Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 2,500
- Locations
- 1
- Primary Endpoint
- Results in Abstinence Rates
Study Overview
Brief Summary
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
Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
PRO+NRT+TC
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)
Intervention: proactive outreach (PRO) (Other)
PRO+NRT+TC
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)
Intervention: telephone counseling (TC) (Other)
Usual Care (UC)
Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray
Intervention: Usual care (UC) (Other)
PRO+NRT+TC
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)
Intervention: Nicotine replacement therapy (NRT) (Other)
Outcomes
Primary Outcomes
Results in Abstinence Rates
Time Frame: 1 Year
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.
Secondary Outcomes
- Cost-Effectiveness of Program(1 Year)
- Results in Treatment Utilization(1 Year)