Halpern 2018.
Study characteristics | ||
Methods | Design: Randomized clinical trial Recruitment: Eligible participants were employees and their spouses at 54 companies that used Vitality wellness programs Setting: Online resources via workplace setting (54 companies), USA Study start date: First phase of recruitment October 2014, second phase November 2015 (to meet recruitment target); Study end date: 20 April 2017 |
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Participants | Total N: 6006 N per arm: Usual care: 813; Free e‐cigarettes: 1199; Free cessation aids: 1588; Reward incentives plus free cessation aids: 1198; Redeemable deposit plus free cessation aids: 1208. Inclusion criteria:
Exclusion criteria:
51.1% women; median age 44; median cpd 10 Ecig use at baseline: 10.7% current use; 23.1% past but not current use; 39.7% never used ECs Motivated to quit: Unselected sample (total sample): 9.2% no plan to quit; 61.6% want to quit later; 27.7% want to quit/need help |
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Interventions |
EC: Cig‐a‐like a) Usual care: Standardized Vitality program aimed at promoting tobacco cessation. This program includes existing employee benefits for quitting and the use of text/email messages to encourage tobacco cessation b) as (a), plus free EC: Free NJOY e‐cigarettes (including battery sticks, a USB charger, and up to 20 chambers with 1.0 to 1.5% nicotine per week in participants’ chosen flavors). Use of all products was free until 6 months after the quit date c) as (b) plus access to free NRT, bupropion or varenicline d) as (c) plus incentives across 6 m for testing negative for tobacco use e) as (c) plus provide money at start and lose money from this fund if they do not test negative across 6 m |
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Outcomes | Months 1, 3, 6 and 12 Cessation: Sustained smoking abstinence for 6 months, biochemical validation (urine cotinine, anabasine and blood carboxyhemoglobin) Other outcomes measured: Costs |
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Study funding | "Supported by a grant from the Vitality Institute to the University of Pennsylvania Center for Health Incentives and Behavioral Economics." | |
Author declarations | "Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. Check these and: Dr. Troxel reports other from VAL Health, outside the submitted work. Dr. Volpp reports grants and personal fees from CVS Health, personal fees from VAL Health, grants from Humana, grants from Merck, grants from Weight Watchers, grants from Hawaii Medical Services Association, grants from Oscar Health Insurance, outside the submitted work. All of the other authors state that they have nothing to disclose." | |
Notes | New for 2020 update. Study listed as ongoing study NCT02328794 in 2016 review update Only arms (a) and (b) included in our analyses. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not specified |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded and different amounts of support given to each group |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation |
Incomplete outcome data (attrition bias) All outcomes | High risk | At 12 months very low numbers completed biochemical validation. Submitted a sample n = CG:1, free e‐cigs;4, free cessation:5, rewards: 14, deposits:16 |
Selective reporting (reporting bias) | Low risk | Expected outcomes reported and checked with trial registration |