Clinical trial NCT00724308: Telephone Care Coordination for Smokers in VA Mental Health Clinics
Official title: Telephone Care Coordination for Smokers in Mental Health Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Smoking Cessation
Tobacco
Mental Health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-07-29
Enrollment: 577
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate whether a smoking cessation telephone care coordination program is effective and feasible in VA Mental Health Clinics.

Detailed description: Smoking is the leading preventable cause of death in the United States and is a particular problem among VA users and among persons with a diagnosed mental illness. The prevalence of smoking among VA mental health patients has remained high, in part because smoking cessation treatment rates have remained low. Telephone-based counseling represents the most feasible approach to increasing smoking cessation treatment among VA patients. The approach used in this study has been used very effectively in a primary care-based population that includes a large percentage of mental health patients. This project would target the program specifically at patients seen in VA Mental Health Clinics.

Eligibility criteria: Inclusion Criteria:

* Smokers who are referred from Mental Health Clinics in VA VISNs 1 and 3.
* Patients must have access to a telephone and a regular mailing address.

Exclusion Criteria:

* No access to a telephone
* no mailing address
* not receiving care from a VISN 1 or VISN 3 Mental Health provider

Primary outcomes:
measure: Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: 30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)
timeFrame: 2 months after enrollment
measure: Quit Attempt Rate
timeFrame: 2 and 6 months after enrollment
measure: Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)
timeFrame: 2 and 6 months after enrollment
measure: VA Site-level Performance Rates on the VA Tobacco Performance Measures
timeFrame: Quarterly after study implementation
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
name: Scott E Sherman, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers E, Fernandez S, Gillespie C, Smelson D, Hagedorn HJ, Elbel B, Kalman D, Axtmayer A, Kurowski K, Sherman SE. Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial. Addict Sci Clin Pract. 2013 Mar 15;8(1):7. doi: 10.1186/1940-0640-8-7.
citation: Rogers ES, Gillespie C, Zabar S, Sherman SE. Using standardized patients to train telephone counselors for a clinical trial. BMC Res Notes. 2014 Jun 5;7:341. doi: 10.1186/1756-0500-7-341.
citation: Rogers ES, Smelson DA, Gillespie CC, Elbel B, Poole S, Hagedorn HJ, Kalman D, Krebs P, Fang Y, Wang B, Sherman SE. Telephone Smoking-Cessation Counseling for Smokers in Mental Health Clinics: A Patient-Randomized Controlled Trial. Am J Prev Med. 2016 Apr;50(4):518-527. doi: 10.1016/j.amepre.2015.10.004. Epub 2015 Dec 17.