OAMED: Outcomes of Antipsychotic Medication Used in the Emergency Department

• Sponsor: Advocate Health Care (Other)
• Overall Status: Completed
• CT.gov ID: NCT02504450
• Collaborator: (none)
• Enrollment: 93
• Duration (Months): 11

Study Details

Study Description

Brief Summary

To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol) in order to evaluate outcomes.

Condition or Disease	Intervention/Treatment	Phase
Agitation,Psychomotor	Drug: Adasuve; Drug: Alternative medications

Detailed Description

A retrospective chart review will be performed for all patients presenting to the ED with agitation and subsequently given antipsychotic therapy for treatment. Identification of patients will be through chart review of patients presenting with agitation. Data to be recorded include patient age, gender, medical history, time of presentation, time of treatment, co morbidities, use of restraint, time to disposition and patient outcome. Inclusion criteria include all patients over age 18 presenting to the ED with agitation and treated with antipsychotics. No patients will be knowingly excluded from analysis. We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.

Study Design

• Study Type: Observational
• Actual Enrollment: 93 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Outcomes of Antipsychotic Medication Use in the Emergency Department: A Retrospective Comparison Study
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Outcome Measures

Primary Outcome Measures

1. Length of stay in the emergency department [Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.]

   We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.

Secondary Outcome Measures

1. Disposition [Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.]

   disposition (home, transfer, admit), and time to disposition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients given antipsychotic therapy for acute agitation

Exclusion Criteria:

• None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Advocate Health Care

Investigators

• Principal Investigator: Erik Kulstad, MD, Advocate Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erik Kulstad, Principal Investigator, Advocate Health Care
• ClinicalTrials.gov Identifier: NCT02504450
• Other Study ID Numbers: AHC6066
• First Posted: Jul 22, 2015
• Last Update Posted: Jul 28, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Erik Kulstad, Principal Investigator, Advocate Health Care: Bipolar 1 disorder; schizophrenia
• Additional relevant MeSH terms: Psychomotor Agitation; Emergencies; Haloperidol; Ziprasidone; Loxapine

Study Results

No Results Posted as of Jul 28, 2016