Piper 2016.
Study characteristics | ||
Methods | Design: Fractional factorial screening experiment Setting: Primary care clinics in southern Wisconsin, USA Recruitment: participants were recruited from 11 primary care clinics. During clinic visits, clinical care staff were prompted by electronic health record technology to invite people identified as smoking to participate in the study |
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Participants | 637 participants, 55% F, av. age 45.8, average cpd not reported | |
Interventions |
Intervention 1. Pre‐quit nicotine patch Half the participants were assigned to the active condition and received 14 mg patches for the 3 weeks prior to the TQD, while the other half did not receive prequit patches Intervention 2. Prequit nicotine gum Participants in the active condition received 2 mg nicotine gum for the 3 weeks prior to the TQD (≥ 9 pieces of gum/day, 1 piece/1 – 2 hours); the other half did not. Participants who received both Prequit Patch and Gum were told to use at least 5 pieces/day of gum, unless such use produced adverse effects Intervention 3. Preparation counseling Participants in the active condition received 3 x 20‐min counseling sessions prior to the TQD, focused on coping skills, reduction, and making practice quit attempts,while the other half of participants did not. The sessions 3 weeks and 1 week before the TQD were in‐person, and the week‐2 session was over the phone Intervention 4. In‐person counseling Participants in the intensive condition received 3 x 20‐min face‐to‐face counseling sessions: 1 week pre‐TQD, on the TQD, and at week 1. Sessions focused on skill building and intra‐treatment social support. Participants assigned to the minimal level received 1 x 3‐min in‐person session at Week‐1 Intervention 5. Phone counseling Participants in the intensive condition received 3 x 15‐min phone sessions (TQD, Days 2 and 10), focused on coping skills, avoiding smoking cues, and intra‐treatment social support. Participants assigned to the minimal condition received 1 x 10‐min session on the TQD. Thus, all participants received someTQD phone counseling Intervention 6. Extended medication All participants received combination NRT (nicotine patch + nicotine gum) starting on their TQD. Half were assigned to receive 8 weeks of patches and 8 weeks of nicotine gum. The other half received 16 weeks of patches and 16 weeks of gum |
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Outcomes | 7‐day PPA at 6m Validation: None Quit attempts |
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Funding Source | Grants from the National Cancer Institute to the University of Wisconsin Center for Tobacco Research and Intervention and by the Wisconsin Partnership Program. Dr. Collins is also supported by NIH grants | |
Author's declarations of interest | Authors declared that they had no conflict of interest | |
Notes | Strategy: Adjunctive counseling (preparation phase and cessation phase, in person and via telephone), cost‐free medications (pre‐ and post‐quit, gum and patch) Level: Patient Comparison types: Active vs. active Due to the complexity of the intervention components and combinations of intervention components tested, it was impossible to include this study in any of our meta‐analyses. Instead we describe the authors' conclusions narratively, in supplementary table 3. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Low risk | Database that used stratified permuted block randomization |
Allocation concealment | Unclear risk | No details reported |
Blinding of outcome assessors All outcomes | High risk | Smoking status self‐report. Different contact between trial arms |
Incomplete outcome data All outcomes | Low risk | The overall loss to follow‐up was 41.3% (n = 263/637); the number lost to follow‐up ranged from 36% to 46% across the 6 factors at 6 months |