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Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

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ClinicalTrials.gov Identifier: NCT01691105
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : November 23, 2018
Last Update Posted : September 5, 2021
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Tobacco Use Cessation
Smoking Cessation
Smoking
Tobacco Use Disorder
Intervention Other: AD + Integrated Tobacco Order Set
Enrollment 1044
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Period Title: Baseline
Started 477 567
Completed 477 567
Not Completed 0 0
Period Title: 1 Month Follow-up
Started 477 567
Completed 434 526
Not Completed 43 41
Reason Not Completed
Lost to Follow-up             41             38
Death             2             3
Period Title: 6 Month Follow-up
Started 477 567
Completed 425 496
Not Completed 52 71
Reason Not Completed
Lost to Follow-up             39             58
Death             13             13
Period Title: 12 Month Follow-up
Started 477 567
Completed 405 466
Not Completed 72 101
Reason Not Completed
Lost to Follow-up             50             71
Death             22             30
Period Title: 12 Month Biochemical Verification
Started 477 567
Completed 53 65
Not Completed 424 502
Reason Not Completed
Death             22             30
Lost to Follow-up             50             71
subject did not self-report abstinence             352             401
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set Total
Hide Arm/Group Description Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Total of all reporting groups
Overall Number of Baseline Participants 477 567 1044
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 477 participants 567 participants 1044 participants
49.3  (12.6) 49.3  (11.7) 49.3  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 477 participants 567 participants 1044 participants
Female
238
  49.9%
286
  50.4%
524
  50.2%
Male
239
  50.1%
281
  49.6%
520
  49.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 477 participants 567 participants 1044 participants
Hispanic or Latino
51
  10.7%
61
  10.8%
112
  10.7%
Not Hispanic or Latino
426
  89.3%
506
  89.2%
932
  89.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 477 participants 567 participants 1044 participants
American Indian or Alaska Native
4
   0.8%
1
   0.2%
5
   0.5%
Asian
2
   0.4%
3
   0.5%
5
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
157
  32.9%
170
  30.0%
327
  31.3%
White
303
  63.5%
372
  65.6%
675
  64.7%
More than one race
11
   2.3%
18
   3.2%
29
   2.8%
Unknown or Not Reported
0
   0.0%
3
   0.5%
3
   0.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 477 participants 567 participants 1044 participants
477 567 1044
Cigarettes/day  
Median (Inter-Quartile Range)
Unit of measure:  Cigarettes per day
Number Analyzed 477 participants 567 participants 1044 participants
10.0
(8 to 20)
10.5
(8 to 20)
10.0
(8 to 20)
Heavy Smoking Index >= 4, N (%)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 477 participants 567 participants 1044 participants
208
  43.6%
210
  37.0%
418
  40.0%
1.Primary Outcome
Title Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence
Hide Description Tobacco abstinence will be assessed by obtaining an exhaled carbon monoxide reading for all subjects self-reporting tobacco abstinence at 12 month follow-up. Consistent with manufacturer's recommendations, a cutoff of 10 ppm will indicate current smoking.
Time Frame 12 months post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants self-reporting abstinence during the 12 month follow-up call were asked to provide biochemical verification.
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description:
Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Overall Number of Participants Analyzed 78 86
Measure Type: Number
Unit of Measure: participants
53 65
2.Secondary Outcome
Title Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months
Hide Description Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.
Time Frame 12 months post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Only includes participants who completed the 12 month follow-up appointment.
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description:
Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Overall Number of Participants Analyzed 405 466
Measure Type: Number
Unit of Measure: participants
78 86
3.Secondary Outcome
Title Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months
Hide Description Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.
Time Frame 6 months post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Includes only participants who completed the 6 month follow-up appointment.
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description:
Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Overall Number of Participants Analyzed 425 496
Measure Type: Number
Unit of Measure: participants
68 83
4.Secondary Outcome
Title Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month
Hide Description Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.
Time Frame 1 month post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Includes only participants who completed 1 month follow-up appointment.
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description:
Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Overall Number of Participants Analyzed 434 526
Measure Type: Number
Unit of Measure: participants
72 87
5.Secondary Outcome
Title Number of Participants Self-Reporting Use of Cessation Medications - 1 Month
Hide Description Nicotine replacement therapy (NRT) use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.
Time Frame 1 month post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description:
Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Overall Number of Participants Analyzed 434 526
Measure Type: Count of Participants
Unit of Measure: Participants
126
  29.0%
187
  35.6%
6.Secondary Outcome
Title Number of Participants Self-Reporting Use of Cessation Medications - 6 Months
Hide Description NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 6 months post enrollment.
Time Frame 6 months post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description:
Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Overall Number of Participants Analyzed 425 496
Measure Type: Count of Participants
Unit of Measure: Participants
100
  23.5%
146
  29.4%
7.Secondary Outcome
Title Number of Participants Self-Reporting Use of Cessation Medications - 12 Months
Hide Description NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.
Time Frame 12 months post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description:
Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Overall Number of Participants Analyzed 405 466
Measure Type: Count of Participants
Unit of Measure: Participants
100
  24.7%
136
  29.2%
8.Secondary Outcome
Title Number of Participants Self-Reporting Treatment Engagement - 1 Month
Hide Description Treatment engagement will be assessed by subject self-report during the 1 month follow-up interview. Subjects will be considered engaged in treatment if at 30 days after randomization the subject reports currently receiving care for the Quitline or another treatment program that addresses the subject's nicotine dependence.
Time Frame 1 month post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description:
Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

Overall Number of Participants Analyzed 434 526
Measure Type: Count of Participants
Unit of Measure: Participants
32
   7.4%
80
  15.2%
Time Frame [Not Specified]
Adverse Event Reporting Description All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
 
Arm/Group Title Academic Detailing (AD) AD + Integrated Tobacco Order Set
Hide Arm/Group Description Standard of care for patients who are smokers and admitted to the hospital.

Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

AD + Integrated Tobacco Order Set: Physician will have access to:

NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center

All-Cause Mortality
Academic Detailing (AD) AD + Integrated Tobacco Order Set
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Academic Detailing (AD) AD + Integrated Tobacco Order Set
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Academic Detailing (AD) AD + Integrated Tobacco Order Set
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Steven Bernstein
Organization: Yale School of Medicine
Phone: 203-737-3574
EMail: steven.bernstein@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01691105    
Other Study ID Numbers: 1205010297
R18HL108788 ( U.S. NIH Grant/Contract )
First Submitted: September 19, 2012
First Posted: September 24, 2012
Results First Submitted: September 17, 2018
Results First Posted: November 23, 2018
Last Update Posted: September 5, 2021