Outcomes of Antipsychotic Medication Used in the Emergency Department

Agitation,Psychomotor Clinical Trial

— OAMED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504450
• Other study ID #: AHC6066
• Status: Completed
• Phase: N/A
• First received: July 17, 2015
• Last updated: July 27, 2016
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients given antipsychotic therapy for acute agitation

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Emergencies
• Psychomotor Agitation

Intervention

Drug:
• Adasuve
Inhaled medication to treat acute agitation in the emergency department
• Alternative medications
Medication given to treat acute agitation in the emergency department

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

References & Publications (2)

Dinh KV, Myers DJ, Noymer PD, Cassella JV. In vitro aerosol deposition in the oropharyngeal region for Staccato loxapine. J Aerosol Med Pulm Drug Deliv. 2010 Aug;23(4):253-60. doi: 10.1089/jamp.2009.0814. — View Citation

Valdes J, Shipley T, Rey JA. Loxapine inhalation powder (adasuve): a new and innovative formulation of an antipsychotic treatment for agitation. P T. 2014 Sep;39(9):621-3, 648. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in the emergency department	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.	No
Secondary	Disposition	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.	No