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

Telephone Care Coordination for Smokers in Mental Health Clinics

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: Telephone Care Coordination; Other: Telephone Care Coordination with state Quitline

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
• Enrollment (Actual): 577
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)	6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 23, 2008
• First Submitted That Met QC Criteria: July 23, 2008
• First Posted (Estimate): July 29, 2008

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Mental Health; Smoking; Tobacco; Smoking Cessation
• Other Study ID Numbers: SDP 07-034