NCT02328794

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,006

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

December 15, 2014

Last Update Submit

May 1, 2017

Conditions

Smoking Cessation

Keywords

smoking cessationbehavioral economicse-cigarettesNRT

Outcome Measures

Primary Outcomes (1)

  • verified abstinence 6 months

    Biometric testing (metabolites of nicotine) at 6 months following the quit date

    6 months

Secondary Outcomes (3)

  • verified abstinence 1 months

    12 months

  • verified abstinence 3 months

    12 months

  • verified abstinence 12 months

    12 months

Study Arms (5)

Control

ACTIVE COMPARATOR

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).

Behavioral: Control

E-cigarette free access

EXPERIMENTAL

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).

Behavioral: E-cigarette free access

E-cigarette/NRT/Zyban/Chantix Choice

EXPERIMENTAL

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).

Behavioral: E-cigarette/NRT/Zyban/Chantix Choice

Outcome Incentive arm

EXPERIMENTAL

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).

Behavioral: Outcome Incentive arm

Loss framing incentive arm

EXPERIMENTAL

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 earnincentives across six months through a pre-funded deposit or precommitment account. They will be notified that money has been placed into an account for them. At each time point they will lose a portion (see below) 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).

Behavioral: Loss framing incentive arm

Interventions

E-cigarette free accessBEHAVIORAL

Participants in this arn will be given free access to e-cigarettes to help quit smoking

E-cigarette free access
E-cigarette/NRT/Zyban/Chantix ChoiceBEHAVIORAL

Participants in this arn will be given free access to cessation aids to help quit smoking

E-cigarette/NRT/Zyban/Chantix Choice
Outcome Incentive armBEHAVIORAL

Participants in this arm will be earn incentives across 6 months for verified abstinence.

Outcome Incentive arm
Loss framing incentive armBEHAVIORAL

Participants in this arm will be told they have a pre-funded account with money that is theirs if they quit smoking.

Loss framing incentive arm
ControlBEHAVIORAL

Participants will have access to information and advice on quitting smoking. This is a control and no actual intervention will be applied.

Control

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vitality beneficiary
  • years or older
  • reported and/or tested positive for being a smoker
  • all participants will be able to opt-out of this program.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Harhay MO, Troxel AB, Brophy C, Saulsgiver K, Volpp KG, Halpern SD. Financial Incentives Promote Smoking Cessation Directly, Not by Increasing Use of Cessation Aids. Ann Am Thorac Soc. 2019 Feb;16(2):280-282. doi: 10.1513/AnnalsATS.201808-574RL. No abstract available.

    PMID: 30290121DERIVED

  • Halpern SD, Harhay MO, Saulsgiver K, Brophy C, Troxel AB, Volpp KG. A Pragmatic Trial of E-Cigarettes, Incentives, and Drugs for Smoking Cessation. N Engl J Med. 2018 Jun 14;378(24):2302-2310. doi: 10.1056/NEJMsa1715757. Epub 2018 May 23.

    PMID: 29791259DERIVED

MeSH Terms

Conditions

Smoking CessationVaping

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmoking

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 31, 2014

Study Start

January 1, 2015

Primary Completion

November 5, 2016

Study Completion

April 20, 2017

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations

US(1)