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OpenTrials
Completed

NCT Number: NCT02885532

Capacity to Consent in Acutely Intoxicated Emergency Department Patients

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.

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Key information

Conditions

Informed Consent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. The number of intoxicated emergency department patients who could correctly complete the questionnaire

    Time frame: Immediately

Secondary outcomes

  1. Alcohol concentration (breath or serum)

    Time frame: Immediately

  2. Degree of sedation

    Time frame: Immediately

    Observer's Assessment of Alertness/Sedation scale (OAA/S) score

  3. Recall of participation

    Time frame: Between 2 and 12 hours after initial enrollment, depending on the time clinical sobriety achived

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 31, 2016
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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