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

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ClinicalTrials.gov Identifier: NCT02504450
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Erik Kulstad, Advocate Health Care

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

Condition or disease Intervention/treatment
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
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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 : April 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Intervention Details:
  • Drug: Adasuve
    Inhaled medication to treat acute agitation in the emergency department
    Other Name: Loxapine
  • Drug: Alternative medications
    Medication given to treat acute agitation in the emergency department
    Other Name: Haloperidol, Serenace, Peridol, Haldon, Geodon, Ziprasidone

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects treated in the emergency department for agitation
Criteria

Inclusion Criteria:

  • All patients given antipsychotic therapy for acute agitation

Exclusion Criteria:

  • None
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504450


Sponsors and Collaborators
Advocate Health Care
Investigators
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Principal Investigator: Erik Kulstad, MD Advocate Healthcare
More Information
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Publications of Results:

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Responsible Party: Erik Kulstad, Principal Investigator, Advocate Health Care
ClinicalTrials.gov Identifier: NCT02504450    
Other Study ID Numbers: AHC6066
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Erik Kulstad, Advocate Health Care:
Bipolar 1 disorder
schizophrenia
Additional relevant MeSH terms:
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Psychomotor Agitation
Emergencies
Disease Attributes
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Haloperidol
Ziprasidone
Loxapine
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Serotonin Antagonists
Serotonin Agents