Telephone Care Coordination for Smokers in VA Mental Health Clinics

NCT00724308 | Completed Results DMC

• 1 other identifier: SDP 07-034
• Study Type: interventional
• Target: 577
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Smoking; Smoking Cessation; Tobacco; Mental Health

Outcome Measures

Primary Outcomes (1)

• Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)

  6 months after enrollment

Secondary Outcomes (4)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

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

Interventions

Telephone Care Coordination OTHER

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 1

Telephone Care Coordination with state Quitline OTHER

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.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No access to a telephone
• no mailing address
• not receiving care from a VISN 1 or VISN 3 Mental Health provider

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Related Publications (5)

• 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.

  PMID: 23497630 RESULT

• 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.

  PMID: 24903609 RESULT

• Swong S, Nicholson A, Smelson D, Rogers ES, El-Shahawy O, Sherman SE. The effectiveness of a telephone smoking cessation program in mental health clinic patients by level of mental well-being and functioning: a secondary data analysis of a randomized clinical trial. BMC Public Health. 2023 Nov 7;23(1):2190. doi: 10.1186/s12889-023-16975-z.

  PMID: 37936218 DERIVED

• Swong S, Nicholson A, Smelson D, Rogers ES, El-Shahawy O, Sherman SE. The Effectiveness of a Telephone Smoking Cessation Program in Mental Health Clinic Patients by Level of Mental Well-Being and Functioning: A Secondary Data Analysis of a Randomized Clinical Trial. Res Sq [Preprint]. 2023 Aug 24:rs.3.rs-3179446. doi: 10.21203/rs.3.rs-3179446/v1.

  PMID: 37674733 DERIVED

• 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.

  PMID: 26711163 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Personal Satisfaction

Results Point of Contact

• Title: Dr. Scott Sherman
• Organization: VA NY Harbor Healthcare System

scott.sherman@va.gov

212-686-7500

Study Officials

• Scott E Sherman, MD MPH

  Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 29, 2008
• Study Start: November 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: September 1, 2013
• Last Updated: November 17, 2020
• Results First Posted: August 5, 2014

Record last verified: 2020-10

Locations

US (1)