Centralized Telephone Outreach to Assist Smoking Cessation Among Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012948
First received: March 14, 2001
Last updated: February 6, 2014
Last verified: February 2007
  Purpose

Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification of tobacco use and provision of brief and/or intensive smoking cessation services are suboptimal. Telephone outreach (TO) may serve to increase access to counseling and medications to assist smoking cessation. From the standpoint of health systems, TO provides the opportunity for centralized oversight and quality assurance, economy of scale, and dissemination strategies that are practical to implement. At the provider level, TO addresses barriers to delivery of services such as limited time and skills. From the standpoint of the smoker, attractions of TO include accessibility, convenience, and privacy.


Condition Intervention Phase
Smoking
Smoking Cessation
Procedure: Telephone Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Centralized Telephone Outreach to Assist Smoking Cessation Among Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 800
Study Completion Date: September 2004
Arms Assigned Interventions
Arm 1 Procedure: Telephone Care

Detailed Description:

Background:

Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective. Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care, rates of identification of tobacco use and provision of brief and/or intensive smoking cessation services are suboptimal. Telephone outreach (TO) may serve to increase access to counseling and medications to assist smoking cessation. From the standpoint of health systems, TO provides the opportunity for centralized oversight and quality assurance, economy of scale, and dissemination strategies that are practical to implement. At the provider level, TO addresses barriers to delivery of services such as limited time and skills. From the standpoint of the smoker, attractions of TO include accessibility, convenience, and privacy.

Objectives:

The objectives of the study are to: 1) determine if TO increases successful quitting among veterans who smoke, compared to the distribution of written self-help materials; and 2) determine the cost-effectiveness of TO for smoking cessation for veterans who smoke.

Methods:

The study involved a population-based sample of veterans in VISN 13 who use one of the five Network VAMCs for primary care. 838 smokers were recruited, enrolled and randomly assigned to 1) written self-help materials + TO, or 2) written self-help materials alone. The behavioral intervention protocol included follow-up calls scheduled in a relapse-sensitive fashion. Use of nicotine replacement therapy (NRT) was encouraged, and prescriptions facilitated. Data was collected at baseline, 3 months, and 12 months by telephone. Information on demographic characteristics, medical and mental health histories, smoking history, intervention, and use of clinical services for smoking cessation was included. Cost data will be calculated from administrative databases, and will include 1) written materials, 2) counseling (personnel time, equipment, space), and 3) medications. The primary outcome was 6 months of prolonged abstinence from smoking, measured 12 months following intervention. Secondary analyses evaluated 3 month and 12 month point prevalent abstinence from smoking, quit attempts, and a formal cost-effectiveness analysis that will include total costs, total and marginal effects and cost-effectiveness ratios (average cost/quit and average cost/marginal quit) for TO and SH interventions.

Status:

Data collection and main outcome analyses have been completed. The main manuscript will be submitted to JAMA in October 2004. We are starting cost-effectiveness analyses.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must be smokers who have a phone and who speak English. They are excluded for psychiatric instability.

Exclusion Criteria:

  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: NCT00012948

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
Investigators
Principal Investigator: Anne M. Joseph, MD MPH University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012948     History of Changes
Other Study ID Numbers: SUI 99-101
Study First Received: March 14, 2001
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 19, 2014