Capacity to Consent in Acutely Intoxicated Emergency Department Patients

NCT02885532 | Completed DMC

• 1 other identifier: 15-3949
• Study Type: observational
• Target: 417
• Locations: 1 country
• Sites: 1

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.

Conditions

Informed Consent

Keywords

alcohol

Outcome Measures

Primary Outcomes (1)

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

  Immediately

Secondary Outcomes (3)

• Alcohol concentration (breath or serum)

  Immediately

• Degree of sedation

  Immediately

• Recall of participation

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-pregnant, English speaking patients aged 18 years or older with clinical evidence of acute alcohol intoxication as the predominant etiology of mental status changes were eligible.

You may qualify if:

• 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

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related 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 Oct 23.

  PMID: 25447556 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 31, 2016
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)