEVIATION 1.1 | 3.2 units on a scale STANDARD_DEVIATION 1.1 | 3.1 units on a scale STANDARD_DEVIATION 1.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 14 / 333 | 18 / 336 | 16 / 341 | 3 / 78 | 0 / 77 |
| other Total, other adverse events | 13 / 333 | 8 / 336 | 7 / 341 | 2 / 78 | 1 / 77 |
| serious Total, serious adverse events | 90 / 333 | 119 / 336 | 108 / 341 | 26 / 78 | 24 / 77 |
Outcome results
Primary
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.
Time frame: Assessment at end of year 2 of intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1 | 13 Participants |
| AD + CHW - Cohort 1 | Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1 | 32 Participants |
| AD - Cohort 1 | Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1 | 19 Participants |
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.01395% CI: [1.2, 4.79]Regression, Logistic
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.48195% CI: [0.62, 2.74]Regression, Logistic
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.03695% CI: [1.04, 3.24]Regression, Logistic
Secondary
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.
Time frame: Assessment at end of year 2 of intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| AD + CHW - Cohort 1 | 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 | 97 Participants |
| AD + CHW - Cohort 1 | 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 |
| AD + CHW - Cohort 1 | 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 | 130 Participants |
| AD + CHW - Cohort 1 | 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 | 24 Participants |
| AD - Cohort 1 | 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 | 169 Participants |
| AD - Cohort 1 | 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 | 7 Participants |
| AD - Cohort 1 | 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 | 76 Participants |
| AD - Cohort 1 | 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 | 12 Participants |
Comparison: Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.05695% CI: [0.99, 2.51]Regression, Logistic
Secondary
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.
Time frame: Assessment at end of year 2 of intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| AD + CHW - Cohort 1 | 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 | 24 Participants |
| AD + CHW - Cohort 1 | 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 | 127 Participants |
| AD + CHW - Cohort 1 | 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 |
| AD + CHW - Cohort 1 | 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 | 100 Participants |
| AD - Cohort 1 | 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 | 167 Participants |
| AD - Cohort 1 | 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 | 12 Participants |
| AD - Cohort 1 | 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 | 78 Participants |
| AD - Cohort 1 | 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 | 7 Participants |
| CHW - Cohort 2 | 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 | 7 Participants |
| CHW - Cohort 2 | 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 | 4 Participants |
| CHW - Cohort 2 | 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 | 23 Participants |
| CHW - Cohort 2 | 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 | 23 Participants |
| Treatment as Usual (TAU) Cohort 2 | 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 | 27 Participants |
| Treatment as Usual (TAU) Cohort 2 | 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 | 22 Participants |
| Treatment as Usual (TAU) Cohort 2 | 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 | 6 Participants |
| Treatment as Usual (TAU) Cohort 2 | 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 | 2 Participants |
Comparison: Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.15895% CI: [0.92, 2.2]Regression, Logistic
Secondary
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.
Time frame: Assessment at end of year 2 of intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | Varenicline + abstinent | 1 Participants |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| AD + CHW - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | No varenicline + not abstinent | 172 Participants |
| AD + CHW - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | Varenicline + abstinent | 17 Participants |
| AD + CHW - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | Varenicline + not abstinent | 55 Participants |
| AD + CHW - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | No varenicline + abstinent | 15 Participants |
| AD - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | No varenicline + not abstinent | 219 Participants |
| AD - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | No varenicline + abstinent | 15 Participants |
| AD - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | Varenicline + not abstinent | 26 Participants |
| AD - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 | Varenicline + abstinent | 4 Participants |
Comparison: Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as varenicline use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.01295% CI: [1.16, 3.33]Regression, Logistic
Secondary
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.
Time frame: Assessment at end of year 2 of intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| AD + CHW - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 | Varenicline + abstinence | 17 Participants |
| AD + CHW - Cohort 1 | 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 | 172 Participants |
| AD + CHW - Cohort 1 | 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 | 15 Participants |
| AD + CHW - Cohort 1 | 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 | 55 Participants |
| AD - Cohort 1 | 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 | 219 Participants |
| AD - Cohort 1 | 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 | 15 Participants |
| AD - Cohort 1 | 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 | 26 Participants |
| AD - Cohort 1 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 | Varenicline + abstinence | 4 Participants |
| CHW - Cohort 2 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 | Varenicline + abstinence | 5 Participants |
| CHW - Cohort 2 | 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 | 6 Participants |
| CHW - Cohort 2 | 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 | 36 Participants |
| CHW - Cohort 2 | 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 | 10 Participants |
| Treatment as Usual (TAU) Cohort 2 | 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 | 43 Participants |
| Treatment as Usual (TAU) Cohort 2 | 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 | 6 Participants |
| Treatment as Usual (TAU) Cohort 2 | 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 | 8 Participants |
| Treatment as Usual (TAU) Cohort 2 | Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 | Varenicline + abstinence | 0 Participants |
Comparison: Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as varenicline use and a clinic-varying random intercept. Regression coefficients and mediation analysis estimates were pooled using Rubin's rule over 10 imputation runs.p-value: 0.01395% CI: [1.14, 3.13]Regression, Logistic
Secondary
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.
Time frame: Assessment at end of year 2 of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | 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 |
| AD + CHW - Cohort 1 | Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1 | 3.13 score on a scale | Standard Deviation 1.06 |
| AD - Cohort 1 | Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1 | 3.08 score on a scale | Standard Deviation 0.99 |
Comparison: The model had a clinic varying random intercept. This statistical model included cohort 1: TAU , AD, and AD+CHWp-value: 0.50595% CI: [-0.16, 0.33]Regression, Linear
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.84895% CI: [-0.22, 0.27]Regression, Linear
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.52995% CI: [-0.13, 0.25]Regression, Linear
Secondary
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.
Time frame: Assessment at end of year 2 of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | 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 |
| AD + CHW - Cohort 1 | Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 3.13 score on a scale | Standard Deviation 1.06 |
| AD - Cohort 1 | Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 3.08 score on a scale | Standard Deviation 0.99 |
| CHW - Cohort 2 | Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 3.11 score on a scale | Standard Deviation 1.06 |
| Treatment as Usual (TAU) Cohort 2 | Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 3.35 score on a scale | Standard Deviation 0.9 |
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.93795% CI: [-0.16, 0.18]Regression, Linear
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.68395% CI: [-0.19, 0.29]Regression, Linear
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.1995% CI: [-0.15, 0.74]Regression, Linear
Secondary
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.
Time frame: Assessment at end of year 2 of intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 13 Participants |
| AD + CHW - Cohort 1 | Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 32 Participants |
| AD - Cohort 1 | Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 19 Participants |
| CHW - Cohort 2 | Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 11 Participants |
| Treatment as Usual (TAU) Cohort 2 | Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2 | 8 Participants |
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.03295% CI: [1.05, 2.79]Regression, Logistic
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.37695% CI: [0.68, 2.75]Regression, Linear
Comparison: Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.p-value: 0.64595% CI: [0.42, 4.05]Regression, Logistic
Secondary
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.
Time frame: Any use over assessments for years 1 or 2 of intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 | Any TUD med | 112 Participants |
| Treatment as Usual (TAU) Cohort 1 | Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 | No TUD med | 152 Participants |
| AD + CHW - Cohort 1 | Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 | Any TUD med | 121 Participants |
| AD + CHW - Cohort 1 | Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 | No TUD med | 138 Participants |
| AD - Cohort 1 | Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 | Any TUD med | 83 Participants |
| AD - Cohort 1 | Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 | No TUD med | 181 Participants |
Comparison: The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.p-value: 0.17495% CI: [0.88, 2.06]Regression, Logistic
Comparison: The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.p-value: 0.09295% CI: [0.45, 1.06]Regression, Logistic
Secondary
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.
Time frame: Any use over assessments for years 1 or 2 of intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | 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 |
| Treatment as Usual (TAU) Cohort 1 | 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 |
| AD + CHW - Cohort 1 | 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 | 121 Participants |
| AD + CHW - Cohort 1 | 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 | 138 Participants |
| AD - Cohort 1 | 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 | 83 Participants |
| AD - Cohort 1 | 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 | 181 Participants |
| CHW - Cohort 2 | 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 | 27 Participants |
| CHW - Cohort 2 | 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 | 30 Participants |
| Treatment as Usual (TAU) Cohort 2 | 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 | 24 Participants |
| Treatment as Usual (TAU) Cohort 2 | 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 | 33 Participants |
Comparison: The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.p-value: <0.00195% CI: [1.34, 2.56]Regression, Logistic
Comparison: The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.p-value: 0.08495% CI: [0.46, 1.05]Regression, Logistic
Comparison: The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.p-value: 0.58995% CI: [0.59, 2.55]Regression, Logistic
Secondary
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.
Time frame: Any use over assessments for years 1 or 2 of intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 | Varenicline | 34 Participants |
| Treatment as Usual (TAU) Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 | No varenicline | 230 Participants |
| AD + CHW - Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 | Varenicline | 72 Participants |
| AD + CHW - Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 | No varenicline | 187 Participants |
| AD - Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 | Varenicline | 30 Participants |
| AD - Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 | No varenicline | 234 Participants |
Comparison: The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.p-value: <0.00195% CI: [1.61, 4.75]Regression, Logistic
Comparison: The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.p-value: 0.74295% CI: [0.5, 1.64]Regression, Logistic
Secondary
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.
Time frame: Any use over assessments for years 1 or 2 of intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment as Usual (TAU) Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Other | 230 Participants |
| Treatment as Usual (TAU) Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Varenicline | 34 Participants |
| AD + CHW - Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Varenicline | 72 Participants |
| AD + CHW - Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Other | 187 Participants |
| AD - Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Other | 234 Participants |
| AD - Cohort 1 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Varenicline | 30 Participants |
| CHW - Cohort 2 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Varenicline | 15 Participants |
| CHW - Cohort 2 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Other | 42 Participants |
| Treatment as Usual (TAU) Cohort 2 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Varenicline | 6 Participants |
| Treatment as Usual (TAU) Cohort 2 | Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 | Other | 51 Participants |
Comparison: The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.p-value: <0.00195% CI: [1.99, 4.68]Regression, Logistic
Comparison: The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.p-value: 0.69895% CI: [0.51, 1.57]Regression, Logistic
Comparison: The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.p-value: 0.84595% CI: [0.43, 2.78]Regression, Logistic