Electronic Decision Support Systems for Smokers With Severe Mental Illness
Primary Purpose
Severe Mental Illness, Nicotine Dependence, Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EDSS with CO feedback and health checklist
EDSS with health checklist feedback alon
Sponsored by
About this trial
This is an interventional treatment trial for Severe Mental Illness focused on measuring schizophrenia, severe mental illness, nicotine, smoking, motivation, electronic decision support system, motivational interviewing
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
Sites / Locations
- Thresholds Psychiatric Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EDSS with CO monitor
EDSS without CO monitor
Arm Description
Web-based electronic decision support system (EDSS) with carbon monoxide (CO) monitor and health-checklist
Web-based electronic decision support system (EDSS) with health-checklist only
Outcomes
Primary Outcome Measures
Initiation of Smoking Cessation Treatment
Started smoking cessation treatment
Secondary Outcome Measures
Days of Nicotine Abstinence
Full Information
NCT ID
NCT01412866
First Posted
August 4, 2011
Last Updated
December 11, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
U.S. Department of Education, Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01412866
Brief Title
Electronic Decision Support Systems for Smokers With Severe Mental Illness
Official Title
Electronic Decision Support Systems for Smokers With Severe Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
U.S. Department of Education, Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Mental Illness, Nicotine Dependence, Schizophrenia, Tobacco Use Disorder
Keywords
schizophrenia, severe mental illness, nicotine, smoking, motivation, electronic decision support system, motivational interviewing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDSS with CO monitor
Arm Type
Experimental
Arm Description
Web-based electronic decision support system (EDSS) with carbon monoxide (CO) monitor and health-checklist
Arm Title
EDSS without CO monitor
Arm Type
Active Comparator
Arm Description
Web-based electronic decision support system (EDSS) with health-checklist only
Intervention Type
Behavioral
Intervention Name(s)
EDSS with CO feedback and health checklist
Intervention Description
Web-based electronic decision support system with CO feedback and health-checklist
Intervention Type
Behavioral
Intervention Name(s)
EDSS with health checklist feedback alon
Intervention Description
Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)
Primary Outcome Measure Information:
Title
Initiation of Smoking Cessation Treatment
Description
Started smoking cessation treatment
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Days of Nicotine Abstinence
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary F Brunette, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thresholds Psychiatric Rehabilitation Center
City
Chicago
State/Province
Illinois
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21459986
Citation
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.
Results Reference
background
PubMed Identifier
26932324
Citation
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.
Results Reference
derived
Learn more about this trial
Electronic Decision Support Systems for Smokers With Severe Mental Illness
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