Message Framing for Telephone Quitline Callers

Yale University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Nicotine Dependence; Smoking

Treatments: Behavioral: Standard care counseling + standard materials; Behavioral: Gain-Framed counseling & Gain-framed materials

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00589277

R21CA127818 (U.S. NIH Grant/Contract)

0705002661 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study.

Full description

This pilot study is meant to be translational (i.e., positive study results could easily translate to the actual practices of the NYS Smokers' Quitline) - as much as possible, the standard practices of the Quitline will be followed. In this context, a randomized pilot clinical trial comparing exclusively "Gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials will be conducted with individuals calling the NYS Smokers' Quitline for assistance in quitting smoking. Following assessment of eligibility and informed consent, 2,500 smokers will be assisted by Specialists in either the YC or SC experimental conditions.

Consistent with the current practices of the Quitline, following the counseling intervention, participants will be mailed a package containing print materials encouraging smoking cessation, and participants eligible for Nicotine replacement therapy (NRT) will receive a 2-week supply of nicotine replacement medication. Consistent with Quitline practices, all callers will be required to set a "quit date" within 2 weeks of their initial call. A Quitline Specialist will initiate a follow-up call approximately 10 to 14 days after the print materials and NRT has been mailed. For callers receiving NRT, the manufacturer's suggested course of therapy (e.g., 8 weeks of NRT) will be recited to callers, and Quitline Specialists will suggest that callers use the money they save from not smoking to purchase additional NRT and/or that they check with their insurance carrier to see if additional NRT would be covered.

Participants will be assessed before receiving the gain-framed counseling + gain-framed materials or standard care counseling, immediately after receiving counseling, approximately 1 week after their quit date for those who receive NRT, and at a 3-month follow-up to see if the gain-framed counseling + gain-framed materials participants, as predicted, are more likely to promote smoking cessation. Several brief measures that assess potential mediator of treatment will be administered.

Enrollment: 2,032 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (18+ years)
• New York State residents
• English-speaking
• Current smokers who utilize Quitline services seeking quitting assistance for themselves

Exclusion criteria

• Callers who are enrolled in the Proactive Program for Medicaid/uninsured clients, or special programs through their insurance company or county

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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2,032 participants in 2 patient groups, including a placebo group

Gain-Framed counseling & Gain-framed materials

Experimental group

Description:

Novel messages for quitting smoking

Treatment:

Behavioral: Gain-Framed counseling & Gain-framed materials

Standard care counseling + standard materials

Placebo Comparator group

Description:

Standard care counseling + standard care print information

Treatment:

Behavioral: Standard care counseling + standard materials