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Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans

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ClinicalTrials.gov Identifier: NCT00816036
Recruitment Status : Completed
First Posted : December 31, 2008
Results First Posted : August 6, 2014
Last Update Posted : April 27, 2015
Sponsor:
Collaborators:
National Jewish Hospital Quitline
Iowa State University
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Cigarette Smoking
Intervention Behavioral: Smoking Cessation Guideline Implementation
Enrollment 898
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pre-intervention Period Intervention Period
Hide Arm/Group Description Pre-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

Period Title: Overall Study
Started 503 395
Completed 327 287
Not Completed 176 108
Reason Not Completed
Death             47             28
Lost to Follow-up             75             57
Withdrawal by Subject             54             23
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description Pre-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

Total of all reporting groups
Overall Number of Baseline Participants 503 395 898
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 503 participants 395 participants 898 participants
59.4  (9.7) 58.8  (10.2) 59.1  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 503 participants 395 participants 898 participants
Female
23
   4.6%
13
   3.3%
36
   4.0%
Male
480
  95.4%
382
  96.7%
862
  96.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 503 participants 395 participants 898 participants
503 395 898
1.Primary Outcome
Title 7-day Point-prevalence Smoking Abstinence (6-month)
Hide Description This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.
Time Frame 6 months post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This is the total number of subjects who completed 6 month follow-up (complete case analysis).
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Pre-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

Overall Number of Participants Analyzed 498 394
Measure Type: Number
Unit of Measure: participants
69 53
2.Secondary Outcome
Title Referrals to Quitline
Hide Description [Not Specified]
Time Frame Assessed within 72 hours of hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Pre-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

Overall Number of Participants Analyzed 498 394
Measure Type: Number
Unit of Measure: participants
0 36
3.Secondary Outcome
Title Prescription of Recommended Pharmacotherapy for Smoking Cessation
Hide Description [Not Specified]
Time Frame Assessed within 72 hours of hospital discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Pre-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

Overall Number of Participants Analyzed 498 394
Measure Type: Number
Unit of Measure: participants
176 149
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description Pre-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

All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/503 (0.00%)   0/395 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/503 (0.00%)   0/395 (0.00%) 
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
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00816036     History of Changes
Obsolete Identifiers: NCT00962858
Other Study ID Numbers: IIR 07-113
First Submitted: December 29, 2008
First Posted: December 31, 2008
Results First Submitted: July 8, 2014
Results First Posted: August 6, 2014
Last Update Posted: April 27, 2015