NCT01063972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
606

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

April 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

4.9 years

First QC Date

February 4, 2010

Results QC Date

March 12, 2019

Last Update Submit

April 4, 2019

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With 7-day Point Prevalence Abstinence From Cigarettes, Validated

    Participant-reported 7-day point prevalence abstinence from cigarettes, validated by salivary cotinine (\< 15ng/ml) or proxy. Participants who did not respond to the survey were considered current smokers.

    12 months

Secondary Outcomes (5)

  • Number of Participants With 7-day Point Prevalence Abstinence at 3 Months, Self-reported

    3 months

  • Number of Participants With 7-day Point Prevalence Abstinence at 6 Months, Self-reported

    6 months

  • Number of Participants With 7-day Point Prevalence Abstinence at 12 Months, Self-reported

    12 months

  • Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy During First 6 Months

    6 months

  • Number of Participants Reporting Utilization of Smoking Cessation Pharmacotherapy Between 6 and 12 Months

    12 months

Study Arms (2)

Experimental 1

EXPERIMENTAL

Experimental: 1 Centralized disease management

Behavioral: Centralized disease management (CDM)

Experimental 2

EXPERIMENTAL

Experimental: 2 Counseling alone

Behavioral: Counseling (C)

Interventions

Centralized disease management (CDM)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 1
Counseling (C)BEHAVIORAL

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

Experimental 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Terminal medical condition with life expectancy \<1 year
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Ellerbeck EF, Cox LS, Hui SA, Keighley J, Hutcheson TD, Fitzgerald SA, Cupertino AP, Greiner KA, Rigotti NA, Miller NH, Rabius V, Richter KP. Impact of Adding Telephone-Based Care Coordination to Standard Telephone-Based Smoking Cessation Counseling Post-hospital Discharge: a Randomized Controlled Trial. J Gen Intern Med. 2019 Dec;34(12):2804-2811. doi: 10.1007/s11606-019-05220-2. Epub 2019 Jul 31.

    PMID: 31367875DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Counseling

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Sharon Fitzgerald, MPH
Organization
University of Kansas Medical Center
sfitzgerald@kumc.edu
913-588-3488

Study Officials

  • Edward Ellerbeck, MD, MPH

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Chairman Preventive Medicine

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 8, 2019

Results First Posted

April 8, 2019

Record last verified: 2019-04

Locations

US(1)