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
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