Smoking Cessation in Rural Hospitals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01063972
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : April 21, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Edward Ellerbeck, MD, MPH, University of Kansas Medical Center Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Centralized disease management (CDM) Behavioral: Counseling (C) Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 606 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Centralized Disease Management for Rural Hospitalized Smokers
Study Start Date : March 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental 1
Experimental: 1 Centralized disease management
Behavioral: 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
Experimental: Experimental 2
Experimental: 2 Counseling alone
Behavioral: Counseling (C)
Counseling (C) arm will receive counseling without the care coordination services.

Primary Outcome Measures :
  1. 7-day point prevalence abstinence from cigarettes [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of quit attempts [ Time Frame: 3, 6, and 12 months ]
  2. Utilization of smoking cessation pharmacotherapy [ Time Frame: 3, 6, and 12 months ]
  3. Duration of pharmacotherapy treatment [ Time Frame: 3, 6, 12 months ]
  4. Extent of discussions with healthcare providers [ Time Frame: 3, 6, and 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01063972

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Edward Ellerbeck, MD, MPH
National Cancer Institute (NCI)
Principal Investigator: Edward Ellerbeck, MD, MPH University of Kansas Medical Center

Responsible Party: Edward Ellerbeck, MD, MPH, Professor, Chairman Preventive Medicine, University of Kansas Medical Center Research Institute Identifier: NCT01063972     History of Changes
Other Study ID Numbers: 5R01CA101963-07 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015