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Clinical Trials/NCT01412866
NCT01412866CompletedNot Applicable

Electronic Decision Support Systems for Smokers With Severe Mental Illness

Dartmouth-Hitchcock Medical Center1 site in 1 country124 target enrollmentStarted: May 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
124
Locations
1
Primary Endpoint
Initiation of Smoking Cessation Treatment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

EDSS with CO monitor

Experimental

Web-based electronic decision support system (EDSS) with carbon monoxide (CO) monitor and health-checklist

Intervention: EDSS with CO feedback and health checklist (Behavioral)

EDSS without CO monitor

Active Comparator

Web-based electronic decision support system (EDSS) with health-checklist only

Intervention: EDSS with health checklist feedback alon (Behavioral)

Outcomes

Primary Outcomes

Initiation of Smoking Cessation Treatment

Time Frame: 2 months

Started smoking cessation treatment

Secondary Outcomes

  • Days of Nicotine Abstinence(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mary F. Brunette, MD

MD

Dartmouth-Hitchcock Medical Center

Study Sites (1)

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