Trial Outcomes & Findings for Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness (NCT NCT01779440)

NCT ID: NCT01779440

Last Updated: 2018-06-27

Results Overview

Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: 14 week follow-up
• Results posted on: 2018-06-27

Participant Flow

Participant milestones

Measure	Electronic Decision Support System The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment. Electronic Decision Support System	Control Computer Program A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System
Overall Study STARTED	30	28
Overall Study COMPLETED	27	23
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Electronic Decision Support System The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment. Electronic Decision Support System	Control Computer Program A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System
Overall Study Withdrawal by Subject	3	5

Baseline Characteristics

Decision Support for Smoking Cessation in Young Adults With Severe Mental Illness

Baseline characteristics by cohort

Measure	Electronic Decision Support System n=30 Participants The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment. Electronic Decision Support System	Control Computer Program n=28 Participants A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System	Total n=58 Participants Total of all reporting groups
Age, Continuous	23.5 years STANDARD_DEVIATION 3.9 • n=5 Participants	25.0 years STANDARD_DEVIATION 3.2 • n=7 Participants	24.2 years STANDARD_DEVIATION 3.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized African American	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Other race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Mean cigarettes per day	10.9 cigarettes STANDARD_DEVIATION 8.6 • n=5 Participants	13.9 cigarettes STANDARD_DEVIATION 9.4 • n=7 Participants	12.3 cigarettes STANDARD_DEVIATION 9.0 • n=5 Participants

PRIMARY outcome

Timeframe: 14 week follow-up

Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.

Outcome measures

Measure	Electronic Decision Support System n=27 Participants The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment. Electronic Decision Support System	Control Computer Program n=23 Participants A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System
Number of Participants Who Utilized Smoking Cessation Treatment	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 weeks

Population: Participants who attended the follow-up assessment

Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide <9 ppm

Outcome measures

Measure	Electronic Decision Support System n=27 Participants The Electronic Decision Support System is a web-based computer program designed to motivate, educate, and engage people with severe mental illness into evidence-based smoking cessation treatment. Electronic Decision Support System	Control Computer Program n=23 Participants A computer program aimed to educate people about smoking cessation treatment. Electronic Decision Support System
Number of Participants With Biologically Confirmed Abstinence	4 Participants	0 Participants

Adverse Events

Electronic Decision Support System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Computer Program

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

Mary F. Brunette, MD

Dartmouth-Hitchcock

Phone: 603-229-5419

Email: Mary.F.Brunette@hitchcock.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place