Smoking Cessation in Rural Hospitals

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-02-28

Brief Summary

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Our long-term goal is to improve smoking cessation treatment for rural smokers. The objective is to assess the effectiveness of a centralized disease management program for hospitalized smokers that coordinates care across treatment settings and links smokers to existing resources. Our central hypothesis is that Centralized Disease Management (CDM) will increase the use of smoking cessation treatments and lead to greater long term smoking cessation than Counseling alone. Demonstrating the effectiveness of a disease management program and identifying the critical components of such a program will provide a basis for improving the utilization of existing smoking cessation resources while enhancing the treatment of rural hospitalized smokers.

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Detailed Description

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The proposed study will use a randomized clinical trial design to examine the effectiveness of centralized disease management (CDM) versus counseling alone (C) for smoking cessation. Hospitalized smokers in 30 rural critical access hospitals will be randomly assigned to either CDM (n=303) or C (n=303). Participants in both arms of the study will receive in-hospital smoking cessation counseling via telephone followed by 4 outpatient telephone-based counseling calls. The content and timing of these counseling calls are designed to emulate models of smoking cessation counseling that have been previously shown to be effective for hospitalized smokers. For recipients assigned to CDM, the counseling will be streamlined to allow time on the calls for specific disease management interventions, including screening for contraindications to pharmacotherapy and linking medication choices to the smoker's insurance coverage. After completing calls with CDM participants, the Tobacco Treatment Specialists will coordinate therapy with the patient's health care providers by providing them with brief consultation reports, prepared order sheets for inpatient treatment, and outpatient prescription requests. Six months postdischarge, participants in both groups will be contacted again, and persistent or relapsed smokers will be offered another cycle of the C or CDM intervention.

Assessments will be conducted at baseline and at months 3, 6, and 12. The primary outcome of interest will be biochemically verified 7-day point prevalence abstinence at 12 months. Secondary endpoints include number of quit attempts and number of cigarettes smoked (among continuing smokers), pharmacotherapy utilization, duration of pharmacotherapy utilization, and the extent of discussions with the healthcare provider. We will also examine the marginal cost-effectiveness of the intervention.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental 1

Experimental: 1 Centralized disease management

Group Type EXPERIMENTAL

Centralized disease management (CDM)

Intervention Type BEHAVIORAL

Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider

Experimental 2

Experimental: 2 Counseling alone

Group Type EXPERIMENTAL

Counseling (C)

Intervention Type BEHAVIORAL

Counseling (C) arm will receive counseling without the care coordination services.

Interventions

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Centralized disease management (CDM)

Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider

Intervention Type BEHAVIORAL

Counseling (C)

Counseling (C) arm will receive counseling without the care coordination services.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Hospitalized in a participating rural hospital
* Aged 18 years or older
* Smoke cigarettes on \>25 of the last 30 days
* Have a home address and telephone
* Willing to participate in phone assessments