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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02601521

Collaborator

Partners HealthCare, Inc. (Industry)

106

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

106 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.

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Tobacco abstinence for the past 30 days [6 months after enrollment]

Secondary Outcome Measures

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

Duration of use of tobacco cessation pharmacotherapy [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
Smoking cessation counseling contacts [at 3 months and at 6 months after enrollment]
Number of telephone calls with an internal or external tobacco coach to address smoking cessation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital
Partners HealthCare, Inc.

Investigators

Principal Investigator: Nancy A Rigotti, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nancy A. Rigotti, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT02601521

Other Study ID Numbers:

2015P000002/MGH

First Posted:

Nov 10, 2015

Last Update Posted:

Feb 24, 2021

Last Verified:

Feb 1, 2021

Additional relevant MeSH terms:

Tobacco Use Disorder

Study Results

No Results Posted as of Feb 24, 2021