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Centralized Disease Management for Rural Hospitalized Smokers

18 Years
Open (Enrolling)
Smoking Cessation

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Trial Information

Centralized Disease Management for Rural Hospitalized Smokers

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.

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

Exclusion Criteria:

- Terminal medical condition with life expectancy <1 year

- Pregnant

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

7-day point prevalence abstinence from cigarettes

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Edward Ellerbeck, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Institutional Review Board

Study ID:

5 R01 CA101963-07



Start Date:

March 2010

Completion Date:

January 2014

Related Keywords:

  • Smoking Cessation
  • Smoking



University of Kansas Medical Center Kansas City, Kansas  66160-7353