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

Smoking Cessation Clinical Trial

— PiHQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601521
• Other study ID #: 2015P000002/MGH
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 2020

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Use Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Partners HealthCare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Tobacco abstinence for the past 30 days		6 months after enrollment
Secondary	Tobacco abstinence for the past 30 days		3 months after enrollment
Secondary	Tobacco abstinence for the past 30 days		12 months after enrollment
Secondary	Quit attempt		Intentional tobacco abstinence for at least 24 hours since enrollment