Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Yale University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Steven Bernstein, Yale University
ClinicalTrials.gov Identifier:
NCT01691105
First received: September 19, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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 Intervention
Tobacco Use Cessation
Smoking Cessation
Smoking
Tobacco Use Disorder
Other: Academic Detailing + Integrated Tobacco Order Set

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Exhaled Carbon Monoxide reading [ Time Frame: 12 months post enrollment ] [ Designated as safety issue: No ]
    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:
  • Self-reported tobacco reduction or abstinence [ Time Frame: 1 month post enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 960
Study Start Date: August 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Academic Detailing
Standard of care for patients who are smokers and admitted to the hospital.
Experimental: Academic Detailing + 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: Academic Detailing + 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


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691105

Contacts
Contact: June-Marie W Rosner, MA, MEd 203-737-3582 junemarie.rosner@yale.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Steven L Bernstein, MD    203-737-3574    steven.bernstein@yale.edu   
Contact: June-Marie W Rosner, MA, MEd    203-737-3582    junemarie.rosner@yale.edu   
Sub-Investigator: Benjamin Toll, PhD         
Sub-Investigator: Gail D'Onofrio, MD, MS         
Sub-Investigator: James Dziura, PhD         
Sub-Investigator: Stephanie O'Malley, PhD         
Sub-Investigator: Allen Hsiao, MD         
Sub-Investigator: Patrick O'Connor, MD         
Sub-Investigator: Jeanette Tetrault, MD         
Principal Investigator: Steven L Bernstein, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Steven L Bernstein, MD Yale University
  More Information

No publications provided

Responsible Party: Steven Bernstein, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01691105     History of Changes
Other Study ID Numbers: 1205010297, R18HL108788
Study First Received: September 19, 2012
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Yale University:
Tobacco Use Cessation
Smoking Cessation
Nicotine Replacement Therapy
Hospitalized Smokers

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014