Randomized Clinical Trial to Reduce Harm From Tobacco
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      Using the NIH-funded Way to Health platform, the investigators will conduct this smoking
      cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to
      determine the effectiveness of 4 different interventions aimed at smoking cessation, two of
      which are incentive structures that are each grounded in behavioral economic principles. The
      other interventions will determine the effectiveness of various cessation aids, including
      electronic cigarettes and text messaging, on smoking cessation. This study will be conducted
      as an opt-out procedure where participants are automatically enrolled in the program but have
      the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate
      the effects of such programs in an employee based population that can be easily mimicked in
      other employee based populations.
    

Detailed description: 
      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).
    

Intervention name(s): E-cigarette free access; E-cigarette/NRT/Zyban/Chantix Choice; Outcome Incentive arm; Loss framing incentive arm; Control
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants in this arn will be given free access to e-cigarettes to help quit smoking; Participants in this arn will be given free access to cessation aids to help quit smoking; Participants in this arm will be earn incentives across 6 months for verified abstinence.; Participants in this arm will be told they have a pre-funded account with money that is theirs if they quit smoking.; Participants will have access to information and advice on quitting smoking. This is a control and no actual intervention will be applied.
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation; behavioral economics; e-cigarettes; NRT