N/A Completed N=1,044 Randomized Single-blind Treatment

Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

Tobacco Use Cessation · Smoking Cessation · Smoking · Tobacco Use

Source: ClinicalTrials.gov NCT01691105 ↗

Enrolled (actual)

1,044

Serious AEs

—

Results posted

Nov 2018

Primary outcomePrimary: Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence — 53; 65 participants

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).

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	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.