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

Not Applicable

Completed

• Conditions: Tobacco Use Disorder; Smoking Cessation
• Interventions: Behavioral: External tobacco coach; Behavioral: Internal tobacco coach

• Registration Number: NCT02601521
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-10
• Primary Completion: 2019-09
• Study Completion: 2020-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External coaching program	External tobacco coach	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.
Internal coaching program	Internal tobacco coach	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.

Primary Outcome Measures

Name	Time	Method
Tobacco abstinence for the past 30 days	6 months after enrollment

Secondary Outcome Measures

Name	Time	Method
Tobacco abstinence for the past 30 days	12 months after enrollment
Quit attempt	Intentional tobacco abstinence for at least 24 hours since enrollment

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States