Tobacco Cessation for Veterans With Post Traumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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The goal of this study is to improve the effectiveness of tobacco cessation treatment for veterans with Post Traumatic Stress Disorder (PTSD) through ongoing, integrated care management approach using telehealth and motivational interviewing counseling. Both tobacco dependence and PTSD represent enormous challenges to the Veterans Affairs (VA) healthcare system.

Detailed Description
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Background: Veterans smoke at a higher rate (30%) than the U.S. adult population (21%), and veterans with PTSD have even higher rates of smoking (53-66%). Evidence has shown that any tobacco dependence treatment strategy must be integrated in the health care system because consistent and effective delivery of tobacco cessation requires coordinated interventions. Persistent tobacco users typically cycle through multiple periods of relapse and remission. Veterans with PTSD (279,256 in 2005) who are treated for smoking cessation may need more comprehensive aid to be successful. Failure to appreciate the chronic nature of tobacco dependence may impede comprehensive and consistent treatment. Care management using telehealth has been shown to improve access to care while reducing costs for veterans with chronic diseases and has the potential to coordinate smoking cessation with care for other chronic diseases. Nurses have successfully managed chronic diseases using telehealth by focusing on increasing self-management, positive behaviors and knowledge. Nurses are vital to increasing the level of support in the community through education and motivation and by responding to medical events in order to improve veterans' health. Objectives: The study is designed to determine if adding motivational counseling and care management using the PTSD Health Buddy to usual care improves smoking quit rates of veterans with PTSD. Specific Aims are to compare: 1) self-reported quit attempts, progression through the stages of change, and quit rates, 2) patient perception of care coordination, and 3) changes in PTSD symptoms in veteran smokers with PTSD who receive a nurse-driven telephonic motivational counseling intervention triggered by responses to stage-based smoking cessation questions in addition to usual care to those who receive usual care only.

Official Title
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Telehealth Care Management and Tobacco Cessation for Veterans With PTSD

Conditions
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Tobacco Use Cessation, Post Traumatic Stress Disorders

Intervention / Treatment
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* Behavioral: Motivation Interviewing Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders IV criteria (DSM-IV) for diagnosis code 309.81 PTSD Willingness to participate Currently smoking 1 or more cigarettes per day Exclusion Criteria: Use smokeless tobacco, pipes or cigars instead of cigarettes Have imminent risk of suicide or violence Have severe psychiatric symptoms or psychosocial instability likely to prevent participation in protocol (provider will assess appropriateness) Have clinically apparent gross cognitive impairment Unable to connect Health Buddy in home

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced PTSD Health Buddy and Motivational Interviewing<br>Veterans with PTSD who smoke are exposed to an intervention which included a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care | Behavioral: Motivation Interviewing Counseling<br>* Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions<br>|
| No Intervention: Usual PTSD Health Buddy Care<br>Veteran with PTSD who smoke randomly assigned to this arm received standard of care for smoking cessation and used the standard PTSD Health Buddy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). |  | During 90-session intervention period | 
| Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. | Transtheoretical Model of Change questionnaire: Are you currently a smoker? Yes, I currently smoke (move to For Smokers Only section) No, I quit within the last 6 months (ACTION STAGE) No, I quit more than 6 months ago (MAINTENANCE STAGE) No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours? (For smokers only) Are you seriously thinking of quitting smoking? Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE) Yes, within the next 6 months (CONTEMPLATION STAGE) No, not thinking of quitting (PRECONTEMPLATION STAGE) | During 90-session intervention period | 
| Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. |  | During 90-session intervention period | 
| Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate). |  | During the 6-month follow-up period | 
| Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days. |  | During the 6-month follow-up period | 
| Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject. | Are you currently a smoker? Yes, I currently smoke (move to For Smokers Only section) No, I quit within the last 6 months (ACTION STAGE) No, I quit more than 6 months ago (MAINTENANCE STAGE) No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours? (For smokers only) Are you seriously thinking of quitting smoking? Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE) Yes, within the next 6 months (CONTEMPLATION STAGE) No, not thinking of quitting (PRECONTEMPLATION STAGE) | During the 6-month follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Traumatic Stress Disorder Checklist | range 17-85; >50 indicates PTSD diagnosis | At end of 90-session intervention period | 
| Post Traumatic Stress Disorder Checklist | range 17-85; >50 indicates PTSD diagnosis | At the end of the 6-month follow-up period | 
| Geriatric Depression Scale | range 1-15; >6 indicates depression | At the end of the 90-session intervention period | 
| Geriatric Depression Scale | range 1-15; >6 indicates depression | At the end of the 6-month follow-up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing Care, Veterans