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

NCT ID: NCT02601521

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-03-31

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.

Conditions

Smoking Cessation; Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Internal tobacco coach

Intervention Type: 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:

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.

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.

Group Type: ACTIVE_COMPARATOR

External tobacco coach

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

External tobacco coach

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Partners HealthCare, Inc.

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nancy A. Rigotti

Professor of Medicine, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy A Rigotti, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2015P000002/MGH

Identifier Type: -

Identifier Source: org_study_id