Capacity to Consent in Acutely Intoxicated Emergency Department Patients

The University of California, San Diego Brief Assessment of Capacity to Consent Instrument in Acutely Intoxicated Emergency Department Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02885532

Enrollment

417

Registered

2016-08-31

Start date

2015-07-31

Completion date

2016-03-31

Last updated

2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Informed Consent

Keywords

alcohol

Brief 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 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.

Interventions

OTHERUniversity of California, San Diego Brief Assessment of Capacity to Consent Tool

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years or older, intoxicated with alcohol

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
The number of intoxicated emergency department patients who could correctly complete the questionnaire	Immediately

Secondary

Measure	Time frame	Description
Alcohol concentration (breath or serum)	Immediately	—
Degree of sedation	Immediately	Observer's Assessment of Alertness/Sedation scale (OAA/S) score
Recall of participation	Between 2 and 12 hours after initial enrollment, depending on the time clinical sobriety achived	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026