Capacity to Consent in Acutely Intoxicated Emergency Department Patients

Informed Consent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885532
• Other study ID #: 15-3949
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: August 26, 2016
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emergencies
• Informed Consent

Intervention

Other:
• University 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

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of intoxicated emergency department patients who could correctly complete the questionnaire		Immediately	No
Secondary	Alcohol concentration (breath or serum)		Immediately	No
Secondary	Degree of sedation	Observer's Assessment of Alertness/Sedation scale (OAA/S) score	Immediately	No
Secondary	Recall of participation		Between 2 and 12 hours after initial enrollment, depending on the time clinical sobriety achived	No