'Questions About Quitting' Smoking Cessation Trial (Q2)

Kaiser Permanente

Status: Completed

Conditions: Smoking

Treatments: Behavioral: Proactive Outreach; Behavioral: Navigation; Behavioral: Testimonials; Behavioral: Message Tone

Study type: Interventional

Funder types: Other

Identifiers

NCT00992264

R01CA138598

Details and patient eligibility

About

The current study tested the effectiveness of four potentially important tailoring factors (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the context of an online motivational intervention for smoking cessation. A fifth factor was originally planned by dropped during intervention development due to confounds with the other planned factors. Information learned from this study will inform how to best design an online interventions for smoking cessation. Participants were recruited from a large, regional U.S. health plan. Using a full factorial design to screen for important main effects and 2-way interactions, participants were randomized to receive one of 16 different experimental factor combinations and followed for one year to assess program impact on smokers' use of empirically-validated cessation treatment and abstinence.

Full description

The current study is a factorial screening experiment, consistent with the Multiphase Optimization Strategy. Participants were randomly assigned to one of 16 different combinations of the 4 experimental factors. Each factor was explored on 2 contrasting levels. Each contrasting factor level was then compared to the other, resulting in 4 analytic arms. Within each arm, all participants (n = 1865) were analyzed to determine the relative effect of each contrasting factor level on the primary and secondary outcomes of interest.

Enrollment: 1,865 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Member of Group Health Cooperative
• Currently Smoking at Least 5 Cigarettes/Day
• Access to Email and the Internet
• Read and Write English
• 18 years or older
• Not currently receiving tobacco cessation treatment
• Capable of participating in online and phone surveys

Exclusion criteria

• Persons will be excluded if they do not meet above criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,865 participants in 4 patient groups

Message Tone

Experimental group

Description:

Prescriptive or Motivational Persons are randomized to receive intervention content written in either a prescriptive or motivational tone.

Treatment:

Behavioral: Message Tone

Testimonials

Experimental group

Description:

Persons are randomized to receive a personally tailored testimonial or not.

Treatment:

Behavioral: Testimonials

Navigation

Experimental group

Description:

Dictated or Non-Dictated Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking.

Treatment:

Behavioral: Navigation

Proactive Outreach

Experimental group

Description:

Email or No-Email communication Persons are randomized to receive periodic email reminders to return to the intervention website or not.

Treatment:

Behavioral: Proactive Outreach