Proactive Outreach for Smokers in VA Mental Health (PROMH)

March 18, 2019 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1938

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • James A. Haley Veterans' Hospital, Tampa, FL
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System, Minneapolis, MN
    • New York
      • New York, New York, United States, 10010
        • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center, Houston, TX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIR 11-291
  • 1I01HX000817-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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