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: 2025-12-16
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
2025-12-16
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=6 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=5 Participants
|
|
Age, Customized
41-46 years
|
11 Participants
n=6 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=5 Participants
|
|
Age, Customized
47-59 years
|
5 Participants
n=6 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=5 Participants
|
|
Age, Customized
60-72 years
|
8 Participants
n=6 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=6 Participants
|
14 Participants
n=5 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=6 Participants
|
15 Participants
n=5 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=6 Participants
|
27 Participants
n=5 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=6 Participants
|
11 Participants
n=5 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=6 Participants
|
14 Participants
n=5 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=6 Participants
|
29 participants
n=5 Participants
|
59 participants
n=5 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
Outcome data not reported
SECONDARY outcome
Timeframe: At 3 months, 6 monthsThis will be quantified by the proportion of current smokers in the stage of change classifications of Precontemplation, Contemplation, Preparation, or Action.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post interventionPopulation: 5 participants from the Usual Care arm and 3 participants from the "Nudges to Quit" arm are not included because the participants did not complete the 3-month assessment.
This will be quantified by the proportion of smokers with bioverified point prevalence abstinence smoking abstinence at 3 months.
Outcome measures
| Measure |
Usual Care
n=25 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=26 Participants
Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.
|
|---|---|---|
|
Smoking Abstinence
Achieved Smoking Abstinence (<5ppm)
|
0 Participants
|
0 Participants
|
|
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)
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: At 3 months, 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
Outcome data not reported
SECONDARY outcome
Timeframe: At 3 months, 6 monthsThe 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
Outcome data not reported
SECONDARY outcome
Timeframe: At 3 months, 6 monthsThis outcome measure is the number of quit attempts over these time points.
Outcome measures
Outcome data not reported
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