Outcomes of Antipsychotic Medication Used in the Emergency Department (OAMED)

July 27, 2016 updated by: Erik Kulstad, Advocate Health Care

Outcomes of Antipsychotic Medication Use in the Emergency Department: A Retrospective Comparison Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

93

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

subjects treated in the emergency department for agitation

Description

Inclusion Criteria:

  • All patients given antipsychotic therapy for acute agitation

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in the emergency department
Time Frame: 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.
Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disposition
Time Frame: 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
Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advocate Health Care

Investigators

  • Principal Investigator: Erik Kulstad, MD, Advocate Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHC6066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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