Harmful DrinkingPhase 2/3NCT00261859
Enhancing Emergency Practitioner (EP)-Performed Alcohol Interventions in the Emergency Department (ED)
A Phase 2/3 study testing BNI in people with Harmful Drinking, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of an enhanced emergency practitioner (EP) performed brief intervention (BI), namely, the Enhanced Brief Negotiation Interview (E-BNI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Harmful Drinking
- What is being tested?
- BNI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Nov 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, 18 years or older, who present to the adult ED at Yale-New Haven Hospital will be screened for exceeding the NIAAA criteria for low-risk drinking
- Patients may be hazardous "at-risk" drinkers who screen over the limits, but do not currently exhibit medical, social or legal problems as a result of their drinking, or they may be harmful drinkers, presenting with an alcohol associated injury or illness.
Who cannot join
- Patients will be excluded for the following reasons:
- Non-English speaking;
- Alcohol dependence;
- Current enrollment in a substance abuse treatment program;
- Current ED visit for acute psychiatric complaint;
- Condition that precludes interview i.e., life threatening injury/illness;
- In police custody; or
- Inability to provide two contact numbers for follow-up.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital (Adult Emergency Department)
New Haven, Connecticut, 06510
About this study
Official title: Enhancing EP-Performed Alcohol Interventions in the ED
The purpose of this study is to evaluate the effectiveness of an enhanced emergency practitioner (EP) performed brief intervention (BI), namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 hazardous and harmful (HH) drinkers will be randomly assigned to one of the 4 conditions. We, the researchers at Yale University, will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).
Read the detailed description
A critical need exists to refine and test brief interventions (BI) for Emergency Department (ED) populations with hazardous and harmful (HH) drinking that can be translated into real-world settings; and to enhance the effects of these BIs so they can be maintained over time. The ED is an ideal setting for BIs, as many ED patients who exceed low-risk recommendations do not have contact with either alcohol treatment specialists or visit primary care medical practitioners. This includes a large segment of young adults ages 18-30 whose only contact with the health care system is often an ED visit. The purpose of this study is to evaluate the effectiveness of an enhanced Emergency Practitioner (EP) performed BI, namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 HH drinkers will be randomly assigned to one of the 4 conditions. We will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).
- Conditions
- Harmful Drinking
- Being tested
- BNI
- Keywords
- hazardous drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNIBehavioural
behavioral- brief intervention
| Study group | Role | What they receive |
|---|---|---|
| SCA | No intervention | Standard Care with Assessment |
| SCNA | No intervention | Standard Care No Assessment |
| BNI | Experimental | Brief Negotiated Interview Receives: Behavioral: BNI |
| EBNI | Experimental | Enhanced Brief Negotiated Interview Receives: Behavioral: BNI |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of brief intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Harmful DrinkingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Gail D'Onofrio, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261859
- Sponsor's protocol ID
- 0303025116
- Other IDs
- R01AA014963-01A1
- Status last verified
- Mar 2020
- First submitted
- 2 Dec 2005
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
D'Onofrio G, Fiellin DA, Pantalon MV, Chawarski MC, Owens PH, Degutis LC, Busch SH, Bernstein SL, O'Connor PG. A brief intervention reduces hazardous and harmful drinking in emergency department patients. Ann Emerg Med. 2012 Aug;60(2):181-92. doi: 10.1016/j.annemergmed.2012.02.006. Epub 2012 Mar 28.
PubMed 22459448
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing EP-Performed Alcohol Interventions in the ED
- ClinicalTrials.gov ID
- NCT00261859
- Acronym / sponsor ID
- 0303025116
- Conditions
- Harmful Drinking
- Keywords
- hazardous drinking
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of an enhanced emergency practitioner (EP) performed brief intervention (BI), namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 hazardous and harmful (HH) drinkers will be randomly assigned to one of the 4 conditions. We, the researchers at Yale University, will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).
Detailed description
A critical need exists to refine and test brief interventions (BI) for Emergency Department (ED) populations with hazardous and harmful (HH) drinking that can be translated into real-world settings; and to enhance the effects of these BIs so they can be maintained over time. The ED is an ideal setting for BIs, as many ED patients who exceed low-risk recommendations do not have contact with either alcohol treatment specialists or visit primary care medical practitioners. This includes a large segment of young adults ages 18-30 whose only contact with the health care system is often an ED visit. The purpose of this study is to evaluate the effectiveness of an enhanced Emergency Practitioner (EP) performed BI, namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 HH drinkers will be randomly assigned to one of the 4 conditions. We will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCA | No intervention | –Standard Care with Assessment |
| SCNA | No intervention | –Standard Care No Assessment |
| BNI | Experimental | Behavioral: BNIBrief Negotiated Interview |
| EBNI | Experimental | Behavioral: BNIEnhanced Brief Negotiated Interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients, 18 years or older, who present to the adult ED at Yale-New Haven Hospital will be screened for exceeding the NIAAA criteria for low-risk drinking
- Patients may be hazardous "at-risk" drinkers who screen over the limits, but do not currently exhibit medical, social or legal problems as a result of their drinking, or they may be harmful drinkers, presenting with an alcohol associated injury or illness.
Key exclusion criteria (8 listed)
- Non-English speaking;
- Alcohol dependence;
- Current enrollment in a substance abuse treatment program;
- Current ED visit for acute psychiatric complaint;
- Condition that precludes interview i.e., life threatening injury/illness;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNIbehavioral- brief intervention | Behavioural | BNI, EBNI |
Primary outcome
efficacy of brief intervention
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Background: PubMed 22459448D'Onofrio G, Fiellin DA, Pantalon MV, Chawarski MC, Owens PH, Degutis LC, Busch SH, Bernstein SL, O'Connor PG. A brief intervention reduces hazardous and harmful drinking in emergency department patients. Ann Emerg Med. 2012 Aug;60(2):181-92. doi: 10.1016/j.annemergmed.2012.02.006. Epub 2012 Mar 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail D'Onofrio, MD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BNI in people with Harmful Drinking, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of brief intervention (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00261859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.