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Helping Hospitalized Patients Quit Smoking

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.
 
ClinicalTrials.gov Identifier: NCT01575145
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
David Warner, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE April 9, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date January 11, 2016
Study Start Date  ICMJE May 2012
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
7-day point prevalence tobacco abstinence at 6 months after hospitalization [ Time Frame: 6 months after hospitalization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Self-efficacy [ Time Frame: Immediately after the delivery of the brief intervention (day of enrollment) ]
Use of Smoking Self-Efficacy Questionnaire 12
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Helping Hospitalized Patients Quit Smoking
Official Title  ICMJE Helping Hospitalized Patients Quit Smoking
Brief Summary

The study is being done to determine whether an in-hospital intervention using a brief intervention to facilitate quitline utilization will increase quitline utilization by hospitalized smokers, and will increase post hospital discharge smoking abstinence rates.

Study participants will be randomized to receive either a brief quitline facilitation intervention , or a control intervention of a brief stop-smoking message.

The study will also compare healthcare costs and utilization in the first six months following hospitalization between the two groups.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Abuse Cigarette
Intervention  ICMJE
  • Behavioral: Quitline facilitation intervention
    brief quitline facilitation intervention
  • Behavioral: Brief stop-smoking intervention
    brief review of tips to help maintain smoking abstinence, using brochure
Study Arms  ICMJE
  • Experimental: Quitline facilitation intervention
    brief quitline facilitation intervention given
    Intervention: Behavioral: Quitline facilitation intervention
  • Active Comparator: Stop-smoking intervention
    brief review of tips to maintain smoking abstinence, using brochure
    Intervention: Behavioral: Brief stop-smoking intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2012)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Current smoker, Resident of Olmsted County, Inpatient admission to St. Marys or Rochester Methodist Hospital, Able to participate fully in all study aspects, Available for follow-up

Exclusion Criteria:

Current active treatment for tobacco use initiated prior to hospitalization

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575145
Other Study ID Numbers  ICMJE 12-002207
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Warner, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Warner, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP