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

Tracking Information

• First Submitted Date: September 19, 2012
• First Posted Date: September 24, 2012
• Results First Submitted Date: September 17, 2018
• Results First Posted Date: November 23, 2018
• Last Update Posted Date: September 5, 2021
• Study Start Date: August 2013
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2018)

Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence [ Time Frame: 12 months post enrollment ]

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.

Original Primary Outcome Measures (submitted: September 21, 2012)

Exhaled Carbon Monoxide reading [ Time Frame: 12 months post enrollment ]

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.

Current Secondary Outcome Measures (submitted: August 11, 2021)

• Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months [ Time Frame: 12 months post enrollment ]
  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.
• Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months [ Time Frame: 6 months post enrollment ]
  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.
• Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month [ Time Frame: 1 month post enrollment ]
  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.
• Number of Participants Self-Reporting Use of Cessation Medications - 1 Month [ Time Frame: 1 month post enrollment ]
  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.
• Number of Participants Self-Reporting Use of Cessation Medications - 6 Months [ Time Frame: 6 months post enrollment ]
  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.
• Number of Participants Self-Reporting Use of Cessation Medications - 12 Months [ Time Frame: 12 months post enrollment ]
  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.
• Number of Participants Self-Reporting Treatment Engagement - 1 Month [ Time Frame: 1 month post enrollment ]
  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.

Original Secondary Outcome Measures (submitted: September 21, 2012)

• Self-reported tobacco reduction or abstinence [ Time Frame: 1 month post enrollment ]
  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.
• Treatment engagement [ Time Frame: 1 month post enrollment ]
  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.
• Use of cessation medications and services [ Time Frame: 1 month post enrollment ]
  Quitline use, nicotine replacement therapy (NRT) use, use of other pharmacotherapies will be assessed by self-report and fax reports from the Quitline. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.
• Self-reported tobacco reduction or abstinence [ Time Frame: 6 months post enrollment ]
  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.
• Self-reported tobacco reduction or abstinence [ Time Frame: 12 months post enrollment ]
  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.
• Use of cessation medications and services [ Time Frame: 6 months post enrollment ]
  Quitline use, NRT use, use of other pharmacotherapies will be assessed by self-report and fax reports from the Quitline. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.
• Use of cessation medications and services [ Time Frame: 12 months post enrollment ]
  Quitline use, NRT use, use of other pharmacotherapies will be assessed by self-report and fax reports from the Quitline. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers
• Official Title: Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

Brief Summary

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).

Detailed Description

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:

1. 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:

2. Study ITOS's ability to encourage smokers to use treatment services and reduce consumption.
3. Study ITOS's ability to enhance provider delivery of tobacco screening and treatment.
4. Conduct an incremental cost-effectiveness analysis of the intervention.

Our associated hypotheses are:

1. Subjects treated by physicians in the AD+ITOS arm will have a higher rate of biochemically verified 7-day point prevalence smoking abstinence at 12 months post-quit than subjects treated by physicians in the AD arm, in a cohort of adult smokers admitted to the inpatient units of Yale-New Haven Hospital.
2. Subjects treated by AD+ITOS physicians will have made more quit attempts, and experienced greater reduction in daily cigarette consumption, than smokers treated by AD physicians.
3. A higher proportion of patients treated by AD+ITOS physicians will have tobacco treatment initiated in hospital than patients treated by AD physicians.
4. Societal costs of AD+ITOS, per abstinent smoker, will be cost-effective relative to AD.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment

Condition

• Tobacco Use Cessation
• Smoking Cessation
• Smoking
• Tobacco Use Disorder

Intervention

Other: 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

Study Arms

• No Intervention: Academic Detailing (AD)
  Standard of care for patients who are smokers and admitted to the hospital.
• Experimental: 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
  Intervention: Other: AD + Integrated Tobacco Order Set

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 11, 2016): 1044
• Original Estimated Enrollment (submitted: September 21, 2012): 960
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 18 years or older
• admitted to any medical ward, telemetry or cardiac care unit
• identified as a smoker by the nurse or physician in the admitting EMR
• treated by a study physician
• able to give written informed consent

Exclusion Criteria:

• inability to read or understand English or Spanish
• lacks capacity to give informed consent
• currently receiving formal tobacco dependence treatment
• current suicide or homicide risk
• current psychotic disorder or life-threatening or unstable medical or psychiatric condition within past 6 months
• unable to provide 2 telephone contact numbers
• unwilling to follow up per study protocol, including release of information to assess treatment engagement at 30-days
• live outside of New Haven County
• leaving the hospital against medical advice
• history of clinically significant allergic reaction to nicotine replacement therapies, varenicline or bupropion
• use of an investigational drug within 30 days
• use of tobacco products other than cigarettes
• women of childbearing potential who are pregnant, nursing, or sexually active and not practicing effective contraception (oral injectable, or implantable contraceptives, intrauterine device, or barrier method with spermicide)
• do not have access to a phone with a CT area code (required to use the CT Tobacco Quitline)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01691105
• Other Study ID Numbers: 1205010297; R18HL108788 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yale University
• Study Sponsor: Yale University

Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Steven L Bernstein, MD; Yale University

• PRS Account: Yale University
• Verification Date: August 2021