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OpenTrials
Completed

NCT Number: NCT02601521

Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc.

Specific Aim: To conduct a randomized controlled trial among permanent employees of Partners HealthCare, Inc., and their adult dependents, who are current tobacco smokers. The trial will compare two interventions designed to help smokers stop using tobacco: (1) External Coaching Program (Standard Care) and (2) Internal Coaching Program, a chronic disease management strategy for treating tobacco use and dependence.

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Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current permanent employee of Partners Healthcare, Inc. or their adult dependent
  • Current tobacco smoker (smoked a cigarette, even a puff, in the past 30 days)

Exclusion criteria

  • Temporary, per diem or former employee of Partners Healthcare, Inc.
  • Plan to leave Partners employment in the next 12 months
  • Inability to give informed consent or participate in counseling due to serious psychiatric disorder or cognitive disorder

Treatment and study plan

Internal tobacco coach

Behavioral

The internal coaching program will provide cognitive-behavioral counseling and medication adherence support for smokers who are ready to quit in the next 3 months It consists of:

  • Telephone counseling by the Tobacco Coach (8 calls over 12 weeks). supplemented by automated phone calls using interactive voice response. At each IVR contact, smokers can request a call back from the Tobacco Coach. Smokers who are not quit after 3 months can restart into the 12-week counseling program.
  • The Tobacco Coach will assist smokers in choosing pharmacotherapy and in obtaining a prescription from the smoker's physician.
  • Support and monitoring for 12 months using automated phone calls. If relapse occurs, the smoker will have the option to return to the active 12-week program.

External tobacco coach

Behavioral

Referral to Massachusetts Smokers Helpline (telephone quitline operated by the Massachusetts Tobacco Control Program) for proactive telephone counseling.

Primary outcomes

  1. Tobacco abstinence for the past 30 days

    Time frame: 6 months after enrollment

Secondary outcomes

  1. Tobacco abstinence for the past 30 days

    Time frame: 3 months after enrollment

  2. Tobacco abstinence for the past 30 days

    Time frame: 12 months after enrollment

  3. Quit attempt

    Time frame: Intentional tobacco abstinence for at least 24 hours since enrollment

Other outcomes

  1. Duration of use of tobacco cessation pharmacotherapy

    Time frame: at 3 months and at 6 months after enrollment

    Includes any FDA-approved product (nicotine patch, gum, lozenge, inhaler, nasal spray or bupropion or varenicline

  2. Smoking cessation counseling contacts

    Time frame: at 3 months and at 6 months after enrollment

    Number of telephone calls with an internal or external tobacco coach to address smoking cessation

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Partners HealthCare, Inc.

Registry information

Acronym: PiHQ

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Nov 10, 2015
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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