Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

• 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: Yale University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Academic Detailing (AD)	AD + Integrated Tobacco Order Set
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

Baseline Characteristics

Arm/Group Title		Academic Detailing (AD)	AD + Integrated Tobacco Order Set	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Includes only participants who completed 1 month follow-up appointment.

Arm/Group Title	Academic Detailing (AD)	AD + Integrated Tobacco Order Set
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Academic Detailing (AD)	AD + Integrated Tobacco Order Set
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Academic Detailing (AD)	AD + Integrated Tobacco Order Set
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Academic Detailing (AD)	AD + Integrated Tobacco Order Set
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Academic Detailing (AD)	AD + Integrated Tobacco Order Set
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%

Adverse Events

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
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
Serious Adverse Events
	Academic Detailing (AD)	AD + Integrated Tobacco Order Set
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Dr. Steven Bernstein
• Organization: Yale School of Medicine
• Phone: 203-737-3574
• EMail: steven.bernstein@yale.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bernstein SL, Weiss J, DeWitt M, Tetrault JM, Hsiao AL, Dziura J, Sussman S, Miller T, Carpenter K, O'Connor P, Toll B. A randomized trial of decision support for tobacco dependence treatment in an inpatient electronic medical record: clinical results. Implement Sci. 2019 Jan 22;14(1):8. doi: 10.1186/s13012-019-0856-8.

Bernstein SL, Rosner J, DeWitt M, Tetrault J, Hsiao AL, Dziura J, Sussman S, O'Connor P, Toll B. Design and implementation of decision support for tobacco dependence treatment in an inpatient electronic medical record: a randomized trial. Transl Behav Med. 2017 Jun;7(2):185-195. doi: 10.1007/s13142-017-0470-8.

• 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