Proactive Outreach for Smokers in VA Mental Health (PROMH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01737281
Recruitment Status : Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : December 4, 2017
Information provided by (Responsible Party):
VA Office of Research and Development

November 27, 2012
November 29, 2012
December 4, 2017
July 1, 2014
June 30, 2017   (Final data collection date for primary outcome measure)
Abstinence from smoking [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01737281 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Proactive Outreach for Smokers in VA Mental Health
Proactive Outreach for Smokers in VA Mental Health
Veterans with a mental health diagnosis have higher a prevalence of smoking and higher rates of smoking-related morbidities compared to the general Veteran population. Smoking cessation treatment delivery in the VA typically depends on a visit from a health care provider. In this study, investigators will use information within the electronic medical record to identify all smokers with a mental health diagnosis at a VA health care facility and proactively reach out to enroll them in an intensive tobacco cessation treatment program. This approach could be generalized to other behaviors and provides a novel method to improve the health of an entire population of patients.


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:

Specific Aims:

  1. 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.
  2. 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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Behavioral: Proactive outreach
    Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling.
  • Behavioral: Usual care
    Usual smoking cessation care from VA clinical staff.
  • Experimental: Proactive outreach
    Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy.
    Intervention: Behavioral: Proactive outreach
  • Active Comparator: Usual care
    Usual smoking cessation care from clinical staff
    Intervention: Behavioral: Usual care

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
June 30, 2018
June 30, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current smoker (i.e., any tobacco use in past 30 days)
  • Seen in VA Mental Health Clinic in prior 12 months

Exclusion Criteria:

  • Dementia
  • Does not speak English
  • Does not have a telephone and mailing address (necessary to mail out consent materials and to deliver the telephone-based intervention)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
IIR 11-291
1I01HX000817-01A2 ( U.S. NIH Grant/Contract )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
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
VA Office of Research and Development
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP