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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Message Tone | Experimental | Prescriptive or Motivational Persons are randomized to receive intervention content written in either a prescriptive or motivational tone. |
|
| Testimonials | Experimental | Persons are randomized to receive a personally tailored testimonial or not. |
|
| Navigation | Experimental | 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. |
|
| Proactive Outreach | Experimental | Email or No-Email communication Persons are randomized to receive periodic email reminders to return to the intervention website or not. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Message Tone | Behavioral | All participants receive an tailored, online smoking cessation program. Participants in this intervention group either receive content written in a prescriptive tone or a motivational tone. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence | 7 day point prevalent abstinence | 12 months |
| Treatment Utilization for Smoking Cessation | confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer B McClure, PhD | Group Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22771577 | Background | McClure JB, Derry H, Riggs KR, Westbrook EW, St John J, Shortreed SM, Bogart A, An LC. Questions about quitting (Q2): design and methods of a Multiphase Optimization Strategy (MOST) randomized screening experiment for an online, motivational smoking cessation intervention. Contemp Clin Trials. 2012 Sep;33(5):1094-102. doi: 10.1016/j.cct.2012.06.009. Epub 2012 Jul 4. | |
| 23529377 | Result | McClure JB, Shortreed SM, Bogart A, Derry H, Riggs K, St John J, Nair V, An L. The effect of program design on engagement with an internet-based smoking intervention: randomized factorial trial. J Med Internet Res. 2013 Mar 25;15(3):e69. doi: 10.2196/jmir.2508. |
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Participants were recruited from Group Health, a large, non-profit health plan in the US Pacific Northwest. Data were collected between May 2010 and November 2012. All intervention and data collection occurred online.
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomization Arm 1 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [yes] |
| FG001 | Randomization Arm 2 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [yes] |
| FG002 | Randomization Arm 3 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [yes] |
| FG003 | Randomization Arm 4 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [yes] |
| FG004 | Randomization Arm 5 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [no] |
| FG005 | Randomization Arm 6 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [no] |
| FG006 | Randomization Arm 7 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [no] |
| FG007 | Randomization Arm 8 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [no] |
| FG008 | Randomization Arm 9 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [yes] |
| FG009 | Randomization Arm 10 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [yes] |
| FG010 | Randomization Arm 11 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [yes] |
| FG011 | Randomization Arm 12 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [yes] |
| FG012 | Randomization Arm 13 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [no] |
| FG013 | Randomization Arm 14 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [no] |
| FG014 | Randomization Arm 15 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [no] |
| FG015 | Randomization Arm 16 | Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [no] |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1865 participants were enrolled and randomized. For the analyses, participants assigned to each contrasting level of each of the 4 experimental factors were compared against one another. Thus, 1865 people were in each analytic arm in this factorial screening experiment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomization Arm: 1 | Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [yes]. |
| BG001 | Radndomization Arm: 2 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Abstinence | 7 day point prevalent abstinence | Missing data imputed, so all enrolled participants were included in the final intent to treat analytic sample. | Posted | Number | percentage of abstinent participants | 12 months |
|
Adverse events were monitored from May 2010 until November 2012, the time during which participants were actively enrolled in this trial.
Participants were instructed to contact study staff in the event of adverse events, including changes in their health or medical status. Other potential adverse events (e.g., breach of confidentiality) were monitored by study staff.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Message Tone | Prescriptive or Motivational Persons are randomized to receive intervention content written in either a prescriptive or motivational tone. |
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The study was powered to detect differences between each factor level of 5% or more.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer McClure | Group Health Research Institute | 206-287-2737 | mcclure.j@ghc.org |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073865 | Cigarette Smoking |
| D015438 | Health Behavior |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
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| Navigation | Behavioral | Persons in this arm either have their ability to navigate the site dictated for them based on their readiness to quit smoking or they are able to freely navigate through the website. |
|
| Proactive Outreach | Behavioral | Persons receive periodic, proactively delivered email reminders to visit the intervention website. |
|
| Testimonials | Behavioral | People receive a personally-tailored testimonial as part of their online smoking cessation program. |
|
| 24727369 | Result | McClure JB, Peterson D, Derry H, Riggs K, Saint-Johnson J, Nair V, An L, Shortreed SM. Exploring the "active ingredients" of an online smoking intervention: a randomized factorial trial. Nicotine Tob Res. 2014 Aug;16(8):1129-39. doi: 10.1093/ntr/ntu057. Epub 2014 Apr 11. |
| 24263289 | Derived | Shortreed SM, Bogart A, McClure JB. Using multiple imputations to accommodate time-outs in online interventions. J Med Internet Res. 2013 Nov 21;15(11):e252. doi: 10.2196/jmir.2781. |
Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
| BG002 | Randomization Arm: 3 | Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [yes]. |
| BG003 | Randomization Arm: 4 | Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [yes]. |
| BG004 | Randomization Arm: 5 | Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [no]. |
| BG005 | Randomization Arm: 6 | Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [no]. |
| BG006 | Randomization Arm: 7 | Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [no]. |
| BG007 | Randomization Arm: 8 | Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [no]. |
| BG008 | Randomization Arm: 9 | Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [yes]. |
| BG009 | Randomization Arm: 10 | Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [yes]. |
| BG010 | Randomization Arm: 11 | Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [yes]. |
| BG011 | Randomization Arm: 12 | Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [yes]. |
| BG012 | Randomization Arm: 13 | Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [no]. |
| BG013 | Randomization Arm: 14 | Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [no]. |
| BG014 | Randomization Arm: 15 | Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [no]. |
| BG015 | Randomization Arm: 16 | Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [no]. |
| BG016 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Navigation: Dictated | Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking. Persons in the comparison group could freely navigate the website. |
| OG003 | Proactive Outreach | Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website. Persons in the comparison group did not receive proactive email reminders. |
|
|
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| Primary | Treatment Utilization for Smoking Cessation | confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program | Twenty-seven participants were excluded for not being enrolled in the health plan during the study period and not having access to the provided adjunct treatment. | Posted | Number | % of participants using adjunct treatmen | 12 months |
|
|
|
|
| 0 |
| 1,865 |
| 0 |
| 1,865 |
| EG001 | Testimonials | Testimonial or No Testimonial Persons are randomized to receive a personally tailored testimonial or not. | 0 | 1,865 | 0 | 1,865 |
| EG002 | Navigation | 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. | 0 | 1,865 | 0 | 1,865 |
| EG003 | Proactive Outreach | Email or No-Email communication Persons are randomized to receive periodic email reminders to return to the intervention website or not. | 0 | 1,865 | 0 | 1,865 |
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| treatment utilization: % in comparison group |
|
Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932). |
| Odds Ratio (OR) |
| 0.70 |
| 2-Sided |
| 95 |
| 0.46 |
| 1.07 |
OR for use of adjunct treatment at 12 months when persons assigned to receive a Testimonial were compared to persons assigned to receive No Testimonial (ref group). |
| Superiority or Other |
| Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931). | Odds Ratio (OR) | 0.78 | 2-Sided | 95 | 0.51 | 1.18 | OR for use of adjunct treatment at 12 months when persons assigned to Dictated Navigation were compared to persons not assigned to Dictated Navigation (ref group). | Superiority or Other |
| Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932). | Odds Ratio (OR) | 0.67 | 2-Sided | 95 | 0.44 | 1.03 | OR for use of adjunct treatment at 12 months when persons assigned to Proactive Email reminders were compared to persons not assigned to receive Proactive Email reminders (ref group). | Superiority or Other |