Fraser 2017.
Methods | 2‐group randomised clinical trial. 2013 to 2017 Country: USA Setting: recruited from Wisconsin Quit Line, primary care clinics, and community advertisements |
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Participants | 1900 community‐dwelling smokers accessing a quit line or recruited from primary care or advertising CG: n = 952; IG: n = 948 60% women. Mean age 45. Mean CPD = 16. 51% and 41% black and white respectively. Education: 61% high school or less |
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Interventions |
Control Group: All participants were incentivised for participating in baseline and 6‐month follow‐up biochemical assessment visits. Quit line coaching included a pre‐quit call that typically occurred at study enrolment and 4 additional proactive calls. Participants could also initiate calls to the WTQL for additional assistance. WTQL quit coaches made 3 attempts (per protocol) on different days to reach a participant for each proactive call, leaving messages at least twice if possible. Those callers not reached on the first 2 proactive calls were sent a letter urging them to call. Study participants also received a mailed quit guide, access to recorded medication information (by phone), and access to Web Coach®, an online cessation programme maintained by the quit line. WTQL quit coaches routinely recommended that participants obtain a prescription for a Medicaid‐approved smoking cessation medication from their primary care provider (at minimal or no co‐pay). Participants in the control condition could receive a total incentive of USD 80: USD 40 each for attendance at the baseline and 6‐month follow‐up biochemical assessment visits. Compensation was in the form of prepaid Visa gift cards and took 2 to 4 weeks from the point of contact Experimental Group(s): All participants were incentivised for participating in baseline and 6‐month follow‐up biochemical assessment visits. Incentive condition participants were additionally incentivised for participating in WTQL calls and for biochemically determined abstinence at the 6‐month follow‐up visit. Participants in the Incentive condition could receive a total payment of USD 270: USD 30/call for up to 5 WTQL calls, USD 40/visit for attending the baseline and 6‐month follow‐up assessment visit, and USD 40 for producing biochemical evidence of abstinence at the 6‐month follow‐up visit Theoretical basis for intervention: None specified Duration of intervention: 6 months Length of follow‐up: 6 months |
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Outcomes | PPA at 6 months. CO ≥ 7 ppm. Clinics chose different cut‐scores for the urine cotinine test; Almost all the clinics chose to define smoking as a value that exceeded either 50 ng/mL, 100 ng/mL, or 200 ng/mL, depending on the clinic. 4 clinics used 300 ng/mL as the smoking cut‐score. Treatment engagement, medication use | |
Notes | New for 2019 update Funding: "This research was supported by Funding Opportunity Number 1B1CMS330876 from the Centers for Medicare & Medicaid Services." Decarations of interest: "No financial disclosures were reported by the authors of this paper." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation occurred by computer‐generated lists (Appendix, available online), with order stratified by county and race |
Allocation concealment (selection bias) | Unclear risk | Quote: “These randomization lists were supplied by the research team to the Wisconsin Tobacco QL and then programmed to automatically determine randomization at the time required in the consent protocol” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 552 intervention (58%) and 562 control followed up at 6 months (59%) |