Informed ConsentNCT02885532
Capacity to Consent in Acutely Intoxicated Emergency Department Patients
An observational study of Informed Consent, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
The ability to meaningfully consent intoxicated and chemically dependent patients for research has inhibited medical advances in this vulnerable population. A recent pilot supported use of the University of California, San Diego Brief Assessment of Capacity to Consent tool to assess the capacity of intoxicated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Informed Consent
- What is being tested?
- University of California, San Diego Brief Assessment of Capacity to Consent Tool
- How many people
- 417 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Mar 2016
- Phase
- Observational
- 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
Study population: Non-pregnant, English speaking patients aged 18 years or older with clinical evidence of acute alcohol intoxication as the predominant etiology of mental status changes were eligible.
Who may be able to join
- 18 years or older, intoxicated with alcohol
Who cannot join
- intoxication was due to a substance other than ethanol (negative breath alcohol concentration), refusal to participate, excessive agitation, or if the treating physician deemed the patient medically or psychologically unstable. Patients were also excluded if they had previously been enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: The University of California, San Diego Brief Assessment of Capacity to Consent Instrument in Acutely Intoxicated Emergency Department Patients
The ability to meaningfully consent intoxicated and chemically dependent patients for research has inhibited medical advances in this vulnerable population. A recent pilot supported use of the University of California, San Diego Brief Assessment of Capacity to Consent tool to assess the capacity of intoxicated emergency department patients to participate in research. The objective is to determine the number of intoxicated emergency department patients who could correctly complete the questionnaire, and evaluate alcohol concentration, sedation and ability to recall participation upon sobriety.
- Conditions
- Informed Consent
- Being tested
- University of California, San Diego Brief Assessment of Capacity to Consent Tool
- Keywords
- alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
University of California, San Diego Brief Assessment of Capacity to Consent ToolOther
Non-pregnant, English speaking patients older than 18 with evidence of acute alcohol intoxication were considered eligible for participation. Patients were asked to complete the 10 question tool on arrival to the emergency department. Patie
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of intoxicated emergency department patients who could correctly complete the questionnaire
Measured: Immediately
Secondary outcomes (3)
Alcohol concentration (breath or serum)
Measured: Immediately
Degree of sedation
Observer's Assessment of Alertness/Sedation scale (OAA/S) score
Measured: Immediately
Recall of participation
Measured: Between 2 and 12 hours after initial enrollment, depending on the time clinical sobriety achived
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionMar 2016
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 Informed ConsentStudies 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
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885532
- Sponsor's protocol ID
- 15-3949
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McCormack RP, Gallagher T, Goldfrank LR, Caplan AL. Including frequent emergency department users with severe alcohol use disorders in research: assessing capacity. Ann Emerg Med. 2015 Feb;65(2):172-7.e1. doi: 10.1016/j.annemergmed.2014.09.027. Epub 2014 Oct 23.
PubMed 25447556
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The University of California, San Diego Brief Assessment of Capacity to Consent Instrument in Acutely Intoxicated Emergency Department Patients
- ClinicalTrials.gov ID
- NCT02885532
- Acronym / sponsor ID
- 15-3949
- Conditions
- Informed Consent
- Keywords
- alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 31 Aug 2016 (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 ability to meaningfully consent intoxicated and chemically dependent patients for research has inhibited medical advances in this vulnerable population. A recent pilot supported use of the University of California, San Diego Brief Assessment of Capacity to Consent tool to assess the capacity of intoxicated emergency department patients to participate in research. The objective is to determine the number of intoxicated emergency department patients who could correctly complete the questionnaire, and evaluate alcohol concentration, sedation and ability to recall participation upon sobriety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-pregnant, English speaking patients aged 18 years or older with clinical evidence of acute alcohol intoxication as the predominant etiology of mental status changes were eligible.
Key inclusion criteria (1 listed)
- 18 years or older, intoxicated with alcohol
Key exclusion criteria (1 listed)
- intoxication was due to a substance other than ethanol (negative breath alcohol concentration), refusal to participate, excessive agitation, or if the treating physician deemed the patient medically or psychologically unstable. Patients were also excluded if they had previously been enrolled in the study
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 |
|---|---|---|
| University of California, San Diego Brief Assessment of Capacity to Consent ToolNon-pregnant, English speaking patients older than 18 with evidence of acute alcohol intoxication were considered eligible for participation. Patients were asked to complete the 10 question tool on arrival to the emergency department. Patie | Other | – |
Primary outcome
The number of intoxicated emergency department patients who could correctly complete the questionnaire
Time frame: Immediately
3 secondary outcomes
Alcohol concentration (breath or serum)
Time frame: Immediately
Degree of sedation
Time frame: Immediately
Recall of participation
Time frame: Between 2 and 12 hours after initial enrollment, depending on the time clinical sobriety achived
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 31 Aug 2016.
- Results publication: PubMed 25447556McCormack RP, Gallagher T, Goldfrank LR, Caplan AL. Including frequent emergency department users with severe alcohol use disorders in research: assessing capacity. Ann Emerg Med. 2015 Feb;65(2):172-7.e1. doi: 10.1016/j.annemergmed.2014.09.027. Epub 2014 Oct 23.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Informed Consent, 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 1 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 31 Aug 2016. 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?
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?
The number of intoxicated emergency department patients who could correctly complete the questionnaire (time frame: Immediately). 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 NCT02885532, 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 31 Aug 2016.