Telephone and Web-based Teen Tobacco Cessation in HMOs

Tobacco Use Clinical Trial

— QWIThelper  

Official title:

Telephone and Web-based Teen Tobacco Cessation in HMOs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311948
• Other study ID #: 5RO1 CA098685-02
• Secondary ID: 1R01CA098685-01A
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2006
• Last updated: September 27, 2012
• Start date: March 2006
• Est. completion date: April 2010

Study information

• Verified date: September 2006
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to look at both the clinicians' ability to reach out to the teen smokers and to evaluate the efficacy of providing tobacco cessation support using a proactive telephone quitline combined with an interactive Web-based program for teens within a managed care environment.

Description:

Health maintenance organizations have the mission, incentive, communication tools, and credibility with patients to reach out to teen members who use tobacco. The overall aim of this project is to refine and test both the potential reach and the efficacy of tobacco cessation support using a proactive telephone quitline combined with an interactive Web-based program for teens within a managed care environment. As part of a clinician-directed outreach effort, we will work closely with pediatric clinicians to maximize the program's reach into the teen smoker population as identified through the electronic data base of a large HMO. We will use letters and proactive outreach calls to assess current smoking status and recruit 600 15- to 18-year-old teen smokers who are interested in quitting and would be willing to receive cessation support via telephone and the Web. A second aim will be to randomly assign interested teen smokers to receive a proactive telephone- and Web-based tobacco cessation program or access to a website with cessation materials (control condition) to test the efficacy of the program on long-term cessation rates at 6- and 12-months. We will use several process measures to assess our ability to implement and consistently deliver both the telephone and Web components of the intervention. We will measure mediating variables to determine they support the hypothesized linkages between the theoretical constructs described by our cognitive behavioral model of action. An effective managed care partnership with clinicians to assess, recruit, and intervene with teen smokers would be of great interest to clinicians and health plan managers, highly exportable, and would be given high priority for implementation at the population level.

Our specific aims are as follows:

1. Compare the population-based recruitment yields and costs of three proactive outreach approaches: 1) outreach calls only to those teen smokers who are seen, advised, and referred to us by their clinician; 2) outreach calls to a random sample of teens shown as being smokers in the EMR; and 3) outreach calls to a sample of all teens

2. Assess efficacy/effectiveness in a randomized trial with 600 teen smokers to evaluate the hypothesis that proactive telephone-based counseling integrated with an interactive website will increase 6- and 12-month abstinence rates (30-day point prevalence) relative to a control condition receiving mailed cessation materials alone

3. Assess the hypothesis that the telephone and web-based intervention will improve longer-term maintenance of abstinence at an 12-month follow-up point compared to the control condition

4. Describe use patterns for key intervention process measures (e.g., calls completed, use of website) and determine if intervention affects outcome through theoretical mediators (e.g., pros/cons, stage, efficacy)

5. Determine the total costs of the telephone and web-based program from the perspective of the HMO and replication costs in other settings, and report costs as incremental costs per member per month, per program participant, and per quit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 18 Years

Eligibility

Inclusion Criteria:

• 15-18 years old

• both males and females

• smoking cigarettes at least four days a month

• some interest in quitting (will take all teen regardless of stage of readiness

• no evidence of treatment for depression, alcohol, or drugs in last year

• must consent

• have physician's approval for outreach to their panel

• have (or able to get) Internet access and phone access

• willingness to participate in study and follow-up procedures.

Exclusion Criteria:

• <15 years old

• >18 years old

• treated within 1 year for depression, alcohol, or drugs

• No internet access or phone access

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Behavioral:
• Telephone counseling + interactive website = more abstinence

• Behavioral: interactive website

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	Free & Clear, Inc.	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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* Note: There are 99 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up.	self report of smoking in last 30 days	6 months and 12 months	No
Primary	12-month measure to determine long-term assessment	Self report smoking or not smoking.	12-months	No
Secondary	A six-month assessment to determine short-term effects		6 months	No
Secondary	Assess the prevalence of smoking on 25 or more days per month		1 month	No
Secondary	Assess sustained abstinence (e.g., three and six months) at each follow-up,	No smoking - yes or no at 3 month timeframe and 6 months timeframe	3 months and 6 months	Yes
Secondary	Assess change in stage of change		6 months and 12 months	No
Secondary	Assess amount smoked, and use of other tobacco products (including smokeless tobacco) in the last week, 30 days, three months, and six months prior to the follow-up assessment.		30 days, 6 months, 12 months	No
Secondary	Measure the proportion of teen smokers who are recruited through direct physician referral versus proactive outreach		1 day	No
Secondary	Compare the population-based recruitment yields and costs of three proactive outreach approaches that health plans might implement		12 months	No