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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Use Disorder
• Intervention / Treatment: Behavioral: Internal tobacco coach; Behavioral: External tobacco coach

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tobacco abstinence for the past 30 days	6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Tobacco abstinence for the past 30 days	3 months after enrollment
Tobacco abstinence for the past 30 days	12 months after enrollment
Quit attempt	Intentional tobacco abstinence for at least 24 hours since enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of use of tobacco cessation pharmacotherapy	Includes any FDA-approved product (nicotine patch, gum, lozenge, inhaler, nasal spray or bupropion or varenicline	at 3 months and at 6 months after enrollment
Smoking cessation counseling contacts	Number of telephone calls with an internal or external tobacco coach to address smoking cessation	at 3 months and at 6 months after enrollment

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Partners HealthCare, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 2015P000002/MGH