Clinical trial NCT01737281: Proactive Outreach for Smokers in VA Mental Health
Official title: Proactive Outreach for Smokers in VA Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Tobacco control
Counseling
mental health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-11-29
Enrollment: 1938
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Number of Participants With Cotinine-Validated Abstinence From Smoking
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
name: Scott E Sherman, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Steven S. Fu, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.1186/1471-2458-14-1294.
citation: 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.
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 Mar 15.
citation: Japuntich SJ, Hammett PJ, Rogers ES, Fu S, Burgess DJ, El Shahawy O, Melzer AC, Noorbaloochi S, Krebs P, Sherman SE. Effectiveness of Proactive Tobacco Cessation Treatment Outreach Among Smokers With Serious Mental Illness. Nicotine Tob Res. 2020 Aug 24;22(9):1433-1438. doi: 10.1093/ntr/ntaa013.