Trial Outcomes & Findings for Reducing Tobacco Use Disparities Among Low-Income Adults (NCT NCT03077737)
NCT ID: NCT03077737
Last Updated: 2022-01-21
Results Overview
The number of participants who accepted the quitline call and accepted treatment as defined by enrolling in treatment and completing the first counseling session. Participants who returned a quitline call, enrolled in treatment, and completed the first counseling session were also counted as having engaged in treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
190 participants
Primary outcome timeframe
Week 6
Results posted on
2022-01-21
Participant Flow
Participant milestones
| Measure |
Population Health Management
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy).
|
Enhanced Usual Care
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit.
|
|---|---|---|
|
Week 6 (10 Weeks After Enrollment)
STARTED
|
97
|
93
|
|
Week 6 (10 Weeks After Enrollment)
COMPLETED
|
89
|
79
|
|
Week 6 (10 Weeks After Enrollment)
NOT COMPLETED
|
8
|
14
|
|
Week 14 (18 Weeks After Enrollment)
STARTED
|
97
|
93
|
|
Week 14 (18 Weeks After Enrollment)
COMPLETED
|
83
|
76
|
|
Week 14 (18 Weeks After Enrollment)
NOT COMPLETED
|
14
|
17
|
|
Week 28 (32 Weeks After Enrollment)
STARTED
|
49
|
47
|
|
Week 28 (32 Weeks After Enrollment)
COMPLETED
|
39
|
40
|
|
Week 28 (32 Weeks After Enrollment)
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Tobacco Use Disparities Among Low-Income Adults
Baseline characteristics by cohort
| Measure |
Population Health Management
n=97 Participants
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy).
|
Enhanced Usual Care
n=93 Participants
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
48.8 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
49.0 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex/Gender, Customized
Females
|
58 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Males
|
49 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
81 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6The number of participants who accepted the quitline call and accepted treatment as defined by enrolling in treatment and completing the first counseling session. Participants who returned a quitline call, enrolled in treatment, and completed the first counseling session were also counted as having engaged in treatment.
Outcome measures
| Measure |
Population Health Management
n=97 Participants
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy).
|
Enhanced Usual Care
n=93 Participants
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit.
|
|---|---|---|
|
Quitline Treatment Engagement
|
25 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 14The number of participants who completed one or more additional quitline counseling calls.
Outcome measures
| Measure |
Population Health Management
n=97 Participants
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy).
|
Enhanced Usual Care
n=93 Participants
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit.
|
|---|---|---|
|
Quitline Treatment Utilization
|
21 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 28Population: Due to project timeline constraints, only the first 96 participants were followed for 32 weeks.
Self-reported seven-day point-prevalence abstinence at week 28. Number of participants who reporting smoking cessation at week 28. Participants were classified as abstinent if they reported not smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.
Outcome measures
| Measure |
Population Health Management
n=49 Participants
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy).
|
Enhanced Usual Care
n=47 Participants
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit.
|
|---|---|---|
|
Smoking Cessation at Week 28 (32 Weeks After Enrollment)
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 14Self-reported seven-day point-prevalence abstinence at week 14. Participants were classified as abstinent if they reported not smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.
Outcome measures
| Measure |
Population Health Management
n=97 Participants
Population health management for smoking cessation in low-income smokers: the Choose to Change intervention
Choose to Change: Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy).
|
Enhanced Usual Care
n=93 Participants
Usual clinic-based care enhanced by an EHR system that can deliver an electronic referral for quitline treatment
Enhanced usual care: Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit.
|
|---|---|---|
|
Smoking Cessation at Week 14 (18 Weeks After Enrollment)
|
9 Participants
|
3 Participants
|
Adverse Events
Population Health Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place