Trial Outcomes & Findings for Implementation Science to Reduce the Disparity in Tobacco Treatment Among Individuals With Serious Mental Illness (NCT NCT05952401)
NCT ID: NCT05952401
Last Updated: 2026-03-10
Results Overview
This will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling).
COMPLETED
NA
59 participants
At 3 months
2026-03-10
Participant Flow
The study opened to participant enrollment on 02/02/2024 and closed to participant enrollment on 09/27/2024.
The study consented 73 participants and 14 were excluded after consenting due to loss of contact or not meeting all eligibility criteria prior to randomization. 59 were considered enrolled and 14 were not considered enrolled in the study per the policy of the institution.
Participant milestones
| Measure |
Usual Care
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Usual Care
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
Baseline Characteristics
Implementation Science to Reduce the Disparity in Tobacco Treatment Among Individuals With Serious Mental Illness
Baseline characteristics by cohort
| Measure |
Usual Care
n=30 Participants
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
n=29 Participants
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
24-40 years
|
6 Participants
n=68 Participants
|
10 Participants
n=69 Participants
|
16 Participants
n=137 Participants
|
|
Age, Customized
41-46 years
|
11 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
14 Participants
n=137 Participants
|
|
Age, Customized
47-59 years
|
5 Participants
n=68 Participants
|
9 Participants
n=69 Participants
|
14 Participants
n=137 Participants
|
|
Age, Customized
60-72 years
|
8 Participants
n=68 Participants
|
7 Participants
n=69 Participants
|
15 Participants
n=137 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=68 Participants
|
14 Participants
n=69 Participants
|
31 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=68 Participants
|
15 Participants
n=69 Participants
|
28 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=68 Participants
|
27 Participants
n=69 Participants
|
55 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=68 Participants
|
11 Participants
n=69 Participants
|
27 Participants
n=137 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=68 Participants
|
14 Participants
n=69 Participants
|
26 Participants
n=137 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=68 Participants
|
29 participants
n=69 Participants
|
59 participants
n=137 Participants
|
PRIMARY outcome
Timeframe: At 3 monthsThis will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling).
Outcome measures
| Measure |
Usual Care
n=30 Participants
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
n=29 Participants
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Proportion of Patients Receiving Any Tobacco Treatment
Received treatment
|
18 Participants
|
23 Participants
|
|
Proportion of Patients Receiving Any Tobacco Treatment
Did not receive treatment
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At 6 monthsThis will be quantified by the proportion of patients who receive any tobacco treatment (medication and/or counseling).
Outcome measures
| Measure |
Usual Care
n=30 Participants
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
n=29 Participants
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Proportion of Patients Receiving Any Tobacco Treatment
Received treatment
|
18 Participants
|
26 Participants
|
|
Proportion of Patients Receiving Any Tobacco Treatment
Did not receive treatment
|
12 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At 3 months and 6 monthsPopulation: The participants are not included in the number analyzed if the participants missed responding at the specified time point.
\- This will be quantified by the proportion of current smokers in the stage of change classifications of Precontemplation, Contemplation, Preparation, or Action. * Precontemplation Stage: The participant is not seriously considering quitting within the next 6 months. * Contemplation Stage: The participant is seriously considering quitting within the next 6 months. * Preparation Stage: The participant is planning to quit within the next 30 days. * Action Stage: The participant quit smoking within the last 6 months or quit smoking more than 6 months.
Outcome measures
| Measure |
Usual Care
n=26 Participants
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
n=28 Participants
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Readiness to Quit Smoking
3 months · Preparation Stage
|
3 Participants
|
1 Participants
|
|
Readiness to Quit Smoking
3 months · Precontemplation Stage
|
9 Participants
|
12 Participants
|
|
Readiness to Quit Smoking
3 months · Contemplation Stage
|
10 Participants
|
11 Participants
|
|
Readiness to Quit Smoking
3 months · Action Stage
|
3 Participants
|
2 Participants
|
|
Readiness to Quit Smoking
6 months · Precontemplation Stage
|
5 Participants
|
7 Participants
|
|
Readiness to Quit Smoking
6 months · Contemplation Stage
|
12 Participants
|
14 Participants
|
|
Readiness to Quit Smoking
6 months · Preparation Stage
|
5 Participants
|
2 Participants
|
|
Readiness to Quit Smoking
6 months · Action Stage
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 months post interventionThis will be quantified by the proportion of smokers with bioverified point prevalence abstinence smoking abstinence at 3 months.
Outcome measures
| Measure |
Usual Care
n=30 Participants
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
n=29 Participants
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Smoking Abstinence
Self-Reported Smoking Abstinence, but did not Achieve Bioverified Smoking Abstinence (<5ppm)
|
3 Participants
|
0 Participants
|
|
Smoking Abstinence
Did not Self-Report Smoking Abstinence and did not Achieve Bioverified Smoking Abstinence (<5ppm)
|
27 Participants
|
29 Participants
|
|
Smoking Abstinence
Achieved Smoking Abstinence (<5ppm)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 3 months and 6 monthsThe outcome measure is abstinence (self-reported no smoking (not even a puff of a cigarette) for at least seven days prior to the assessment) over these time points.
Outcome measures
| Measure |
Usual Care
n=30 Participants
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
n=29 Participants
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Abstinence Outcomes Across Time Points
3 months · Reported Abstinence
|
3 Participants
|
0 Participants
|
|
Abstinence Outcomes Across Time Points
3 months · Did not Report Abstinence
|
27 Participants
|
29 Participants
|
|
Abstinence Outcomes Across Time Points
6 months · Reported Abstinence
|
5 Participants
|
4 Participants
|
|
Abstinence Outcomes Across Time Points
6 months · Did not Report Abstinence
|
25 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: At 3 months and 6 monthsPopulation: The participants are not included in the number analyzed if the participants missed responding at the specified time point.
The outcome measure is smoking quantity (self-reported average cigarettes smoked per day for the past 30 days prior to the assessment) over these time points.
Outcome measures
| Measure |
Usual Care
n=26 Participants
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
n=28 Participants
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Smoking Quantity Across Multiple Time Points
3 months
|
9.93 cigarettes per day
Standard Error 1.44
|
11.18 cigarettes per day
Standard Error 1.50
|
|
Smoking Quantity Across Multiple Time Points
6 months
|
10.63 cigarettes per day
Standard Error 1.69
|
9.59 cigarettes per day
Standard Error 1.41
|
SECONDARY outcome
Timeframe: At 3 months and 6 monthsPopulation: The participants are not included in the number analyzed if the participants missed responding at the specified time point.
This outcome measure is the number of quit attempts over these time points.
Outcome measures
| Measure |
Usual Care
n=26 Participants
Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.
|
"Nudges to Quit"
n=28 Participants
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Quit Attempts
3 months
|
0.40 quit attempts
Standard Error 0.24
|
0.69 quit attempts
Standard Error 0.27
|
|
Quit Attempts
6 months
|
0.35 quit attempts
Standard Error 0.14
|
0.93 quit attempts
Standard Error 0.82
|
Adverse Events
Usual Care
"Nudges to Quit"
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Li-Shiun Chen, M.D., MPH, ScD
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place