Smoking Cessation in Rural Hospitals

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Edward Ellerbeck, MD, MPH, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01063972
First received: February 4, 2010
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention
Smoking Cessation
Behavioral: Centralized disease management (CDM)
Behavioral: Counseling (C)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Centralized Disease Management for Rural Hospitalized Smokers

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 7-day point prevalence abstinence from cigarettes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of quit attempts [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Utilization of smoking cessation pharmacotherapy [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Duration of pharmacotherapy treatment [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Extent of discussions with healthcare providers [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 606
Study Start Date: March 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063972

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Edward Ellerbeck, MD, MPH
Investigators
Principal Investigator: Edward Ellerbeck, MD, MPH University of Kansas
  More Information

No publications provided

Responsible Party: Edward Ellerbeck, MD, MPH, Professor, Chairman Preventive Medicine, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01063972     History of Changes
Other Study ID Numbers: 5 R01 CA101963-07, 5R01CA101963-07
Study First Received: February 4, 2010
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Smoking
Food Habits
Habits

ClinicalTrials.gov processed this record on July 31, 2014