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| ID | Type | Description | Link |
|---|---|---|---|
| R18HL108788 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institutes of Health (NIH) | NIH |
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This study will implement and test the effectiveness and cost-effectiveness of a tobacco cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for adults admitted to the hospital. The intervention will begin during the hospital stay and continue after discharge. The intervention will use resources easily available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL).
The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self report and biochemical verification (exhaled carbon monoxide reading).
Cigarette smoking remains the leading cause of preventable death and illness in the United States. In 2008, 20.6% of all American adults smoked, and 435,000 died from smoking-related illnesses. Economic costs of smoking dependence are estimated at $193 billion/year and have far-reaching implications for the individual, workplace, society and the healthcare system. However, treatment is associated with significant individual and society benefits, and both counseling and pharmacotherapy have been demonstrated to be effective treatments. Along with poverty and low education, smoking causes a greater loss of quality-adjusted life years than race, uninsurance, overweight, or binge drinking.
Smokers are admitted to acute care hospital more than nonsmokers. Using estimates from a number of sources, we estimate that approximately 6.1-12.5 million hospitalizations occur annually among adult smokers. This represents 20-41% of the 29.8 million annual inpatient stays in US acute care hospitals among adults age 18 and older unrelated to pregnancy or childbirth. Put another way, the nation's 46 million smokers represent 20% of the adult population, but account for 20-40% of all hospitalizations unrelated to pregnancy. Given that US hospitals are now smoke-free (per Joint Commission regulations), and many of these admissions are for tobacco-related conditions, the hospital admission represents a profound opportunity-a "teachable moment"-for tobacco control.
Recent "core measure" regulations by the Joint Commission and the Centers for Medicare and Medicaid Services require hospitals to report publicly their tobacco screening for patients admitted with acute myocardial infarction, congestive heart failure, and pneumonia. Although many hospitals have improved their performance considerably on these smoking measures, sometimes this has resulted from "gaming," e.g. giving all discharged patients a preprinted instruction sheet that includes boilerplate text about smoking cessation. Thus, although most hospitals assess inpatients for tobacco use (either through a nursing assessment or the physician's initial history and physical examination), there are often no systems in place to initiate or sustain tobacco treatment for smokers. This gap in service delivery prevents millions of smokers from accessing the many effective, evidence-based treatments for tobacco dependence during a period in which they may be particularly receptive to an intervention.
Hence, the overarching goal of this project is to implement and study the effectiveness and cost-effectiveness of a tobacco intervention for hospitalized adults that begins during inpatient treatment and continues after discharge. To enhance dissemination, we will use resources currently available to most acute care hospitals: computerized physician order entry, physician and nurse education, staff meetings for physicians, nurses, and allied health professionals, online learning capabilities, faxing to primary care providers (PCPs), and the telephone counseling and support available from a state smokers' quitline (QL). In the final year, a toolkit will be disseminated by professional societies. We hypothesize that the proposed intervention is clinically effective, cost effective, sustainable, and generalizable. All interventions are evidence-based and consistent with the 2008 Public Health Service clinical practice guideline for tobacco dependence treatment.
The Specific Aims of the proposed project are to:
Primary Aims:
Determine whether Academic Detailing (AD) and an Integrated Tobacco Order Set (ITOS) compared to AD alone improves biologically verified smoking cessation at 12 months post-quit in a cohort of 960 smokers age > 18 years admitted to Yale New Haven Hospital (YNHH).
Secondary Aims:
Study ITOS's ability to encourage smokers to use treatment services and reduce consumption.
Study ITOS's ability to enhance provider delivery of tobacco screening and treatment.
Conduct an incremental cost-effectiveness analysis of the intervention.
Our associated hypotheses are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Academic Detailing (AD) | No Intervention | Standard of care for patients who are smokers and admitted to the hospital. | |
| AD + Integrated Tobacco Order Set | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD + Integrated Tobacco Order Set | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence | 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. | 12 months post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months | 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. | 12 months post enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L Bernstein, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30670043 | Derived | 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. | |
| 28194729 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Academic Detailing (AD) | Standard of care for patients who are smokers and admitted to the hospital. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 1 Month Follow-up |
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| 6 Month Follow-up |
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| 12 Month Follow-up |
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| 12 Month Biochemical Verification |
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| ID | Title | Description |
|---|---|---|
| BG000 | Academic Detailing (AD) | Standard of care for patients who are smokers and admitted to the hospital. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence | 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. | Only participants self-reporting abstinence during the 12 month follow-up call were asked to provide biochemical verification. | Posted | Number | participants | 12 months post enrollment |
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Academic Detailing (AD) | Standard of care for patients who are smokers and admitted to the hospital. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Bernstein | Yale School of Medicine | 203-737-3574 | steven.bernstein@yale.edu |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months |
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. |
| 6 months post enrollment |
| Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month | 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. | 1 month post enrollment |
| Number of Participants Self-Reporting Use of Cessation Medications - 1 Month | 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. | 1 month post enrollment |
| Number of Participants Self-Reporting Use of Cessation Medications - 6 Months | 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. | 6 months post enrollment |
| Number of Participants Self-Reporting Use of Cessation Medications - 12 Months | 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. | 12 months post enrollment |
| Number of Participants Self-Reporting Treatment Engagement - 1 Month | 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. | 1 month post enrollment |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cigarettes/day | Median | Inter-Quartile Range | cigarettes per day |
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| Heavy Smoking Index >= 4, N (%) | Count of Participants | Participants |
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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
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| Secondary | Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months | 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. | Only includes participants who completed the 12 month follow-up appointment. | Posted | Number | participants | 12 months post enrollment |
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| Secondary | Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months | 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. | Includes only participants who completed the 6 month follow-up appointment. | Posted | Number | participants | 6 months post enrollment |
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| Secondary | Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month | 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. | Includes only participants who completed 1 month follow-up appointment. | Posted | Number | participants | 1 month post enrollment |
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| Secondary | Number of Participants Self-Reporting Use of Cessation Medications - 1 Month | 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. | Posted | Count of Participants | Participants | 1 month post enrollment |
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| Secondary | Number of Participants Self-Reporting Use of Cessation Medications - 6 Months | 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. | Posted | Count of Participants | Participants | 6 months post enrollment |
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| Secondary | Number of Participants Self-Reporting Use of Cessation Medications - 12 Months | 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. | Posted | Count of Participants | Participants | 12 months post enrollment |
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| Secondary | Number of Participants Self-Reporting Treatment Engagement - 1 Month | 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. | Posted | Count of Participants | Participants | 1 month post enrollment |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001523 |
| Mental Disorders |