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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00724308
First received: July 23, 2008
Last updated: April 6, 2015
Last verified: April 2014
  Purpose
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 Intervention
Smoking
Other: Telephone Care Coordination
Other: Telephone Care Coordination with state Quitline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Telephone Care Coordination for Smokers in Mental Health Clinics

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment) [ Time Frame: 2 months after enrollment ] [ Designated as safety issue: No ]
  • Quit Attempt Rate [ Time Frame: 2 and 6 months after enrollment ] [ Designated as safety issue: No ]
  • Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate) [ Time Frame: 2 and 6 months after enrollment ] [ Designated as safety issue: No ]
  • VA Site-level Performance Rates on the VA Tobacco Performance Measures [ Time Frame: Quarterly after study implementation ] [ Designated as safety issue: No ]

Enrollment: 1206
Study Start Date: November 2009
Study Completion Date: September 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00724308     History of Changes
Other Study ID Numbers: SDP 07-034 
Study First Received: July 23, 2008
Results First Received: July 10, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Smoking
Smoking Cessation
Tobacco
Mental Health

Additional relevant MeSH terms:
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 25, 2016