Efficacy and Cost of State Quitline Policies

April 28, 2011 updated by: Kaiser Permanente
State-sponsored anti-tobacco campaigns are motivating large numbers of smokers to seek advice, assistance, and support to make their cessation efforts more successful. Like many states, Oregon has sponsored the implementation of a statewide telephone quitline to provide information, referrals, and cessation support for callers. This study will answer key policy questions about how to most effectively support smokers who call the Oregon Quitline for assistance. The specific aims are to recruit 4,500 callers to participate in a 3 x 2 randomized trial comparing the cost and cost effectiveness of three levels of behavioral intervention. We will also test two different policies on the availability of nicotine patch therapy. Subjects will be interviewed by telephone at 6 and 12 months to assess smoking status, quit attempts, and use of health plan anc community cessation services. Costs will be assessed separately from the perspectives of the patients, health plans, the State (i.e., Oregon Quitline), and society. Cost per quit and cost per year quality-adjusted years of life saved will be calculated from each of these perspectives.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anti-tobacco media campaigns in many states are motivating large numbers of smokers to seek advice, assistance, and support to make their cessation efforts more successful. Like many other states, Oregon has sponsored the implementation of a statewide telephone quitline to provide information, referrals, and cessation support for callers. Two investigators on this proposal (Hollis and McAfee) have a contract with the State of Oregon to provide the Oregon Quitline (OQL) services. The purpose of the proposed research effort is to collaborate further with State representatives to answer key policy questions about how to most effectively support smokers who call the OQL for assistance.

Our overall aim is to recruit 4,500 callers to the OQL to participate in a 3 x 2 randomized trial to compare the cost and cost effectiveness of three levels of behavioral intervention. We will also test two different policies regarding the availability of nicotine patch therapy. Subjects will be interviewed by telephone at 6 and 12 months to assess smoking status, quit attempts, and use of health plan and community cessation services. Costs will be assessed separately from the perspective of the patients, health plan, the State (i.e., OQL), and society. The specific aims are described below:

  1. Compare the efficacy of three policies for supporting OQL callers:

    • Brief counseling with referral to caller's health plan cessation services (standard service);
    • Moderate counseling, referral to health plan, and one follow-up call to reinforce use of health plan services;
    • Moderate counseling, referral, and availability a multi-session telephonic intervention.

  2. Compare the efficacy of two policies regarding the provision of nicotine replacement:

    • No offer of nicotine replacement (current policy);
    • An offer of free nicotine replacement patches.

  3. Determine the costs and cost per quit of the additional policy interventions relative to usual care (i.e., standard service) from the following perspectives:

    • Societal perspective (total incremental costs per incremental quit);
    • State perspective (incremental cost per quit for OQL services);
    • Health plan perspective (based on differences in use of health plan cessation services);
    • Participant's perspective (based on differences in out-of-pocket expenses).
  4. Determine the incremental cost per year-of-life saved for the alternative policies relative to usual care.

Study Type

Interventional

Enrollment (Actual)

4614

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research
      • Portland, Oregon, United States, 97232
        • Oregon Health Division/Center for Disease Prevention Epidemiology
    • Washington
      • Seattle, Washington, United States, 98104
        • Free and Clear, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18+
  • Speak English or Spanish
  • Oregon resident
  • Smoke 5 or more cigarettes/day
  • Planning to quit within 30 days (or quit within in last 7 days)
  • Consent to random assignment and follow-up

Exclusion Criteria:

  • Health plan benefit includes free multi-session telephone counseling
  • Current or planned pregnancy or breast-feeding
  • Heart attack within the preceding month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat.

Secondary Outcome Measures

Outcome Measure
Participant self-reported (at 6 and 12 months) any tobacco use by type
amount used per day
stage of change
number of quit attempts
use of health plan and community cessation resources
intervention total cost, cost per participant, and cost per quit
incremental cost effectiveness ratios for each intervention compared to baseline
patterns of pharmacotherapy use
out-of-pocket expenses for cessation activities.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Cancer Institute (NCI)
Department of Human Services, Oregon

Investigators

  • Principal Investigator: Jack F. Hollis, PhD, Kaiser Permanente Foundation Hospitals/Center for Health Research
  • Principal Investigator: Timothy A McAfee, MD, Group Health Center for Health Promotion
  • Principal Investigator: Michael J Stark, PhD, Oregon Health Division/Center for Disease Prevention Epidemiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

August 18, 2006

First Submitted That Met QC Criteria

August 18, 2006

First Posted (Estimate)

August 22, 2006

Study Record Updates

Last Update Posted (Estimate)

May 2, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1 RO1-CA86242-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe