Trial Outcomes & Findings for Proactive Outreach for Smoking Treatment (NCT NCT04988477)
NCT ID: NCT04988477
Last Updated: 2025-12-08
Results Overview
number of participants who reported 7-day point prevalence smoking abstinence (no smoking past 7 days) and a expired air CO value of \<6ppm in study 3 only
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
1 year post baseline
Results posted on
2025-12-08
Participant Flow
Participant milestones
| Measure |
Study 3
This is a single arm pre-post trial.
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
Study 1
Single Interview regarding feasibility and acceptability of delivering chronic care management for smoking cessation in community mental health centers
|
Study 2
Quarterly brief provider interventions and a single proactive outreach call to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: brief provider intervention (the 5As) quarterly over 3 months and one outreach call over 3 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
25
|
20
|
|
Overall Study
COMPLETED
|
41
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
0
|
Reasons for withdrawal
| Measure |
Study 3
This is a single arm pre-post trial.
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
Study 1
Single Interview regarding feasibility and acceptability of delivering chronic care management for smoking cessation in community mental health centers
|
Study 2
Quarterly brief provider interventions and a single proactive outreach call to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: brief provider intervention (the 5As) quarterly over 3 months and one outreach call over 3 months.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
Demographics were not collected in Study 1; age only collected for 48 patients in study 3
Baseline characteristics by cohort
| Measure |
Study 3
n=49 Participants
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
Study 2
n=25 Participants
Quarterly brief provider interventions and a single proactive outreach call to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: brief provider intervention (the 5As) quarterly over 3 months and one outreach call over 3 months.
|
Study 1
n=20 Participants
Single interview regarding feasibility and acceptability of delivering chronic care management for smoking cessation in community mental health centers.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.23 years
STANDARD_DEVIATION 11.88 • n=48 Participants • Demographics were not collected in Study 1; age only collected for 48 patients in study 3
|
48.64 years
STANDARD_DEVIATION 12.14 • n=25 Participants • Demographics were not collected in Study 1; age only collected for 48 patients in study 3
|
—
|
43.93 years
STANDARD_DEVIATION 12.37 • n=73 Participants • Demographics were not collected in Study 1; age only collected for 48 patients in study 3
|
|
Sex: Female, Male
Female
|
32 Participants
n=49 Participants • Demographics were not collected in study 1
|
17 Participants
n=25 Participants • Demographics were not collected in study 1
|
—
|
49 Participants
n=74 Participants • Demographics were not collected in study 1
|
|
Sex: Female, Male
Male
|
17 Participants
n=49 Participants • Demographics were not collected in study 1
|
8 Participants
n=25 Participants • Demographics were not collected in study 1
|
—
|
25 Participants
n=74 Participants • Demographics were not collected in study 1
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=49 Participants • Demographics were not collected in Study 1
|
0 Participants
n=25 Participants • Demographics were not collected in Study 1
|
—
|
0 Participants
n=74 Participants • Demographics were not collected in Study 1
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=49 Participants • Demographics were not collected in Study 1
|
25 Participants
n=25 Participants • Demographics were not collected in Study 1
|
—
|
74 Participants
n=74 Participants • Demographics were not collected in Study 1
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants • Demographics were not collected in Study 1
|
0 Participants
n=25 Participants • Demographics were not collected in Study 1
|
—
|
0 Participants
n=74 Participants • Demographics were not collected in Study 1
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=49 Participants • demographics were not collected in Study 1
|
2 Participants
n=25 Participants • demographics were not collected in Study 1
|
—
|
3 Participants
n=74 Participants • demographics were not collected in Study 1
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=49 Participants • demographics were not collected in Study 1
|
0 Participants
n=25 Participants • demographics were not collected in Study 1
|
—
|
0 Participants
n=74 Participants • demographics were not collected in Study 1
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants • demographics were not collected in Study 1
|
0 Participants
n=25 Participants • demographics were not collected in Study 1
|
—
|
0 Participants
n=74 Participants • demographics were not collected in Study 1
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=49 Participants • demographics were not collected in Study 1
|
1 Participants
n=25 Participants • demographics were not collected in Study 1
|
—
|
4 Participants
n=74 Participants • demographics were not collected in Study 1
|
|
Race (NIH/OMB)
White
|
44 Participants
n=49 Participants • demographics were not collected in Study 1
|
22 Participants
n=25 Participants • demographics were not collected in Study 1
|
—
|
66 Participants
n=74 Participants • demographics were not collected in Study 1
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=49 Participants • demographics were not collected in Study 1
|
0 Participants
n=25 Participants • demographics were not collected in Study 1
|
—
|
1 Participants
n=74 Participants • demographics were not collected in Study 1
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants • demographics were not collected in Study 1
|
0 Participants
n=25 Participants • demographics were not collected in Study 1
|
—
|
0 Participants
n=74 Participants • demographics were not collected in Study 1
|
|
Region of Enrollment
United States
|
49 Participants
n=49 Participants
|
25 Participants
n=25 Participants
|
20 Participants
n=20 Participants
|
94 Participants
n=94 Participants
|
|
cigarettes per day
|
15.35 cigarettes per day
STANDARD_DEVIATION 8.97 • n=49 Participants • Cigarettes per day was not collected in Study 1
|
16.67 cigarettes per day
STANDARD_DEVIATION 10.07 • n=25 Participants • Cigarettes per day was not collected in Study 1
|
—
|
15.92 cigarettes per day
STANDARD_DEVIATION 9.30 • n=74 Participants • Cigarettes per day was not collected in Study 1
|
PRIMARY outcome
Timeframe: 1 year post baselinePopulation: Participants who completed baseline data and were alive at follow-up (1 participant died and so data was not analyzed)
number of participants who reported 7-day point prevalence smoking abstinence (no smoking past 7 days) and a expired air CO value of \<6ppm in study 3 only
Outcome measures
| Measure |
Study 1
n=48 Participants
Participants were interviewed about current smoking cessation practices in their organization and feasibility and acceptability of planned study interventions
|
Study 3
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
|---|---|---|
|
Study 3: Smoking Abstinence
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: interview (up to 30 minutes at study visit)Population: Interview participants including patients, providers, and leaders at community mental health centers
Number of participants who reported the proposed intervention was feasible
Outcome measures
| Measure |
Study 1
n=20 Participants
Participants were interviewed about current smoking cessation practices in their organization and feasibility and acceptability of planned study interventions
|
Study 3
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
|---|---|---|
|
Study 1: Perceived Feasibility of Intervention
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: interview (up to 30 minutes at study visit)Population: patients, providers, and leaders at a community mental healthcare center
number of participants who agreed the proposed intervention was acceptable.
Outcome measures
| Measure |
Study 1
n=20 Participants
Participants were interviewed about current smoking cessation practices in their organization and feasibility and acceptability of planned study interventions
|
Study 3
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
|---|---|---|
|
Study 1: Perceived Acceptability of Intervention
|
18 Participants
|
—
|
PRIMARY outcome
Timeframe: baselinePopulation: patients in a community mental healthcare center who smoke cigarettes
Number of participants recruited (goal for study 2=25; goal for study 3=50)
Outcome measures
| Measure |
Study 1
n=25 Participants
Participants were interviewed about current smoking cessation practices in their organization and feasibility and acceptability of planned study interventions
|
Study 3
n=49 Participants
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
|---|---|---|
|
Studies 2 & 3: Feasibility of Recruitment
|
25 Participants
|
49 Participants
|
PRIMARY outcome
Timeframe: 3 months post enrollmentPopulation: This measure was the primary outcome of the chronic care for tobacco use (study 3) and the pilot trial (study 2) only. The recruitment target for study 2 was 25, the recruitment target for study 3 was 50.
% of participants completing follow-up in studies 2 \& 3
Outcome measures
| Measure |
Study 1
n=49 Participants
Participants were interviewed about current smoking cessation practices in their organization and feasibility and acceptability of planned study interventions
|
Study 3
n=23 Participants
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
|---|---|---|
|
Studies 2 & 3: Feasibility of Retention
|
41 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 3 months post enrollmentPopulation: Patients and providers from a community mental health center who participated in the study
Number of participants who perceived that the intervention was acceptable drawn from qualitative reports of intervention acceptability from selected patients (N=5) and providers and leaders (N=4)
Outcome measures
| Measure |
Study 1
n=9 Participants
Participants were interviewed about current smoking cessation practices in their organization and feasibility and acceptability of planned study interventions
|
Study 3
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
|---|---|---|
|
Study 2: Perceived Acceptability of Intervention
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 year post baselinePopulation: Participants who completed baseline and were alive at the 12 month follow-up (1 participant died during the follow up period and so the did not contribute outcome data).
30 day prolonged abstinence (no smoking past 30 days prior to 1 year follow-up)
Outcome measures
| Measure |
Study 1
n=48 Participants
Participants were interviewed about current smoking cessation practices in their organization and feasibility and acceptability of planned study interventions
|
Study 3
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
|---|---|---|
|
Study 3: Smoking Abstinence
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 year post-baselinePopulation: Participants who completed baseline assessment.
Number of 24 hour intentional quit attempts
Outcome measures
| Measure |
Study 1
n=49 Participants
Participants were interviewed about current smoking cessation practices in their organization and feasibility and acceptability of planned study interventions
|
Study 3
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
|---|---|---|
|
Study 3: Quit Attempts
|
3.07 quit attempts
Standard Deviation 4.46
|
—
|
SECONDARY outcome
Timeframe: 12 months post baselinePopulation: participants who were alive at the 12 month follow-up (1 person died and so their data was not used)
number of cigarettes smoked per day in study 3
Outcome measures
| Measure |
Study 1
n=48 Participants
Participants were interviewed about current smoking cessation practices in their organization and feasibility and acceptability of planned study interventions
|
Study 3
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
|
|---|---|---|
|
Study 3: Cigarettes Per Day
|
10.56 cigarettes per day
Standard Deviation 12.02
|
—
|
Adverse Events
Study 3: Chronic care for tobacco use
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Study 2: Pilot trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study 1: Interview study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study 3: Chronic care for tobacco use
n=49 participants at risk
Quarterly brief provider interventions about tobacco and 3 quarterly proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
Chronic care management: Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 9 months.
|
Study 2: Pilot trial
n=25 participants at risk
Provider brief provider interventions about tobacco and 1 proactive outreach calls to connect patients to telephone cessation counseling and facilitate obtaining cessation medication.
|
Study 1: Interview study
n=20 participants at risk
patients, providers, and leaders were interviewed about study feasibility/acceptability
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Inpatient Hospitalization
|
2.0%
1/49 • Number of events 1 • 15 months
Adverse events were not systematically collected. However, if participants reported an adverse event or serious adverse event during follow-up phone calls it was documented. Additionally, if a participant was not available for follow-up due to a serious adverse event or death, that was recorded.
|
0.00%
0/25 • 15 months
Adverse events were not systematically collected. However, if participants reported an adverse event or serious adverse event during follow-up phone calls it was documented. Additionally, if a participant was not available for follow-up due to a serious adverse event or death, that was recorded.
|
0.00%
0/20 • 15 months
Adverse events were not systematically collected. However, if participants reported an adverse event or serious adverse event during follow-up phone calls it was documented. Additionally, if a participant was not available for follow-up due to a serious adverse event or death, that was recorded.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sandra Japuntich
Hennepin Healthcare Research Institute
Phone: 6128736856
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place