Randomized Clinical Trial to Reduce Harm From Tobacco

Overall objectives Our primary objective is to determine which of four interventions improve
smoking cessation rates in beneficiaries of the Vitalilty/Discovery program. The
investigators plan to compare the effectiveness standard intervention (control) that
includes text messaging aimed at encouraging cessation to four interventions: 1) choice of
free (traditional) cessation aids (NRT: gum or patch), 2) free e-cigarettes, 3) Choice of
free cessation aids (NRT or e-cigarettes) and reward based incentives for cessation, and 4)
Choice of free cessation aids (NRT or e-cigarettes) and a virtual deposit-based incentives
for cessation.

Primary outcome variable: Urine cotinine, anabasine, or blood carboxyhemoglobin testing
(metabolites of nicotine) at 6 months following the quit date.

Secondary outcome variable: Urine cotinine, anabasine, or blood carboxyhemoglobin testing
(metabolites of nicotine) at 1 month, 3 months, and 12 months following the quit date.

Background Tobacco use remains one of the most preventable causes of disease, disability,
and death worldwide (CDC, 2014). Rates of smoking in the US have decreased to 18.1% in 2012
but remain far from the cessation goals set by tobacco prevention organizations (12% by 2020
in the US). To achieve these cessation goals and reduce harm from tobacco, the investigators
need to both implement proven strategies to promote cessation and develop new approaches to
increasing tobacco cessation (Frieden, 2014). Vitality is the wellness program for over 25
companies in the US. They are charged with providing a variety of wellness programs for the
employees of companies they represent. These programs span a variety of health behaviors
including tobacco use, obesity, healthy eating, driving while texting and many more.

Financial incentives have been effective in improving health in a variety of areas,
including smoking cessation (Heil et al., 2008; Loewenstein et al., 2012; Lynagh et al.,
2013; Sutherland et al., 2008; Volpp et al., 2009 ). In the largest (n = 878) and most
successful trial, Volpp and colleagues (2009) found that financial incentives, totaling
$750, increased long-term smoking cessation rates from 5.0% in the control group to 14.7% in
the incentive group 12 months after quitting. Following a period of 6 months where
incentives were discontinued this difference between groups remained intact, supporting the
use of incentives for sustainable cessation efforts. Strong evidence supporting the use of
incentives for smoking cessation and the allowance granted by the Affordable Care Act for
employers to use up to 30% of total premiums for outcomes-based rewards or penalties has led
to an increase in use of financial incentives by employers. An estimated 82% of large
employers in 2013 used financial incentives to promote healthy behavior (Volpp, 2014). While
financial incentives have been shown to improve rates of healthy behaviors, basic research
in behavioral economics suggests that how you pay these incentives may be critical.
Behavioral economics suggests that loss aversion may promote more behavior change than
reward-based incentives. Whether or not this holds true in large employer based populations
where participants are auto-enrolled has yet to be determined. The investigators propose
conducting a 5- arm study examining the use of different financial incentive structures and
new technologies to promote smoking cessation in Vitality members in the US. The relative
effectiveness of how incentives are paid out is unknown. To shed light on this fundamental
question the investigators will examine how incentives for assistance in quitting compare to
incentives delivered for evidence of smoking abstinence and deposit contracts. Additionally
the utility of e-cigarettes in promoting abstinence is not well understood. The use of
e-cigarettes and other smoking cessation tools will be promoted and provided across all
experimental arms so that the of the effectiveness of these aides can also be evaluated. The
primary objective will be to identify differences in long-term abstinence rates. Secondary
objectives include assessing sustained abstinence at follow-up. An opt-out enrollment
procedure will be used for this study. All participants will have previously tested positive
for cotinine and reported being a smoker, will be 18 years of age or older, will be a
beneficiary of Vitality, and will have the opportunity to terminate their participation at
any time. Employing an opt-out design for this trial will help to connect high-risk smokers,
who are largely interested in changing their behavior, to potentially helpful treatments
that they may not otherwise seek out. Below we describe the many reasons why an opt-out
enrollment is appropriate for this trial. 1) An opt-out design is essential to answer the
questions we are interested in: what rates of sustained smoking abstinence might an insurer
expect to generate if it actually rolled out the interventions to be tested among its
beneficiaries, and how do these interventions compare in terms of their effectiveness? Thus,
in designing this trial, we explicitly aimed to mimic the roll out of a health initiative in
a real-world setting; opt-out consent, whereby beneficiaries are engaged with the program
unless they actively choose otherwise, is how such programs would be rolled out in the real
world. As programs similar to the current trial are being developed and disseminated across
the country it is imperative that we examine how interventions perform under these
conditions. Enrolling large numbers of smokers in a study in which all will be offered some
form of assistance with cessation provides high expected benefits, both to enrolled
participants and in terms of the knowledge to be gained. While smoking rates have reduced to
18% in the United States, smoking related illness still remains the leading cause of
preventable death in the United States. More than 75% of current American smokers wish to
quit; 45% do quit for at least a day each year; and anti-smoking policies, new
pharmaceuticals, and behavioral modification programs offer promise to help them.
Nevertheless, only 2-3% of smokers attain prolonged abstinence annually. Given this high
interest in quitting smoking, and low rates of successfully sustaining quit attempts with
currently available programs, opt-out consent will ensure that all smokers will have the
same access to potentially helpful programs without the added barrier of completing a
lengthy enrollment/consent process. Vitality is committed to using the most effective means
of reducing major risks to health in its membership and employee base. In order to achieve
this goal they are working with innovative researchers at the University of Pennsylvania
Center for Health Incentives and Behavioral Economics (CHIBE). Within the Vitality US
population 13% of members tested positive for tobacco use. In the South African Vitality
employee population smoking prevalence is estimated at 22%. Vitality is launching a study on
tobacco cessation using incentives and new nicotine technologies for members in the US.
Findings of the study will be published and used for development of a smoking cessation
program offerings for Vitality. If successful this trial could serve as a model for other
organizations interested in implementing a similar program. This study will use the National
Institute on Aging supported Way to Health technology (RC2-AG036592) which has been used in
many previous studies of this nature. As outlined in the Appendix, this web-based behavioral
research infrastructure will substantially increase the efficiency of patient enrollment and
tracking, data management, and incentive collection and disbursement, thereby enabling much
larger studies than was possible previously.

Participants eligible for this trial will have been previously identified by the
Vitality/Discovery group during various assessments they have conducted. All who meet our
minimum eligibility requirements (18 years or older, smoke at least 5 cigarettes a day,
tested positive for cotinine at a previous health screening) will be automatically enrolled
into this study and randomized to one of four experimental arms and a control arm. All
participants will be enrolled on the same day. Furthermore, all participants will be given
the same quit date, a date one month from enrollment. This program will require participants
to indicate their smoking status and provide samples for verification of abstinence at
pre-determined dates after their quit date (1 month, 3 months, 6 months and 12 months post
quit date). Participants who report having successfully quit will be asked to undergo a
urine cotinine and anabasine test at 1 month, 3 months,6 months, and 12 months following
their quit date. Cotinine will be used to determine abstinence in participants not reporting
the use of NRT or ecigarettes. Anabasine will be used to determine abstinence for
participants reporting use of NRT or ecigarettes, as cotinine tests cannot distinguish
cigarette nicotine from replacement therapy nicotine. Participants who test positive for
both cotinine and anabasine but report using only e-cigarettes and no other tobacco products
will be asked to submit to a secondary test to determine abstinence. This test will be a
blood carboxyhemoglobin test. Control Arm: Participants randomized to this arm will receive
a 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. No incentives will be given to participants randomized to this arm. Free
cessation aids will not be available to participants in this arm. They will receive
compensation for completing study related activities (sample submissions). E-cigarette arm
(Arm 2): Participants randomized to this experimental arm will receive the standardized
program including text/email messaging and will have access to free e-cigarettes only. These
products can be ordered directly, free of charge, through the web-based interface. No
incentives will be given to participants randomized to this arm. They will receive
compensation for completing study related activities (sample submissions).
E-cigarette/NRT/Zyban/Chantix Choice arm (Arm 3): Participants randomized to this
experimental arm will receive the standardized program including text/email messaging and
will have access to free e-cigarettes, conventional Nicotine Replacement Therapy (NRT),
Zyban, or Chantix. Each of these can be ordered directly, free of charge, through the
web-based interface. No incentives will be given to participants randomized to this arm.
They will receive compensation for completing study related activities (sample submissions).
Outcome Incentive arm (Arm 4): Participants randomized to this experimental arm will receive
the standardized program and access to free e-cigarettes, NRT, Zyban, or Chantix. In
addition, they will also be able to earn incentives across six months for testing negative
for tobacco use (see Incentive payout, below). They will also receive compensation for
completing study related activities (sample submissions). Loss framing incentive arm (Arm
5): Participants randomized to this experimental arm will receive the standardized program
and access to free e-cigarettes, NRT, Zyban, or Chantix. In addition they will also be able
to earn incentives across six months through a pre-funded deposit or precommitment account.
They will be notified that an incentive has been placed into an account for them. At each
time point they will lose a portion of this initial funding if they do not provide
biochemical evidence of abstinence. They will also receive compensation for completing study
related activities (sample submissions).

Inclusion Criteria:

- Vitality beneficiary

- 18 years or older

- reported and/or tested positive for being a smoker

- all participants will be able to opt-out of this program.

Exclusion Criteria:

- Participants who express wanting to opt-out of this program will be un-enrolled and
excluded