Electronic Decision Support Systems for Smokers With Severe Mental Illness
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|ClinicalTrials.gov Identifier: NCT01412866|
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : September 28, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Mental Illness Nicotine Dependence||Behavioral: Electronic decision support system with CO monitor feedback Behavioral: Electronic decision support system without CO monitor feedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|Active Comparator: EDSS with CO monitor feedback||
Behavioral: Electronic decision support system with CO monitor feedback
Web-based electronic decision support system (EDSS) with carbon monoxide monitor and health-checklist
|Experimental: EDSS without CO monitor feedback||
Behavioral: 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 [ Time Frame: 2 months ]
- Days of nicotine abstinence [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412866
|United States, Illinois|
|Thresholds Psychiatric Rehabilitation Center|
|Chicago, Illinois, United States|
|Principal Investigator:||Mary F Brunette, MD||Dartmouth-Hitchcock Medical Center|