Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers

NCT01691105 | Completed Results

• 2 other identifiers: 1205010297R18HL108788
• Study Type: interventional
• Target: 1,044
• Locations: 1 country
• Sites: 1

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).

Conditions

Tobacco Use Cessation; Smoking Cessation; Smoking; Tobacco Use Disorder

Keywords

Tobacco Use Cessation; Smoking Cessation; Nicotine Replacement Therapy; Hospitalized Smokers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence

  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.

  12 months post enrollment

Secondary Outcomes (7)

• Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months

  12 months post enrollment

• Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months

  6 months post enrollment

• Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month

  1 month post enrollment

• Number of Participants Self-Reporting Use of Cessation Medications - 1 Month

  1 month post enrollment

• Number of Participants Self-Reporting Use of Cessation Medications - 6 Months

  6 months post enrollment

Study Arms (2)

Academic Detailing (AD)

NO INTERVENTION

Standard of care for patients who are smokers and admitted to the hospital.

AD + Integrated Tobacco Order Set

EXPERIMENTAL

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

Interventions

AD + Integrated Tobacco Order Set OTHER

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

AD + Integrated Tobacco Order Set

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (2)

• 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.

  PMID: 30670043 DERIVED

• 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.

  PMID: 28194729 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation; Smoking Cessation; Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Steven Bernstein
• Organization: Yale School of Medicine

steven.bernstein@yale.edu

203-737-3574

Study Officials

• Steven L Bernstein, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 24, 2012
• Study Start: August 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 5, 2021
• Results First Posted: November 23, 2018

Record last verified: 2021-08

Locations

US (1)