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

NCT02601521 | Completed

• 1 other identifier: 2015P000002/MGH
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Tobacco abstinence for the past 30 days

  6 months after enrollment

Secondary Outcomes (3)

• 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 Outcomes (2)

• Duration of use of tobacco cessation pharmacotherapy

  at 3 months and at 6 months after enrollment

• Smoking cessation counseling contacts

  at 3 months and at 6 months after enrollment

Study Arms (2)

Internal coaching program

EXPERIMENTAL

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

External coaching program

ACTIVE COMPARATOR

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

Interventions

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: 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.

Internal coaching program

External tobacco coach BEHAVIORAL

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

External coaching program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Partners HealthCare, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Nancy A Rigotti, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 10, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

US (1)