Trial Outcomes & Findings for Electronic Decision Support Systems for Smokers With Severe Mental Illness (NCT NCT01412866)

Results Overview

Started smoking cessation treatment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

124 participants

Primary outcome timeframe

2 months

Results posted on

2018-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	EDSS With CO Monitor Feedback Electronic decision support system with carbon monoxide (CO) monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist	EDSS Without CO Monitor Feedback Electronic decision support system without carbon monoxide (CO) monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone
Overall Study STARTED	58	66
Overall Study COMPLETED	57	64
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electronic Decision Support Systems for Smokers With Severe Mental Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EDSS With CO Monitor Feedback n=58 Participants Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist	EDSS Without CO Monitor Feedback n=66 Participants Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone	Total n=124 Participants Total of all reporting groups
Age, Continuous	46.7 years STANDARD_DEVIATION 9.3 • n=5 Participants	46.3 years STANDARD_DEVIATION 10.8 • n=7 Participants	46.5 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants
Race/Ethnicity, Customized African American	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	26 Participants n=5 Participants	16 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Cigarettes smoked per day	15.0 Cigarettes STANDARD_DEVIATION 11.8 • n=5 Participants	15.1 Cigarettes STANDARD_DEVIATION 10.8 • n=7 Participants	15.0 Cigarettes STANDARD_DEVIATION 11.2 • n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Started smoking cessation treatment

Outcome measures

Outcome measures
Measure	EDSS With CO Monitor Feedback n=58 Participants Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist	EDSS Without CO Monitor Feedback n=66 Participants Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone
Initiation of Smoking Cessation Treatment	14 participants	24 participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

EDSS With CO Monitor Feedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EDSS Without CO Monitor Feedback

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

DArtmouth-Hitchcock

Phone: 603-27105747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place