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

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ClinicalTrials.gov Identifier: NCT02601521
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Partners HealthCare, Inc.
Information provided by (Responsible Party):
Nancy A. Rigotti, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Tobacco Use Disorder Behavioral: Internal tobacco coach Behavioral: External tobacco coach Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Two Tobacco Cessation Interventions for Employees of Partners HealthCare, Inc.
Study Start Date : November 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Internal coaching program
The internal coaching program uses a chronic disease management strategy to treat tobacco use and dependence. The program provides evidence-based treatment consisting of up to 12 months of services from a tobacco coach based at Partners HealthCare. The tobacco coach offers (1) repeated smoking cessation counseling delivered by proactive telephone calls, emails, and interactive voice response [automated phone calls] and (2) facilitated access to a new Partners HealthCare Inc., health insurance benefit that provides access to all FDA-approved smoking cessation medications without copay or prior approval.
Behavioral: Internal tobacco coach

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:

  1. 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.
  2. The Tobacco Coach will assist smokers in choosing pharmacotherapy and in obtaining a prescription from the smoker's physician.
  3. 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.

Active Comparator: External coaching program
The external coaching program consists of referral to the Massachusetts Tobacco Control Program's Smokers Helpline, a free program offering multi-session proactive telephone counseling for 3 months to individuals who are ready to quit smoking. Individuals in this arm also receive information about Partners HealthCare, Inc.'s new health insurance benefit that provides access to all FDA-approved smoking cessation medications without copay or prior approval.
Behavioral: External tobacco coach
Referral to Massachusetts Smokers Helpline (telephone quitline operated by the Massachusetts Tobacco Control Program) for proactive telephone counseling.




Primary Outcome Measures :
  1. Tobacco abstinence for the past 30 days [ Time Frame: 6 months after enrollment ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601521


Contacts
Contact: Jennifer H Kelley, RN 781-433-3041 jkelley4@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jennifer Kulesa-Kelley, RN    781-433-3041    jkelley4@partners.org   
Principal Investigator: Nancy Rigotti, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Partners HealthCare, Inc.
Investigators
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital

Responsible Party: Nancy A. Rigotti, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02601521     History of Changes
Other Study ID Numbers: 2015P000002/MGH
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders