Capacity to Consent in Acutely Intoxicated Emergency Department Patients

Completed

Conditions studied: Informed Consent

In brief

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.

Key facts

Study ID

NCT02885532

Run by

Hennepin Healthcare Research Institute

People needed

417

Starts

2015-07-01

Expected to finish

2016-03-01

Last updated by the study team

2016-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older, intoxicated with alcohol

You may not qualify if…

• 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

Where it is running

• Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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