Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
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. |
Assessment at end of year 2 of intervention |
|
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. |
Any use over assessments for years 1 or 2 of intervention |
|
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. |
Any use over assessments for years 1 or 2 of intervention |
|
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. |
Assessment at end of year 2 of intervention |
|
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. |
Assessment at end of year 2 of intervention |
|
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. |
Assessment at end of year 2 of intervention |
|
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. |
Any use over assessments for years 1 or 2 of intervention |
|
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. |
Any use over assessments for years 1 or 2 of intervention |
|
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. |
Assessment at end of year 2 of intervention |
|
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. |
Assessment at end of year 2 of intervention |
|
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. |
Assessment at end of year 2 of intervention |
|
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. |
Assessment at end of year 2 of intervention |
|