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Telephone Care Coordination for Smokers in VA Mental Health Clinics (TeleQuit MH)

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ClinicalTrials.gov Identifier: NCT00724308
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : August 5, 2014
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Other: Telephone Care Coordination Other: Telephone Care Coordination with state Quitline Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Telephone Care Coordination for Smokers in Mental Health Clinics
Study Start Date : November 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
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.
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.

Experimental: Arm 2
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.
Other: 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.




Primary Outcome Measures :
  1. Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) [ Time Frame: 6 months after enrollment ]

Secondary Outcome Measures :
  1. 30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment) [ Time Frame: 2 months after enrollment ]
  2. Quit Attempt Rate [ Time Frame: 2 and 6 months after enrollment ]
  3. Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate) [ Time Frame: 2 and 6 months after enrollment ]
  4. VA Site-level Performance Rates on the VA Tobacco Performance Measures [ Time Frame: Quarterly after study implementation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724308


Locations
United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Scott E Sherman, MD MPH Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY