Telephone Care Coordination for Smokers in VA Mental Health Clinics

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: Telephone Care Coordination; Other: Telephone Care Coordination with state Quitline

• Registration Number: NCT00724308
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-29
• Study Start: 2009-11
• Primary Completion: 2012-10
• Study Completion: 2013-09
• Results First Submitted: 2014-07-10
• Results First Submitted QC: 2014-07-10
• Results First Posted: 2014-08-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 577

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Telephone Care Coordination	The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from TeleQuit MH study counselors; and (4) follow-up at 2 and 6 months to check the patient's smoking status.
Arm 2	Telephone Care Coordination with state Quitline	The telephone care coordination program involves the following steps: (1) brief counseling and referral from a mental health provider; (2) prescribing and mailing of smoking cessation medications; (3) proactive multi-call counseling from the patient's state smoking cessation "Quitline"; and (4) follow-up at 2 and 6 months to check the patient's smoking status.

Primary Outcome Measures

Name	Time	Method
Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)	6 months after enrollment

Secondary Outcome Measures

Name	Time	Method
30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)	2 months after enrollment
Quit Attempt Rate	2 and 6 months after enrollment
Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)	2 and 6 months after enrollment
VA Site-level Performance Rates on the VA Tobacco Performance Measures	Quarterly after study implementation

Trial Locations

Locations (1)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY; 🇺🇸 New York, New York, United States