Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers
![]() |
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: NCT01691105 |
Recruitment Status :
Completed
First Posted : September 24, 2012
Results First Posted : November 23, 2018
Last Update Posted : September 5, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|
![]() |
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 | |
---|---|---|---|---|
![]() |
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 | |
![]() |
[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%
|
Name/Title: | Dr. Steven Bernstein |
Organization: | Yale School of Medicine |
Phone: | 203-737-3574 |
EMail: | steven.bernstein@yale.edu |
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 |