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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00366977
Other study ID # 1 RO1-CA86242-1
Secondary ID
Status Completed
Phase Phase 3
First received August 18, 2006
Last updated April 28, 2011
Start date June 2000
Est. completion date January 2005

Study information

Verified date April 2011
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4614
Est. completion date January 2005
Est. primary completion date January 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Behavioral:
Multi-session telephone counseling

Drug:
NRT patches


Locations

Country Name City State
United States Kaiser Permanente Center for Health Research Portland Oregon
United States Oregon Health Division/Center for Disease Prevention Epidemiology Portland Oregon
United States Free and Clear, Inc. Seattle Washington

Sponsors (4)

Lead Sponsor Collaborator
Kaiser Permanente Department of Human Services, Oregon, Group Health Cooperative, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (56)

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* Note: There are 56 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat.
Secondary Participant self-reported (at 6 and 12 months) any tobacco use by type
Secondary amount used per day
Secondary stage of change
Secondary number of quit attempts
Secondary use of health plan and community cessation resources
Secondary intervention total cost, cost per participant, and cost per quit
Secondary incremental cost effectiveness ratios for each intervention compared to baseline
Secondary patterns of pharmacotherapy use
Secondary out-of-pocket expenses for cessation activities.
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