An interventional study of Internal tobacco coach and External tobacco coach in Smoking Cessation and Tobacco Use Disorder, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 127 are open to participants now.
This study's enrollment of 106 is above the median of 90 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Massachusetts General Hospital is the lead sponsor of 2,537 studies on the registry; 447 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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
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.
Referral to Massachusetts Smokers Helpline (telephone quitline operated by the Massachusetts Tobacco Control Program) for proactive telephone counseling.
Tobacco abstinence for the past 30 days
Time frame: 6 months after enrollment
Tobacco abstinence for the past 30 days
Time frame: 3 months after enrollment
Tobacco abstinence for the past 30 days
Time frame: 12 months after enrollment
Quit attempt
Time frame: Intentional tobacco abstinence for at least 24 hours since enrollment
Duration of use of tobacco cessation pharmacotherapy
Includes any FDA-approved product (nicotine patch, gum, lozenge, inhaler, nasal spray or bupropion or varenicline
Time frame: at 3 months and at 6 months after enrollment
Smoking cessation counseling contacts
Number of telephone calls with an internal or external tobacco coach to address smoking cessation
Time frame: at 3 months and at 6 months after enrollment
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital