Optimizing Tobacco Dependence Treatment in the Emergency Department
2 other identifiers
interventional
1,056
1 country
1
Brief Summary
The investigators propose an innovative full-factorial design in a cohort of 1056 adult smokers in an urban emergency department (ED), to test the efficacy of four key intervention components: motivational interviewing, medication, quitline referral, and texting. At the trial's completion, a mixed-methods approach will be used to identify the components that were efficacious within the proposed cost constraint, along with feasibility and acceptability to providers and subjects. The investigators will then assemble an intervention that maximizes efficacy, given a cost-effectiveness constraint and findings from a qualitative analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedStudy Start
First participant enrolled
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2019
CompletedResults Posted
Study results publicly available
November 16, 2020
CompletedDecember 4, 2020
November 1, 2020
2.5 years
September 6, 2016
August 21, 2020
November 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Tobacco Abstinence
Abstinence self reported and verified by exhaled carbon monoxide
3 months
Study Arms (16)
BNI+NRT+QL+Text
EXPERIMENTALBrief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
BNI+NRT+QL
EXPERIMENTALBrief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
BNI+NRT+Text
EXPERIMENTALBrief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
BNI+NRT
EXPERIMENTALBrief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
BNI+QL+Text
EXPERIMENTALBrief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
BNI+QL
EXPERIMENTALBrief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
BNI+Text
EXPERIMENTALBrief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
BNI only
EXPERIMENTALBrief Negotiated Interview (BNI)
NRT+QL+Text
EXPERIMENTALNicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
NRT+QL
EXPERIMENTALNicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
NRT+Text
EXPERIMENTALNicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
NRT only
EXPERIMENTALNicotine replacement therapy (NRT) patches and gum, 6 weeks supply
QL+Text
EXPERIMENTALReferral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
QL only
EXPERIMENTALReferral to CT Smokers Quitline (QL)
Text only
EXPERIMENTALRegistration in SmokefreeText (Text)
Control
NO INTERVENTIONControl arm, no intervention
Interventions
Brief motivational interview on smoking behavior
6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Eligibility Criteria
You may qualify if:
- years or older
- have smoked \>= 100 cigarettes lifetime
- describe themselves as every or some day smokers
- smoke at least 5 cigarettes/day
- own a cellphone with texting capability
- are able to give written informed consent
You may not qualify if:
- Inability to read or understand English
- currently receiving formal tobacco dependence treatment
- life-threatening or unstable medical, surgical, or psychobehavioral condition
- unable to provide at least one collateral contact
- live out-of-state
- leaving the ED against medical advice
- pregnant (self-report or urine testing), nursing, or trying to conceive.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Cancer Institute (NCI)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Yale School of Medicine
New Haven, Connecticut, 06519, United States
Related Publications (1)
Bernstein SL, Dziura J, Weiss J, Miller T, Vickerman KA, Grau LE, Pantalon MV, Abroms L, Collins LM, Toll B. Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy. Contemp Clin Trials. 2018 Mar;66:1-8. doi: 10.1016/j.cct.2017.12.016. Epub 2017 Dec 27.
PMID: 29287665DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steven L. Bernstein, MD
- Organization
- Yale School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Steven L Bernstein, MD
Yale School of Medicine, Department of Emergency Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2016
First Posted
September 12, 2016
Study Start
February 13, 2017
Primary Completion
August 14, 2019
Study Completion
August 14, 2019
Last Updated
December 4, 2020
Results First Posted
November 16, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share