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Optimizing Tobacco Dependence Treatment in the Emergency Department

NCT ID: NCT02896400

Last Updated: 2020-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1056 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2019-08-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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)

Group Type EXPERIMENTAL

Brief Negotiated Interview (BNI)

Intervention Type BEHAVIORAL

Brief motivational interview on smoking behavior

Nicotine replacement therapy (NRT)

Intervention Type DRUG

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.

CT Smokers Quitline (QL)

Intervention Type OTHER

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

SmokefreeText (Text)

Intervention Type OTHER

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

BNI+NRT+QL

Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)

Group Type EXPERIMENTAL

Brief Negotiated Interview (BNI)

Intervention Type BEHAVIORAL

Brief motivational interview on smoking behavior

Nicotine replacement therapy (NRT)

Intervention Type DRUG

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.

CT Smokers Quitline (QL)

Intervention Type OTHER

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

BNI+NRT+Text

Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)

Group Type EXPERIMENTAL

Brief Negotiated Interview (BNI)

Intervention Type BEHAVIORAL

Brief motivational interview on smoking behavior

Nicotine replacement therapy (NRT)

Intervention Type DRUG

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.

SmokefreeText (Text)

Intervention Type OTHER

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

BNI+NRT

Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply

Group Type EXPERIMENTAL

Brief Negotiated Interview (BNI)

Intervention Type BEHAVIORAL

Brief motivational interview on smoking behavior

Nicotine replacement therapy (NRT)

Intervention Type DRUG

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.

BNI+QL+Text

Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)

Group Type EXPERIMENTAL

Brief Negotiated Interview (BNI)

Intervention Type BEHAVIORAL

Brief motivational interview on smoking behavior

CT Smokers Quitline (QL)

Intervention Type OTHER

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

SmokefreeText (Text)

Intervention Type OTHER

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

BNI+QL

Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)

Group Type EXPERIMENTAL

Brief Negotiated Interview (BNI)

Intervention Type BEHAVIORAL

Brief motivational interview on smoking behavior

CT Smokers Quitline (QL)

Intervention Type OTHER

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

BNI+Text

Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)

Group Type EXPERIMENTAL

Brief Negotiated Interview (BNI)

Intervention Type BEHAVIORAL

Brief motivational interview on smoking behavior

SmokefreeText (Text)

Intervention Type OTHER

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

BNI only

Brief Negotiated Interview (BNI)

Group Type EXPERIMENTAL

Brief Negotiated Interview (BNI)

Intervention Type BEHAVIORAL

Brief motivational interview on smoking behavior

NRT+QL+Text

Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)

Group Type EXPERIMENTAL

Nicotine replacement therapy (NRT)

Intervention Type DRUG

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.

CT Smokers Quitline (QL)

Intervention Type OTHER

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

SmokefreeText (Text)

Intervention Type OTHER

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

NRT+QL

Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)

Group Type EXPERIMENTAL

Nicotine replacement therapy (NRT)

Intervention Type DRUG

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.

CT Smokers Quitline (QL)

Intervention Type OTHER

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

NRT+Text

Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)

Group Type EXPERIMENTAL

Nicotine replacement therapy (NRT)

Intervention Type DRUG

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.

SmokefreeText (Text)

Intervention Type OTHER

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

NRT only

Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply

Group Type EXPERIMENTAL

Nicotine replacement therapy (NRT)

Intervention Type DRUG

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.

QL+Text

Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)

Group Type EXPERIMENTAL

CT Smokers Quitline (QL)

Intervention Type OTHER

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

SmokefreeText (Text)

Intervention Type OTHER

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

QL only

Referral to CT Smokers Quitline (QL)

Group Type EXPERIMENTAL

CT Smokers Quitline (QL)

Intervention Type OTHER

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Text only

Registration in SmokefreeText (Text)

Group Type EXPERIMENTAL

SmokefreeText (Text)

Intervention Type OTHER

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Control

Control arm, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brief Negotiated Interview (BNI)

Brief motivational interview on smoking behavior

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

CT Smokers Quitline (QL)

Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.

Intervention Type OTHER

SmokefreeText (Text)

Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven L Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

Yale School of Medicine, Department of Emergency Medicine

Locations

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Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29287665 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01CA201873-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1603017332

Identifier Type: -

Identifier Source: org_study_id