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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00724308
Other study ID # SDP 07-034
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date September 2013

Study information

Verified date October 2020
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 577
Est. completion date September 2013
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
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.
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 "Quitline"; and (4) follow-up at 2 and 6 months to check the patient's smoking status.

Locations

Country Name City State
United States Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY New York New York

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) 6 months after enrollment
Secondary 30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment) 2 months after enrollment
Secondary Quit Attempt Rate 2 and 6 months after enrollment
Secondary Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate) 2 and 6 months after enrollment
Secondary VA Site-level Performance Rates on the VA Tobacco Performance Measures Quarterly after study implementation
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