Proactive Outreach for Smokers in VA Mental Health

Smoking Clinical Trial

— PROMH  

Official title:

Proactive Outreach for Smokers in VA Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737281
• Other study ID #: IIR 11-291
• Secondary ID: 1I01HX000817-01A
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1938
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Proactive outreach
Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling.
• Usual care
Usual smoking cessation care from VA clinical staff.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
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	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hammett P, Fu SS, Lando HA, Owen G, Okuyemi KS. The association of military discharge variables with smoking status among homeless Veterans. Prev Med. 2015 Dec;81:275-80. doi: 10.1016/j.ypmed.2015.09.007. Epub 2015 Sep 21. — View Citation

Rogers ES, Fu SS, Krebs P, Noorbaloochi S, Nugent SM, Gravely A, Sherman SE. Proactive Tobacco Treatment for Smokers Using Veterans Administration Mental Health Clinics. Am J Prev Med. 2018 May;54(5):620-629. doi: 10.1016/j.amepre.2018.02.011. Epub 2018 M — View Citation

Rogers ES, Fu SS, Krebs P, Noorbaloochi S, Nugent SM, Rao R, Schlede C, Sherman SE. Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial. BMC Public Health. 2014 Dec 17;14:1294. doi: 10.1186/1471 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Cotinine-Validated Abstinence From Smoking	The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.	12 months
Secondary	Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes	At 12 month follow-up, participants were asked if the had smoked any cigarettes in the last 7 days	12 months