Optimizing Tobacco Dependence Treatment in the Emergency Department
Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT02896400
Collaborator
National Cancer Institute (NCI) (NIH), National Institutes of Health (NIH) (NIH)
1,056
1
16
30
35.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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:
-
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.
-
At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.
-
At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1056 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Optimizing Tobacco Dependence Treatment in the Emergency Department
Actual Study Start Date
:
Feb 13, 2017
Actual Primary Completion Date
:
Aug 14, 2019
Actual Study Completion Date
:
Aug 14, 2019
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Tobacco Abstinence [3 months]
Abstinence self reported and verified by exhaled carbon monoxide
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale School of Medicine | New Haven | Connecticut | United States | 06519 |
Sponsors and Collaborators
- Yale University
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Steven L Bernstein, MD, Yale School of Medicine, Department of Emergency Medicine
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT02896400
Other Study ID Numbers:
- 1603017332
- 1R01CA201873-01A1
First Posted:
Sep 12, 2016
Last Update Posted:
Dec 4, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | NRT+QL+Text | BNI+QL+Text | BNI+NRT+QL+Text | NRT+QL | BNI+QL | NRT Only | BNI+Text | BNI+NRT+Text | NRT+Text | BNI+NRT | Control | BNI+NRT+QL | Text Only | QL+Text | BNI Only | QL Only |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply 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. | Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) 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. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. | Control arm, no intervention | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Registration in SmokefreeText (Text) SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior | Referral to CT Smokers Quitline (QL) CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. |
| Period Title: Baseline | ||||||||||||||||
| STARTED | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 |
| COMPLETED | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Baseline | ||||||||||||||||
| STARTED | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 |
| COMPLETED | 59 | 59 | 61 | 58 | 57 | 60 | 61 | 60 | 62 | 59 | 61 | 61 | 63 | 62 | 65 | 63 |
| NOT COMPLETED | 7 | 7 | 5 | 8 | 9 | 6 | 5 | 6 | 4 | 7 | 5 | 5 | 3 | 4 | 1 | 3 |
| Period Title: Baseline | ||||||||||||||||
| STARTED | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 65 |
| COMPLETED | 60 | 63 | 60 | 55 | 54 | 60 | 62 | 63 | 60 | 61 | 60 | 60 | 63 | 60 | 62 | 63 |
| NOT COMPLETED | 6 | 3 | 6 | 11 | 12 | 6 | 4 | 3 | 6 | 5 | 6 | 6 | 3 | 6 | 4 | 2 |
| Period Title: Baseline | ||||||||||||||||
| STARTED | 60 | 63 | 60 | 55 | 54 | 60 | 62 | 63 | 60 | 61 | 60 | 60 | 63 | 60 | 62 | 63 |
| COMPLETED | 14 | 15 | 13 | 14 | 9 | 11 | 11 | 14 | 15 | 8 | 5 | 19 | 10 | 12 | 7 | 6 |
| NOT COMPLETED | 46 | 48 | 47 | 41 | 45 | 49 | 51 | 49 | 45 | 53 | 55 | 41 | 53 | 48 | 55 | 57 |
Baseline Characteristics
| Arm/Group Title | NRT+QL+Text | BNI+QL+Text | BNI+NRT+QL+Text | NRT+QL | BNI+QL | NRT Only | BNI+Text | BNI+NRT+Text | NRT+Text | BNI+NRT | Control | BNI+NRT+QL | Text Only | QL+Text | BNI Only | QL Only | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply 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. | Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) 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. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. | Control arm, no intervention | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Registration in SmokefreeText (Text) SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior | Referral to CT Smokers Quitline (QL) CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Total of all reporting groups |
| Overall Participants | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 66 | 1056 |
| Age (years) [Mean (Standard Deviation) ] | |||||||||||||||||
| Mean (Standard Deviation) [years] |
46.86
(10.72)
|
41.33
(11.92)
|
44.36
(12.75)
|
43.73
(12.14)
|
40.56
(11.97)
|
42.26
(12.27)
|
42.64
(12.42)
|
43.77
(11.80)
|
43.67
(12.60)
|
44.30
(13.23)
|
43.65
(14.00)
|
43.18
(10.67)
|
44.33
(12.23)
|
42.36
(12.49)
|
41.86
(10.42)
|
43.21
(11.77)
|
43.26
(12.12)
|
| Sex: Female, Male (Count of Participants) | |||||||||||||||||
| Female |
32
48.5%
|
38
57.6%
|
35
53%
|
28
42.4%
|
28
42.4%
|
31
47%
|
34
51.5%
|
28
42.4%
|
41
62.1%
|
35
53%
|
35
53%
|
29
43.9%
|
33
50%
|
42
63.6%
|
31
47%
|
36
54.5%
|
536
50.8%
|
| Male |
34
51.5%
|
28
42.4%
|
31
47%
|
38
57.6%
|
38
57.6%
|
35
53%
|
32
48.5%
|
38
57.6%
|
25
37.9%
|
31
47%
|
31
47%
|
37
56.1%
|
33
50%
|
24
36.4%
|
35
53%
|
30
45.5%
|
520
49.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||||||||||
| Hispanic or Latino |
14
21.2%
|
15
22.7%
|
7
10.6%
|
22
33.3%
|
15
22.7%
|
9
13.6%
|
19
28.8%
|
10
15.2%
|
14
21.2%
|
23
34.8%
|
13
19.7%
|
14
21.2%
|
13
19.7%
|
19
28.8%
|
14
21.2%
|
10
15.2%
|
231
21.9%
|
| Not Hispanic or Latino |
52
78.8%
|
51
77.3%
|
56
84.8%
|
43
65.2%
|
51
77.3%
|
55
83.3%
|
45
68.2%
|
55
83.3%
|
51
77.3%
|
43
65.2%
|
52
78.8%
|
49
74.2%
|
51
77.3%
|
45
68.2%
|
52
78.8%
|
56
84.8%
|
807
76.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
3
4.5%
|
1
1.5%
|
0
0%
|
2
3%
|
2
3%
|
1
1.5%
|
1
1.5%
|
0
0%
|
1
1.5%
|
3
4.5%
|
2
3%
|
2
3%
|
0
0%
|
0
0%
|
18
1.7%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||||||||||
| American Indian or Alaska Native |
2
3%
|
1
1.5%
|
1
1.5%
|
1
1.5%
|
2
3%
|
0
0%
|
1
1.5%
|
1
1.5%
|
1
1.5%
|
0
0%
|
1
1.5%
|
3
4.5%
|
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
15
1.4%
|
| Asian |
0
0%
|
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
0
0%
|
0
0%
|
1
1.5%
|
0
0%
|
3
0.3%
|
| Native Hawaiian or Other Pacific Islander |
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
1
1.5%
|
0
0%
|
1
1.5%
|
1
1.5%
|
2
3%
|
1
1.5%
|
0
0%
|
1
1.5%
|
0
0%
|
1
1.5%
|
0
0%
|
0
0%
|
9
0.9%
|
| Black or African American |
24
36.4%
|
25
37.9%
|
34
51.5%
|
22
33.3%
|
26
39.4%
|
24
36.4%
|
23
34.8%
|
23
34.8%
|
23
34.8%
|
19
28.8%
|
27
40.9%
|
26
39.4%
|
29
43.9%
|
28
42.4%
|
19
28.8%
|
29
43.9%
|
401
38%
|
| White |
39
59.1%
|
33
50%
|
26
39.4%
|
35
53%
|
33
50%
|
36
54.5%
|
36
54.5%
|
35
53%
|
37
56.1%
|
40
60.6%
|
29
43.9%
|
35
53%
|
30
45.5%
|
28
42.4%
|
34
51.5%
|
31
47%
|
537
50.9%
|
| More than one race |
0
0%
|
5
7.6%
|
3
4.5%
|
5
7.6%
|
2
3%
|
6
9.1%
|
4
6.1%
|
5
7.6%
|
2
3%
|
5
7.6%
|
7
10.6%
|
0
0%
|
2
3%
|
5
7.6%
|
10
15.2%
|
2
3%
|
63
6%
|
| Unknown or Not Reported |
0
0%
|
1
1.5%
|
2
3%
|
3
4.5%
|
2
3%
|
0
0%
|
1
1.5%
|
1
1.5%
|
1
1.5%
|
1
1.5%
|
2
3%
|
0
0%
|
5
7.6%
|
4
6.1%
|
2
3%
|
3
4.5%
|
28
2.7%
|
| Region of Enrollment (Count of Participants) | |||||||||||||||||
| United States |
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
66
100%
|
1056
100%
|
| Cigarettes per Day (CPD) (cigarettes per day) [Median (Inter-Quartile Range) ] | |||||||||||||||||
| Median (Inter-Quartile Range) [cigarettes per day] |
10.0
|
12.0
|
10.0
|
10.0
|
10.0
|
10.0
|
10.0
|
10.0
|
9.0
|
10.0
|
10.0
|
11.0
|
10.0
|
10.0
|
10.0
|
10.0
|
10.0
|
| Heaviness of Smoking Index >=4 (participants) [Number] | |||||||||||||||||
| Number [participants] |
15
22.7%
|
28
42.4%
|
13
19.7%
|
18
27.3%
|
9
13.6%
|
23
34.8%
|
20
30.3%
|
13
19.7%
|
13
19.7%
|
21
31.8%
|
15
22.7%
|
21
31.8%
|
19
28.8%
|
13
19.7%
|
17
25.8%
|
12
18.2%
|
270
25.6%
|
Outcome Measures
| Title | Tobacco Abstinence |
|---|---|
| Description | Abstinence self reported and verified by exhaled carbon monoxide |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants eligible for 3 month follow-up (deceased participants excluded). Each intervention group was compared with all participants who did not receive that intervention. The comparison group therefore differed for each intervention: BNI=526; NRT=525; QL=527; Text = 526. |
| Arm/Group Title | Brief Negotiated Interview (BNI) | Brief Negotiated Interview (BNI) CONTROL | Nicotine Replacement Therapy (NRT) | Nicotine Replacement Therapy (NRT) CONTROL | Quitline (QL) | Quitline (QL) CONTROL | Text | Text CONTROL |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | All 8 arms with Brief Negotiated Interview as an intervention: BNI only BNI+Nicotine Replacement Therapy (NRT) BNI+Quitline (QL) BNI+Text BNI+NRT+QL BNI+NRT+Text BNI+QL+Text BNI+NRT+QL+Text | All 8 arms which did not include the BNI intervention: NRT+QL+Text NRT+QL NRT+Text NRT QL+Text QL Text Control | All 8 arms with Nicotine Replacement Therapy as an intervention: NRT only Brief Negotiated Interview (BNI)+NRT NRT+Quitline (QL) NRT+Text BNI+NRT+QL BNI+NRT+Text NRT+QL+Text BNI+NRT+QL+Text | All 8 arms which did not include the NRT intervention: BNI+QL+Text BNI+QL BNI+Text BNI Only QL+Text QL Only Text Only Control | All 8 arms with the Quitline as an intervention: QL only Brief Negotiated Interview (BNI)+QL Nicotine Replacement Therapy (NRT)+QL QL+Text BNI+NRT+QL BNI+QL+Text NRT+QL+Text BNI+NRT+QL+Text | All 8 arms which did not include the QL intervention: BNI+NRT+Text BNI+NRT BNI+Text BNI Only NRT+Text NRT Only Text Only Control | All 8 arms with Text as an intervention: Text only Brief Negotiated Interview (BNI)+Text Nicotine Replacement Therapy (NRT)+Text Quitline (QL)+Text BNI+NRT+Text BNI+QL+Text NRT+QL+Text BNI+NRT+QL+Text | All 8 arms which did not include the Text intervention: BNI+NRT+QL BNI+NRT BNI+QL BNI Only NRT+QL NRT Only QL Only Control |
| Measure Participants | 527 | 526 | 528 | 525 | 526 | 527 | 527 | 526 |
| Count of Participants [Participants] |
71
107.6%
|
49
74.2%
|
76
115.2%
|
44
66.7%
|
66
100%
|
54
81.8%
|
61
92.4%
|
59
89.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brief Negotiated Interview (BNI), Brief Negotiated Interview (BNI) CONTROL |
|---|---|---|
| Comments | 8 arms including BNI (BNI only, BNI+NRT, BNI+QL, BNI+Text, BNI+NRT+QL, BNI+NRT+Text, BNI+QL+Text, BNI+NRT+QL+Text) compared to the 8 arms that do not include BNI (Control, NRT only, QL only, Text only, NRT+QL, NRT+Text, QL+Text, NRT+QL+Text) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .01 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | Adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.8 | |
| Confidence Interval |
(2-Sided) 95% 1.1 to 2.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Nicotine Replacement Therapy (NRT), Nicotine Replacement Therapy (NRT) CONTROL |
|---|---|---|
| Comments | 8 arms that include NRT (NRT only, BNI+NRT, NRT+QL, NRT+Text, BNI+NRT+QL, BNI+NRT+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include NRT (Control, BNI only, QL only, Text only, BNI+QL, BNI+Text, QL+Text, BNI+QL+Text) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.1 | |
| Confidence Interval |
(2-Sided) 95% 1.3 to 3.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Quitline (QL), Quitline (QL) CONTROL |
|---|---|---|
| Comments | 8 arms including QL intervention (QL only, BNI+QL, NRT+QL, QL+Text, BNI+NRT+QL, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to all 8 arms that did not include QL (Control, BNI only, NRT only, Text only, BNI+NRT, BNI+Text, NRT+Text, BNI+NRT+Text) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.4 | |
| Confidence Interval |
(2-Sided) 95% 0.9 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Text, Text CONTROL |
|---|---|---|
| Comments | 8 arms including Text (Text only, BNI+Text, NRT+Text, QL+Text, BNI+NRT+Text, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include Text (Control, BNI only, NRT only, QL only, BNI+NRT, BNI+QL, NRT+QL, BNI+NRT+QL) | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.64 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 1.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Each participant was monitored for adverse events for 3 months. | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||||||||||||||
| Arm/Group Title | NRT+QL+Text | BNI+QL+Text | BNI+NRT+QL+Text | NRT+QL | BNI+QL | NRT Only | BNI+Text | BNI+NRT+Text | NRT+Text | BNI+NRT | Control | BNI+NRT+QL | Text Only | QL+Text | BNI Only | QL Only | ||||||||||||||||
| Arm/Group Description | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply 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. | Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) 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. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. | Control arm, no intervention | Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior 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. CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | Registration in SmokefreeText (Text) SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study. | Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior | Referral to CT Smokers Quitline (QL) CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling. | ||||||||||||||||
All Cause Mortality |
||||||||||||||||||||||||||||||||
| NRT+QL+Text | BNI+QL+Text | BNI+NRT+QL+Text | NRT+QL | BNI+QL | NRT Only | BNI+Text | BNI+NRT+Text | NRT+Text | BNI+NRT | Control | BNI+NRT+QL | Text Only | QL+Text | BNI Only | QL Only | |||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 1/66 (1.5%) | 1/66 (1.5%) | 1/66 (1.5%) | ||||||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||||||||||
| NRT+QL+Text | BNI+QL+Text | BNI+NRT+QL+Text | NRT+QL | BNI+QL | NRT Only | BNI+Text | BNI+NRT+Text | NRT+Text | BNI+NRT | Control | BNI+NRT+QL | Text Only | QL+Text | BNI Only | QL Only | |||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | ||||||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||||||||||
| NRT+QL+Text | BNI+QL+Text | BNI+NRT+QL+Text | NRT+QL | BNI+QL | NRT Only | BNI+Text | BNI+NRT+Text | NRT+Text | BNI+NRT | Control | BNI+NRT+QL | Text Only | QL+Text | BNI Only | QL Only | |||||||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) | ||||||||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Steven L. Bernstein, MD |
|---|---|
| Organization | Yale School of Medicine |
| Phone | 203-737-3574 |
| steven.bernstein@yale.edu |
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT02896400
Other Study ID Numbers:
- 1603017332
- 1R01CA201873-01A1
First Posted:
Sep 12, 2016
Last Update Posted:
Dec 4, 2020
Last Verified:
Nov 1, 2020