Proactive Outreach for Smokers in VA Mental Health (PROMH)
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|ClinicalTrials.gov Identifier: NCT01737281|
Recruitment Status : Completed
First Posted : November 29, 2012
Results First Posted : March 14, 2019
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: Proactive outreach Behavioral: Usual care||Not Applicable|
Tobacco use is the leading preventable cause of death in the United States and contributes up to 24% of all VA healthcare costs. Veterans enrolled in the VA healthcare system smoke substantially more than the general population, which is particularly true among Veterans diagnosed with mental illness. Patients with bipolar disorder or schizophrenia have the highest smoking rates (69% and 58-90%, respectively) followed by those with PTSD (45-63%) and depression (31-51%). Numerous barriers exist for tobacco cessation among mental health patients, including high nicotine dependency, low rates of follow through for referrals, and limited availability of tobacco treatment tailored to their needs.
Most medical care providers assess tobacco use and advise smokers to quit, but they have insufficient time to follow up with treatment, leading to low long-term quit rates. Mental health providers who often meet regularly with patients report that they find tobacco cessation outside the scope of their practice and neither assess tobacco use nor refer smokers for treatment. These practice patterns have been very difficult to change even with intensive methods and across various settings and provider types. Therefore, the investigators here propose to use the electronic medical record system to identify smokers receiving mental health care and proactively reach out to engage them in treatment in line with the following aims:
- Compare the reach and efficacy of a proactive outreach telephone-based tobacco cessation (PRO) program for patients seen in mental health to usual care (UC) advice and referral to local VA and community tobacco cessation resources.
- Model longitudinal associations between baseline sociodemographic, medical and mental health characteristics and abstinence at 6 and 12 months in the PRO and UC conditions.
Investigators will use the electronic medical record to identify N=6,400 patients across 4 VA healthcare facilities who have a clinical reminder code indicating current tobacco use in the past year and who have had a mental health visit in the past 6 months. Investigators will send each patient an introductory letter and baseline survey. Respondents will be randomized in a 1:1 fashion to intervention or control. Control participants will receive VA usual care. Intervention participants will receive proactive telephone counseling and cessation medications. Investigators will assess tobacco use at 6 and 12 months from enrollment. The primary outcome is cotinine-validated abstinence at the 12-month follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1938 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proactive Outreach for Smokers in VA Mental Health|
|Actual Study Start Date :||July 1, 2014|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2018|
Experimental: Proactive outreach
Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy.
Behavioral: Proactive outreach
Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling.
Active Comparator: Usual care
Usual smoking cessation care from clinical staff
Behavioral: Usual care
Usual smoking cessation care from VA clinical staff.
- Number of Participants With Cotinine-Validated Abstinence From Smoking [ Time Frame: 12 months ]The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.
- Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes [ Time Frame: 12 months ]At 12 month follow-up, participants were asked if the had smoked any cigarettes in the last 7 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737281
|United States, Florida|
|James A. Haley Veterans' Hospital, Tampa, FL|
|Tampa, Florida, United States, 33612|
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN|
|Minneapolis, Minnesota, United States, 55417|
|United States, New York|
|Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY|
|New York, New York, United States, 10010|
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Scott E Sherman, MD MPH||Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY|
|Principal Investigator:||Steven S. Fu, MD MSCE||Minneapolis VA Health Care System, Minneapolis, MN|