N/A
N=1,044
Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers
Tobacco Use Cessation · Smoking Cessation · Smoking · Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01691105 ↗Enrolled (actual)
1,044
Serious AEs
—
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence — 53; 65 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AD + Integrated Tobacco Order Set (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence |
53; 65 | — |
| SECONDARY Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months |
78; 86 | — |
| SECONDARY Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months |
68; 83 | — |
| SECONDARY Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month |
72; 87 | — |
| SECONDARY Number of Participants Self-Reporting Use of Cessation Medications - 1 Month |
126; 187 | — |
| SECONDARY Number of Participants Self-Reporting Use of Cessation Medications - 6 Months |
100; 146 | — |
| SECONDARY Number of Participants Self-Reporting Use of Cessation Medications - 12 Months |
100; 136 | — |
| SECONDARY Number of Participants Self-Reporting Treatment Engagement - 1 Month |
32; 80 | — |
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).
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)
Data sourced from ClinicalTrials.gov (NCT01691105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.