Electronic Decision Support Systems for Smokers With Severe Mental Illness

NCT ID: NCT01412866

Last Updated: 2018-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-05-31

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.

Conditions

Severe Mental Illness; Nicotine Dependence; Schizophrenia; Tobacco Use Disorder

Keywords

schizophrenia; severe mental illness; nicotine; smoking; motivation; electronic decision support system; motivational interviewing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EDSS with CO monitor

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

Group Type: EXPERIMENTAL

EDSS with CO feedback and health checklist

Intervention Type: BEHAVIORAL

Web-based electronic decision support system with CO feedback and health-checklist

EDSS without CO monitor

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

Group Type: ACTIVE_COMPARATOR

EDSS with health checklist feedback alon

Intervention Type: BEHAVIORAL

Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)

Interventions

EDSS with CO feedback and health checklist

Web-based electronic decision support system with CO feedback and health-checklist

Intervention Type: BEHAVIORAL

EDSS with health checklist feedback alon

Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mary F. Brunette, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary F Brunette, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Thresholds Psychiatric Rehabilitation Center

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21459986 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26932324 (View on PubMed)

Other Identifiers

EDSS1

Identifier Type: -

Identifier Source: org_study_id