Proactive Outreach for Smokers in VA Mental Health (PROMH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01737281
First received: November 27, 2012
Last updated: August 19, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Abstinence from smoking [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 6400
Study Start Date: July 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737281

Contacts
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

Locations
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Erin Rogers, MPH    212-686-7500 ext 7358    erin.rogers@va.gov   
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Erin Rogers, MPH    212-686-7500 ext 7358    erin.rogers2@va.gov   
United States, New York
New York, NY 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         
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Not yet recruiting
Houston, Texas, United States, 77030
Contact: Erin Rogers, MPH    212-686-7500 ext 7358    erin.rogers2@va.gov   
Sponsors and Collaborators
Investigators
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: August 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Smoking
Tobacco control
Counseling
mental health

ClinicalTrials.gov processed this record on October 02, 2014