Smoking Cessation, Tobacco Use Disorder
Conditions
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.
Interventions
BEHAVIORALInternal 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.
BEHAVIORALExternal tobacco coach
Referral to Massachusetts Smokers Helpline (telephone quitline operated by the Massachusetts Tobacco Control Program) for proactive telephone counseling.
Sponsors
Partners HealthCare, Inc.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tobacco abstinence for the past 30 days | 6 months after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Tobacco abstinence for the past 30 days | 3 months after enrollment |
| Quit attempt | Intentional tobacco abstinence for at least 24 hours since enrollment |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed