Electronic Decision Support Systems for Smokers With Severe Mental Illness

Schizophrenia Clinical Trial

Official title:

Electronic Decision Support Systems for Smokers With Severe Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412866
• Other study ID #: EDSS1
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Nicotine Dependence
• Schizophrenia
• Severe Mental Illness
• Tobacco Use Disorder

Intervention

Behavioral:
• EDSS with CO feedback and health checklist
Web-based electronic decision support system with CO feedback and health-checklist
• EDSS with health checklist feedback alon
Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)

Locations

Country	Name	City	State
United States	Thresholds Psychiatric Rehabilitation Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Bristol-Myers Squibb, U.S. Department of Education

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brunette MF, Ferron JC, McHugo GJ, Davis KE, Devitt TS, Wilkness SM, Drake RE. An electronic decision support system to motivate people with severe mental illnesses to quit smoking. Psychiatr Serv. 2011 Apr;62(4):360-6. doi: 10.1176/ps.62.4.pss6204_0360. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of Smoking Cessation Treatment	Started smoking cessation treatment	2 months
Secondary	Days of Nicotine Abstinence		6 months