Alcohol IntoxicationNCT01783223
Prevalence of Chronic Inebriates to the Emergency Department and Suitability for Sobering House Services
An observational study of Alcohol Intoxication, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
This study is intended to evaluate the prevalence of chronically inebriated patients in the Emergeny Department (ED). Patients will be identified prospectively by screening all patients (24/7) presenting to the ED for one month. A running tally of all patients in the ED will be kept. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Intoxication
- How many people
- 668 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 14 Oct 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patients in the emergency department for alcohol intoxication
Who may be able to join
- Patients in the emergency department for alcohol intoxication
Who cannot join
- Under 18
- Prisoners
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
This study is intended to evaluate the prevalence of chronically inebriated patients in the Emergeny Department (ED). Patients will be identified prospectively by screening all patients (24/7) presenting to the ED for one month. A running tally of all patients in the ED will be kept. Of these patients, any patient that is noted to have alcohol intoxication will be identified. The chart of that patient will be reviewed for details about the patient's alcohol use and for the patient's suitability for a sobering house, which is a place where intoxicated patients can go to await sobriety. The chart will also be reviewed for the number of previous visits for alcohol use to our hospital ever and in the last year.
Read the detailed description
For this cross-sectional study, all patients presenting to the ED of an urban, Level 1 trauma center for one month were prospectively screened by trained research associates. When an intoxicated patient was identified, study information including patient demographics, diagnoses, vital signs, blood alcohol concentration (BAC), GCS on arrival, ability to ambulate independently on arrival, use of physical or chemical restraint, previous ED visits, length of stay, and health insurance was collected. Data was analyzed using descriptive statistics.
- Conditions
- Alcohol Intoxication
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intoxicated patients | patients in the Emergency Department who appear to be intoxicated with ethanol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intoxicated Patients Eligible for a Sobering House
Determine the proportion of patients in the emergency department that are intoxicated and how many of those would be eligible to go to a sobering house. Eligibility for a sobering house is at the discretion of the treating physician and includes the ability to ambulate without assistance and no further acute need for medical treatments.
Measured: Eligibility for a sobering house is assessed during the current ED admission. The study ends when patient is discharged from the ED, an expected average time of 9 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startNov 2012
- Primary completion26 Jun 2018
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol IntoxicationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Miner, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783223
- Sponsor's protocol ID
- 12-3560
- Status last verified
- Aug 2022
- First submitted
- 23 Jan 2013
- Last updated
- 15 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Inebriates to the Emergency Department and Suitability for Sobering House Services
- ClinicalTrials.gov ID
- NCT01783223
- Acronym / sponsor ID
- 12-3560
- Conditions
- Alcohol Intoxication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Posted 15 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to evaluate the prevalence of chronically inebriated patients in the Emergeny Department (ED). Patients will be identified prospectively by screening all patients (24/7) presenting to the ED for one month. A running tally of all patients in the ED will be kept. Of these patients, any patient that is noted to have alcohol intoxication will be identified. The chart of that patient will be reviewed for details about the patient's alcohol use and for the patient's suitability for a sobering house, which is a place where intoxicated patients can go to await sobriety. The chart will also be reviewed for the number of previous visits for alcohol use to our hospital ever and in the last year.
Detailed description
For this cross-sectional study, all patients presenting to the ED of an urban, Level 1 trauma center for one month were prospectively screened by trained research associates. When an intoxicated patient was identified, study information including patient demographics, diagnoses, vital signs, blood alcohol concentration (BAC), GCS on arrival, ability to ambulate independently on arrival, use of physical or chemical restraint, previous ED visits, length of stay, and health insurance was collected. Data was analyzed using descriptive statistics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intoxicated patients | – | –patients in the Emergency Department who appear to be intoxicated with ethanol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the emergency department for alcohol intoxication
Key inclusion criteria (1 listed)
- Patients in the emergency department for alcohol intoxication
Key exclusion criteria (3 listed)
- Under 18
- Prisoners
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intoxicated Patients Eligible for a Sobering House
Time frame: Eligibility for a sobering house is assessed during the current ED admission. The study ends when patient is discharged from the ED, an expected average time of 9 hours.
Determine the proportion of patients in the emergency department that are intoxicated and how many of those would be eligible to go to a sobering house. Eligibility for a sobering house is at the discretion of the treating physician and includes the ability to ambulate without assistance and no further acute need for medical treatments.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James Miner, MD principal investigator
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Intoxication, run by Hennepin Healthcare Research Institute 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 1 inclusion and 3 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 15 Sep 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intoxicated Patients Eligible for a Sobering House (time frame: Eligibility for a sobering house is assessed during the current ED admission. The study ends when patient is discharged from the ED, an expected average time of 9 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2022.