Proactive Outreach for Smokers in VA Mental Health

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: Proactive outreach; Behavioral: Usual care

• Registration Number: NCT01737281
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

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:

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Study Start: 2014-07-01
• Primary Completion: 2017-06-30
• Study Completion: 2018-06-30
• Results First Submitted: 2018-11-19
• Results First Submitted QC: 2018-11-19
• Status Verified: 2019-03
• Results First Posted: 2019-03-14
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1938

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive outreach	Proactive outreach	Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy.
Usual care	Usual care	Usual smoking cessation care from clinical staff

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cotinine-Validated Abstinence From Smoking	12 months	The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes	12 months	At 12 month follow-up, participants were asked if the had smoked any cigarettes in the last 7 days

Trial Locations

Locations (4)

James A. Haley Veterans' Hospital, Tampa, FL; 🇺🇸 Tampa, Florida, United States

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY; 🇺🇸 New York, New York, United States

Michael E. DeBakey VA Medical Center, Houston, TX; 🇺🇸 Houston, Texas, United States