Offering Proactive Tobacco Treatment

Study Overview
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Brief Summary
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This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).

Detailed Description
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Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).

Official Title
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Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Other: proactive outreach (PRO)
* Other: telephone counseling (TC)
* Other: Nicotine replacement therapy (NRT)
* Other: Usual care (UC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must complete the baseline survey Current self-reported cigarette smoker Has a valid home address An adequate proficiency in English to complete study surveys and participate in telephone counseling. exclusion Criteria: adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO+NRT+TC<br>Proactive outreach (mailed invitation letter followed by telephone outreach) combined with free nicotine replacement therapy (NRT) and telephone counseling (PRO+NRT+TC)to usual care (UC) | Other: proactive outreach (PRO)<br>* a mailed invitation letter followed by telephone outreach<br>Other: telephone counseling (TC)<br>* free telephone counseling<br>Other: Nicotine replacement therapy (NRT)<br>* free nicotine replacement therapy (NRT)<br>|
| Active Comparator: Usual Care (UC)<br>Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray | Other: Usual care (UC)<br>* nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results in Abstinence Rates | Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results in Treatment Utilization | Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level tobacco treatment utilization rates among a diverse population of low income smokers. | 1 Year | 
| Cost-Effectiveness of Program | Determine the cost-effectiveness of PRO+NRT+TC compared with UC. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine replacement therapy, smoking cessation, tobacco dependent