Trial Outcomes & Findings for Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers (NCT NCT01691105)
NCT ID: NCT01691105
Last Updated: 2021-09-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1044 participants
Primary outcome timeframe
12 months post enrollment
Results posted on
2021-09-05
Participant Flow
Participant milestones
| Measure |
Academic Detailing (AD)
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
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
|
|---|---|---|
|
Baseline
STARTED
|
477
|
567
|
|
Baseline
COMPLETED
|
477
|
567
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
1 Month Follow-up
STARTED
|
477
|
567
|
|
1 Month Follow-up
COMPLETED
|
434
|
526
|
|
1 Month Follow-up
NOT COMPLETED
|
43
|
41
|
|
6 Month Follow-up
STARTED
|
477
|
567
|
|
6 Month Follow-up
COMPLETED
|
425
|
496
|
|
6 Month Follow-up
NOT COMPLETED
|
52
|
71
|
|
12 Month Follow-up
STARTED
|
477
|
567
|
|
12 Month Follow-up
COMPLETED
|
405
|
466
|
|
12 Month Follow-up
NOT COMPLETED
|
72
|
101
|
|
12 Month Biochemical Verification
STARTED
|
477
|
567
|
|
12 Month Biochemical Verification
COMPLETED
|
53
|
65
|
|
12 Month Biochemical Verification
NOT COMPLETED
|
424
|
502
|
Reasons for withdrawal
| Measure |
Academic Detailing (AD)
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
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
|
|---|---|---|
|
1 Month Follow-up
Lost to Follow-up
|
41
|
38
|
|
1 Month Follow-up
Death
|
2
|
3
|
|
6 Month Follow-up
Lost to Follow-up
|
39
|
58
|
|
6 Month Follow-up
Death
|
13
|
13
|
|
12 Month Follow-up
Lost to Follow-up
|
50
|
71
|
|
12 Month Follow-up
Death
|
22
|
30
|
|
12 Month Biochemical Verification
Death
|
22
|
30
|
|
12 Month Biochemical Verification
Lost to Follow-up
|
50
|
71
|
|
12 Month Biochemical Verification
subject did not self-report abstinence
|
352
|
401
|
Baseline Characteristics
Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers
Baseline characteristics by cohort
| Measure |
Academic Detailing (AD)
n=477 Participants
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
n=567 Participants
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
n=1044 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
238 Participants
n=5 Participants
|
286 Participants
n=7 Participants
|
524 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
520 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
426 Participants
n=5 Participants
|
506 Participants
n=7 Participants
|
932 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
157 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
303 Participants
n=5 Participants
|
372 Participants
n=7 Participants
|
675 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
477 participants
n=5 Participants
|
567 participants
n=7 Participants
|
1044 participants
n=5 Participants
|
|
Cigarettes/day
|
10.0 cigarettes per day
n=5 Participants
|
10.5 cigarettes per day
n=7 Participants
|
10.0 cigarettes per day
n=5 Participants
|
|
Heavy Smoking Index >= 4, N (%)
|
208 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months post enrollmentPopulation: Only participants self-reporting abstinence during the 12 month follow-up call were asked to provide biochemical verification.
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.
Outcome measures
| Measure |
Academic Detailing (AD)
n=78 Participants
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
n=86 Participants
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
|
|---|---|---|
|
Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence
|
53 participants
|
65 participants
|
SECONDARY outcome
Timeframe: 12 months post enrollmentPopulation: Only includes participants who completed the 12 month follow-up appointment.
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.
Outcome measures
| Measure |
Academic Detailing (AD)
n=405 Participants
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
n=466 Participants
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
|
|---|---|---|
|
Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months
|
78 participants
|
86 participants
|
SECONDARY outcome
Timeframe: 6 months post enrollmentPopulation: Includes only participants who completed the 6 month follow-up appointment.
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.
Outcome measures
| Measure |
Academic Detailing (AD)
n=425 Participants
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
n=496 Participants
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
|
|---|---|---|
|
Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months
|
68 participants
|
83 participants
|
SECONDARY outcome
Timeframe: 1 month post enrollmentPopulation: Includes only participants who completed 1 month follow-up appointment.
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.
Outcome measures
| Measure |
Academic Detailing (AD)
n=434 Participants
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
n=526 Participants
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
|
|---|---|---|
|
Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month
|
72 participants
|
87 participants
|
SECONDARY outcome
Timeframe: 1 month post enrollmentNicotine 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.
Outcome measures
| Measure |
Academic Detailing (AD)
n=434 Participants
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
n=526 Participants
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
|
|---|---|---|
|
Number of Participants Self-Reporting Use of Cessation Medications - 1 Month
|
126 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: 6 months post enrollmentNRT 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.
Outcome measures
| Measure |
Academic Detailing (AD)
n=425 Participants
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
n=496 Participants
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
|
|---|---|---|
|
Number of Participants Self-Reporting Use of Cessation Medications - 6 Months
|
100 Participants
|
146 Participants
|
SECONDARY outcome
Timeframe: 12 months post enrollmentNRT 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.
Outcome measures
| Measure |
Academic Detailing (AD)
n=405 Participants
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
n=466 Participants
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
|
|---|---|---|
|
Number of Participants Self-Reporting Use of Cessation Medications - 12 Months
|
100 Participants
|
136 Participants
|
SECONDARY outcome
Timeframe: 1 month post enrollmentTreatment 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.
Outcome measures
| Measure |
Academic Detailing (AD)
n=434 Participants
Standard of care for patients who are smokers and admitted to the hospital.
|
AD + Integrated Tobacco Order Set
n=526 Participants
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
|
|---|---|---|
|
Number of Participants Self-Reporting Treatment Engagement - 1 Month
|
32 Participants
|
80 Participants
|
Adverse Events
Academic Detailing (AD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AD + Integrated Tobacco Order Set
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place