Capacity to Consent in Acutely Intoxicated Emergency Department Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

417 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Informed Consent

Keywords

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alcohol

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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 Oct 23.

Reference Type RESULT

PMID: 25447556 (View on PubMed)

Other Identifiers

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15-3949

Identifier Type: -

Identifier Source: org_study_id