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Electronic Decision Support Systems for Smokers With Severe Mental Illness

Electronic Decision Support Systems for Smokers With Severe Mental Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01412866
Enrollment
124
Registered
2011-08-09
Start date
2011-05-31
Completion date
2012-05-31
Last updated
2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Schizophrenia, Severe Mental Illness, Tobacco Use Disorder

Keywords

schizophrenia, severe mental illness, nicotine, smoking, motivation, electronic decision support system, motivational interviewing

Brief summary

This randomized clinical trial among SMI smokers assessed whether the EDSS with carbon monoxide monitor and health-checklist feedback lead to higher rates of initiation of smoking cessation treatment, days of smoking abstinence and Fagerstrom Dependence scores, compared to use of the EDSS with checklist feedback alone.

Detailed description

Up to 80% of Americans with serious mental illnesses (SMI; schizophrenia and severe mood disorders) smoke cigarettes, and most suffer related health consequences. Although combined treatment with medication and psychosocial therapy can help people with SMI to quit smoking, it is rarely used. Motivational interventions can enhance the use of combined treatment, but motivational interventions are expensive and unavailable. To fill this gap, Dartmouth and Thresholds investigators have developed an easy-to-use, web-based electronic decision support system (EDSS) that aims to educate and motivate smokers with SMI. Preliminary testing has demonstrated excellent usability and increased engagement in smoking cessation treatments. One critical issue is the use of personalized health feedback. Motivational interventions for smoking cessation for smokers with SMI, including our EDSS, have included personal feedback from a breath monitor that measures carbon monoxide, a toxic component of cigarette smoke. Feedback regarding carbon monoxide is thought to motivate the user by personalizing the health risks of smoking. The carbon monoxide monitor is, however, expensive, difficult to implement, and largely unavailable in public mental health and primary care clinics. Further, research on use of carbon monoxide monitoring in the general population is equivocal. Another motivational strategy to personalize the negative health effects of smoking is a health checklist with feedback. Health checklists have been shown to be effective, are easy to use, have no expense, but have not been assessed separately from carbon monoxide monitor feedback among SMI smokers. Testing the effect of feedback from the health checklist compared to feedback from the carbon monoxide monitor is an essential next step in the development of this tool. Aim 1. The investigators propose a randomized clinical trial among SMI smokers to assess whether the EDSS with carbon monoxide monitor and health-checklist feedback will lead to higher rates of initiation of smoking cessation treatment than the EDSS with health-checklist feedback alone. Aim 1.a. To explore whether use of the EDSS with carbon monoxide monitor and health-checklist feedback leads to higher rates of the distal outcomes, days of smoking abstinence and Fagerstrom Dependence scores, than use of the EDSS with checklist feedback alone.

Interventions

BEHAVIORALEDSS with CO feedback and health checklist

Web-based electronic decision support system with CO feedback and health-checklist

BEHAVIORALEDSS with health checklist feedback alon

Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)

Sponsors

U.S. Department of Education
CollaboratorFED
Bristol-Myers Squibb
CollaboratorINDUSTRY
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* adult age 18-75 * in treatment for severe mental illness, * current smoker, * physically able to use a computer

Exclusion criteria

* Using smoking cessation treatment in past month, * substance dependence with current use

Design outcomes

Primary

MeasureTime frameDescription
Initiation of Smoking Cessation Treatment2 monthsStarted smoking cessation treatment

Secondary

MeasureTime frame
Days of Nicotine Abstinence6 months

Countries

United States

Participant flow

Participants by arm

ArmCount
EDSS With CO Monitor Feedback
Electronic decision support system with CO monitor feedback: Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist
58
EDSS Without CO Monitor Feedback
Electronic decision support system without CO monitor feedback: Web-based electronic decision support system (EDSS) with health-checklist feedback alone
66
Total124

Baseline characteristics

CharacteristicEDSS With CO Monitor FeedbackEDSS Without CO Monitor FeedbackTotal
Age, Continuous46.7 years
STANDARD_DEVIATION 9.3
46.3 years
STANDARD_DEVIATION 10.8
46.5 years
STANDARD_DEVIATION 10.1
Cigarettes smoked per day15.0 Cigarettes
STANDARD_DEVIATION 11.8
15.1 Cigarettes
STANDARD_DEVIATION 10.8
15.0 Cigarettes
STANDARD_DEVIATION 11.2
Race/Ethnicity, Customized
African American
30 Participants30 Participants60 Participants
Race/Ethnicity, Customized
Caucasian
26 Participants16 Participants42 Participants
Race/Ethnicity, Customized
Hispanic
6 Participants12 Participants18 Participants
Sex: Female, Male
Female
14 Participants21 Participants35 Participants
Sex: Female, Male
Male
44 Participants45 Participants89 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 580 / 66
serious
Total, serious adverse events
0 / 580 / 66

Outcome results

Primary

Initiation of Smoking Cessation Treatment

Started smoking cessation treatment

Time frame: 2 months

ArmMeasureValue (NUMBER)
EDSS With CO Monitor FeedbackInitiation of Smoking Cessation Treatment14 participants
EDSS Without CO Monitor FeedbackInitiation of Smoking Cessation Treatment24 participants
p-value: 0.08Chi-squared
Secondary

Days of Nicotine Abstinence

Time frame: 6 months

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026