Offering Proactive Tobacco Treatment

Not Applicable

Completed

• Conditions: Tobacco Use Cessation
• Interventions: Other: proactive outreach (PRO); Other: Usual care (UC); Other: telephone counseling (TC); Other: Nicotine replacement therapy (NRT)

• Registration Number: NCT01123967
• Lead Sponsor: University of Minnesota

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 Timeline

• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Study Start: 2011-02
• Primary Completion: 2014-02
• Study Completion: 2014-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRO+NRT+TC	proactive outreach (PRO)	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)
Usual Care (UC)	Usual care (UC)	Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray
PRO+NRT+TC	telephone counseling (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)
PRO+NRT+TC	Nicotine replacement therapy (NRT)	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)

Primary Outcome Measures

Name	Time	Method
Results in Abstinence Rates	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 Outcome Measures

Name	Time	Method
Cost-Effectiveness of Program	1 Year	Determine the cost-effectiveness of PRO+NRT+TC compared with UC.
Results in Treatment Utilization	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 tobacco treatment utilization rates among a diverse population of low income smokers.

Trial Locations

Locations (1)

Steven Fu, M.D.; 🇺🇸 Minneapolis, Minnesota, United States