Offering Proactive Tobacco Treatment

University of Minnesota (UMN)

Status: Completed

Conditions: Tobacco Use Cessation

Treatments: Other: Usual care (UC); Other: telephone counseling (TC); Other: Nicotine replacement therapy (NRT); Other: proactive outreach (PRO)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01123967

1R01CA141527 (U.S. NIH Grant/Contract)

2009NTLS064

0909S72235 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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

Enrollment: 2,500 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,500 participants in 2 patient groups

PRO+NRT+TC

Experimental group

Description:

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)

Treatment:

Other: Nicotine replacement therapy (NRT)

Other: proactive outreach (PRO)

Other: telephone counseling (TC)

Usual Care (UC)

Active Comparator group

Description:

Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray

Treatment:

Other: Usual care (UC)