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| Name | Class |
|---|---|
| Partners HealthCare, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Tobacco abstinence for the past 30 days | 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco abstinence for the past 30 days | 3 months after enrollment | |
| Tobacco abstinence for the past 30 days | 12 months after enrollment | |
| Quit attempt |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Smoking cessation counseling contacts |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy A Rigotti, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| External tobacco coach | Behavioral | Referral to Massachusetts Smokers Helpline (telephone quitline operated by the Massachusetts Tobacco Control Program) for proactive telephone counseling. |
|
| Intentional tobacco abstinence for at least 24 hours since enrollment |
Number of telephone calls with an internal or external tobacco coach to address smoking cessation
| at 3 months and at 6 months after enrollment |
| D001523 |
| Mental Disorders |