Electronic Decision Support Systems for Smokers With Severe Mental Illness

This study has been completed.
Sponsor:
Collaborators:
U.S. Department of Education
Bristol-Myers Squibb
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01412866
First received: August 4, 2011
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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 Intervention
Severe Mental Illness
Nicotine Dependence
Behavioral: Electronic decision support system with CO monitor feedback
Behavioral: Electronic decision support system without CO monitor feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Initiation of smoking cessation treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Days of nicotine abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412866

Locations
United States, Illinois
Thresholds Psychiatric Rehabilitation Center
Chicago, Illinois, United States
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
U.S. Department of Education
Bristol-Myers Squibb
Investigators
Principal Investigator: Mary F Brunette, MD Dartmouth-Hitchcock Medical Center
  More Information

Publications:
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01412866     History of Changes
Other Study ID Numbers: EDSS1
Study First Received: August 4, 2011
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
schizophrenia
severe mental illness
nicotine
smoking
motivation
electronic decision support system
motivational interviewing

Additional relevant MeSH terms:
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 26, 2014