Electronic Decision Support Systems for Smokers With Severe Mental Illness

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.

Official Title
-----------------
Electronic Decision Support Systems for Smokers With Severe Mental Illness

Conditions
-----------------
Severe Mental Illness, Nicotine Dependence, Schizophrenia, Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: EDSS with CO feedback and health checklist
* Behavioral: EDSS with health checklist feedback alon


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 | Measure Description | Time Frame |
| --- | --- | --- |
| Days of Nicotine Abstinence |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, severe mental illness, nicotine, smoking, motivation, electronic decision support system, motivational interviewing