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Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

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ClinicalTrials.gov Identifier: NCT01691105
Recruitment Status : Completed
First Posted : September 24, 2012
Results First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University

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).


Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Smoking Cessation Smoking Tobacco Use Disorder Other: AD + Integrated Tobacco Order Set Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1044 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers
Study Start Date : August 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
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
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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 1, 6, and 12 months post enrollment.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691105


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Steven L Bernstein, MD Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01691105     History of Changes
Other Study ID Numbers: 1205010297
R18HL108788 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2012    Key Record Dates
Results First Posted: November 22, 2018
Last Update Posted: November 22, 2018
Last Verified: October 2018
Keywords provided by Yale University:
Tobacco Use Cessation
Smoking Cessation
Nicotine Replacement Therapy
Hospitalized Smokers
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs