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Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

This study has been completed.
Sponsor:
Collaborators:
National Jewish Hospital Quitline
Iowa State University
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00816036
First received: December 29, 2008
Last updated: April 6, 2015
Last verified: April 2014
Results First Received: July 8, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Cigarette Smoking
Intervention: Behavioral: Smoking Cessation Guideline Implementation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pre-intervention Period Pre-intervention Period
Intervention Period

Intervention Period

Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff


Participant Flow:   Overall Study
    Pre-intervention Period   Intervention Period
STARTED   503   395 
COMPLETED   327   287 
NOT COMPLETED   176   108 
Death                47                28 
Lost to Follow-up                75                57 
Withdrawal by Subject                54                23 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1 Pre-intervention Period
Arm 2

Intervention Period

Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff

Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 503   395   898 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.4  (9.7)   58.8  (10.2)   59.1  (9.9) 
Gender 
[Units: Participants]
     
Female   23   13   36 
Male   480   382   862 
Region of Enrollment 
[Units: Participants]
     
United States   503   395   898 


  Outcome Measures
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1.  Primary:   7-day Point-prevalence Smoking Abstinence (6-month)   [ Time Frame: 6 months post enrollment ]

2.  Secondary:   Referrals to Quitline   [ Time Frame: Assessed within 72 hours of hospital discharge ]

3.  Secondary:   Prescription of Recommended Pharmacotherapy for Smoking Cessation   [ Time Frame: Assessed within 72 hours of hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Katz, MD, MSc
Organization: Department of Veterans Affairs
phone: 319-338-0581 ext 7598
e-mail: david-katz@uiowa.edu


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00816036     History of Changes
Obsolete Identifiers: NCT00962858
Other Study ID Numbers: IIR 07-113
Study First Received: December 29, 2008
Results First Received: July 8, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government