Optimizing Tobacco Dependence Treatment in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Behavioral: Brief Negotiated Interview (BNI); Drug: Nicotine replacement therapy (NRT); Other: CT Smokers Quitline (QL); Other: SmokefreeText (Text)

Detailed Description

The investigators propose to optimize the identification and treatment of adult smokers seen in a hospital ED. To do this the Multiple Optimization Strategy (MOST) will be employed to develop a multicomponent intervention that will consist of some combination of the following: (1) a Brief Negotiation Interview (BNI, a variant of a motivational interview), delivered by a trained research assistant; (2) provision of 6 weeks of nicotine patches and gum to the research participant, with application of the first patch in the ED (NRT); (3) active referral to the Connecticut Smokers' Quitline (QL); and (4) enrollment in the SmokefreeText a short-messaging service (SMS) texting program for mobile phones (Text). Using MOST principles, the first phase of the study will use a 2x2x2x2 full-factorial design to identify the components most likely to be efficacious in combination. Although the factorial design requires the allocation of participants to 16 different combinations of the 4 components (Table 1), evaluation of each individual component is performed comparing all of those receiving a component to all of those not receiving a component, making this an efficient design. For instance, evaluation of the BNI component will compare those randomized to arms 1 through 8 to those in arms 9 to 16.The second phase will consist of designing and proposing a 2-arm randomized clinical trial comparing the efficacy of the multicomponent intervention package to usual care; this will be conducted in a future application.

The specific aims of this proposed study are:

Aim 1. To conduct a fully powered factorial randomized trial of 1056 adult smokers to test the efficacy of 4 key components of ED-initiated tobacco treatment: Brief Negotiated Interview (BNI), nicotine replacement therapy (NRT), Quitline referral (QL), and SmokeFreeText (Text).

Aim 2. To identify the most efficacious components of our intervention, within fixed constraints of cost effectiveness and feasibility/acceptability to providers and subjects.

Aim 3. To lay the groundwork for a future randomized trial testing the previously identified components, delivered as a package, against a control arm in a new cohort of adult ED smokers.

Our associated hypotheses are:

1. At 3 months, at least 1 intervention component will yield a biochemically verified tobacco abstinence rate at least 5% greater than in the control condition. Carbon monoxide breath test will be used for biochemical verification.
2. At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.
3. At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.

• Study Type: Interventional
• Enrollment (Actual): 1056
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BNI+NRT+QL+Text; Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)	Behavioral: Brief Negotiated Interview (BNI); Brief motivational interview on smoking behavior; Drug: Nicotine replacement therapy (NRT); 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.; Other: CT Smokers Quitline (QL); Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.; Other: SmokefreeText (Text); Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Experimental: BNI+NRT+QL; Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)	Behavioral: Brief Negotiated Interview (BNI); Brief motivational interview on smoking behavior; Drug: Nicotine replacement therapy (NRT); 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.; Other: CT Smokers Quitline (QL); Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
Experimental: BNI+NRT+Text; Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)	Behavioral: Brief Negotiated Interview (BNI); Brief motivational interview on smoking behavior; Drug: Nicotine replacement therapy (NRT); 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.; Other: SmokefreeText (Text); Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Experimental: BNI+NRT; Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply	Behavioral: Brief Negotiated Interview (BNI); Brief motivational interview on smoking behavior; Drug: Nicotine replacement therapy (NRT); 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.
Experimental: BNI+QL+Text; Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)	Behavioral: Brief Negotiated Interview (BNI); Brief motivational interview on smoking behavior; Other: CT Smokers Quitline (QL); Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.; Other: SmokefreeText (Text); Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Experimental: BNI+QL; Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)	Behavioral: Brief Negotiated Interview (BNI); Brief motivational interview on smoking behavior; Other: CT Smokers Quitline (QL); Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
Experimental: BNI+Text; Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)	Behavioral: Brief Negotiated Interview (BNI); Brief motivational interview on smoking behavior; Other: SmokefreeText (Text); Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Experimental: BNI only; Brief Negotiated Interview (BNI)	Behavioral: Brief Negotiated Interview (BNI); Brief motivational interview on smoking behavior
Experimental: NRT+QL+Text; Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)	Drug: Nicotine replacement therapy (NRT); 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.; Other: CT Smokers Quitline (QL); Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.; Other: SmokefreeText (Text); Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Experimental: NRT+QL; Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)	Drug: Nicotine replacement therapy (NRT); 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.; Other: CT Smokers Quitline (QL); Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
Experimental: NRT+Text; Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)	Drug: Nicotine replacement therapy (NRT); 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.; Other: SmokefreeText (Text); Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Experimental: NRT only; Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply	Drug: Nicotine replacement therapy (NRT); 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.
Experimental: QL+Text; Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)	Other: CT Smokers Quitline (QL); Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.; Other: SmokefreeText (Text); Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
Experimental: QL only; Referral to CT Smokers Quitline (QL)	Other: CT Smokers Quitline (QL); Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
Experimental: Text only; Registration in SmokefreeText (Text)	Other: SmokefreeText (Text); Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
No Intervention: Control; Control arm, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Abstinence	Abstinence self reported and verified by exhaled carbon monoxide	3 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Steven L Bernstein, MD, Yale School of Medicine, Department of Emergency Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): August 14, 2019
• Study Completion (Actual): August 14, 2019

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease Attributes; Emergencies; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 1603017332; 1R01CA201873-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No