Electronic Decision Support Systems for Smokers With Severe Mental Illness

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Tobacco Use Disorder; Nicotine Dependence; Severe Mental Illness
• Intervention / Treatment: Behavioral: EDSS with CO feedback and health checklist; Behavioral: EDSS with health checklist feedback alon

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 Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States
      • Thresholds Psychiatric Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EDSS with CO monitor; Web-based electronic decision support system (EDSS) with carbon monoxide (CO) monitor and health-checklist	Behavioral: EDSS with CO feedback and health checklist; Web-based electronic decision support system with CO feedback and health-checklist
Active Comparator: EDSS without CO monitor; Web-based electronic decision support system (EDSS) with health-checklist only	Behavioral: EDSS with health checklist feedback alon; Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of Smoking Cessation Treatment	Started smoking cessation treatment	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Days of Nicotine Abstinence	6 months

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Bristol-Myers Squibb; U.S. Department of Education
• Investigators: Principal Investigator: Mary F Brunette, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• 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.
• Ferron JC, Devitt T, McHugo GJ, A Jonikas J, Cook JA, Brunette MF. Abstinence and Use of Community-Based Cessation Treatment After a Motivational Intervention Among smokers with Severe Mental Illness. Community Ment Health J. 2016 May;52(4):446-56. doi: 10.1007/s10597-016-9998-1. Epub 2016 Mar 1.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: August 4, 2011
• First Submitted That Met QC Criteria: August 8, 2011
• First Posted (Estimate): August 9, 2011

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: schizophrenia; smoking; severe mental illness; motivational interviewing; nicotine; motivation; electronic decision support system
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Mental Disorders; Tobacco Use Disorder
• Other Study ID Numbers: EDSS1