Proactive Outreach for Smokers in VA Mental Health (PROMH)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Smoking |
Behavioral: Proactive outreach Behavioral: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Proactive Outreach for Smokers in VA Mental Health |
- Abstinence from smoking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 6400 |
| Study Start Date: | October 2013 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Detailed Description:
Background:
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.
Rationale:
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:
- 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.
Methods:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| Contact: Erin S Rogers, MPH | (212) 686-7500 ext 7358 | erin.rogers2@va.gov |
| Contact: Scott E Sherman, MD MPH | (212) 686-7500 ext 7386 | Scott.Sherman@va.gov |
| United States, New York | |
| New York, NY | Not yet recruiting |
| New York, New York, United States, 10010 | |
| Contact: Erin S Rogers, MPH 212-686-7500 ext 7358 erin.rogers2@va.gov | |
| Contact: Scott E Sherman, MD MPH (212) 686-7500 ext 7386 Scott.Sherman@va.gov | |
| Principal Investigator: Scott E. Sherman, MD MPH | |
| Principal Investigator: | Scott E. Sherman, MD MPH | New York, NY |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01737281 History of Changes |
| Other Study ID Numbers: | IIR 11-291, 1I01HX000817-01A2 |
| Study First Received: | November 27, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Smoking Tobacco control Counseling mental health |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 23, 2013