Capacity to Consent in Acutely Intoxicated Emergency Department Patients

Completed

• Conditions: Informed Consent

• Registration Number: NCT02885532
• Lead Sponsor: Hennepin Healthcare Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2015-09
• Study Completion: 2016-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-26
• Last Update Submitted: 2016-08-26
• Study First Posted: 2016-08-31
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 417

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of intoxicated emergency department patients who could correctly complete the questionnaire	Immediately

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States