Self Reported Level of Agitation of Patients Presenting to an Emergency Department

Status unconfirmed

Conditions studied: Psychiatric Issue

In brief

In recent years, there has been an emphasis on assessing patient's pain on presentation to emergency departments. The Joint Commission mandates that all patients who present with pain must have a pain assessment performed and addressed early in their care. Most emergency departments are using a self-reported assessment of pain using a 1-10 scale of pain. This self-reported level of pain is used to determining appropriate treatment. The Joint Commission has only dealt with somatic pain and has not addressed psychological related pain. Many authors have written on psychological pain. It is described as introspective experience of negative emotions such as anger, despair, fear, grief, shame, guilt, hopelessness, loneliness and loss. The assessment of psychological pain has been used to describe patients with depression and suicidal thoughts and behaviors. Study Significance The significance of this study is to determine if patients can communicate the level of psychological pain using the level of agitation as a surrogate marker. Studies have demonstrated that the staff's assessment of a patient's level of agitation is not based on an agitation scale nor uses any patient self-assessment of their level of agitation. If a self-assessment of a patient's level of agitation can be determined early in their care in the emergency setting, a proactive approach to treatment can occur. Proactive agitation treatment has the potential of reducing a patient's agitation and increasing their level of comfort. This early intervention can reduce the progression of agitation and the risk of injury to patients, families and staff. Hypothesis The study null hypothesis is that the self-rated agitation scale will not have a significant level of correlation with the other measures of agitation (Brief Agitation Measure, Positive And Negative Syndrome Scale and Agitation Calmness Evaluation Scale). The secondary null hypothesis is that there is no difference between the level of agitation and the level of psychological pain, assessed with the Psychological Pain Assessment.

Key facts

Study ID

NCT02713100

Run by

Leslie Zun, MD

People needed

200

Starts

2014-10-01

Expected to finish

2017-12-01

Last updated by the study team

2017-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients can be enrolled in the study only if they meet all of the following criteria:
• Presenting with a psychiatric complaint.
• Male or female patients at least 18 years of age.
• Patients must be emergency department patients during the study.
• Each patient, or a patient's legal representative (as allowed by local law), must understand the nature of the study and must agree to study enrollment.
• English speaking.
• Consenting

You may not qualify if…

• Unstable patients
• Patients who have delirium or dementia will be excluded because of its complicated medical rather than psychiatric etiologies.
• Prisoners
• Pediatric patients

Where it is running

• Mount Sinai Hospital — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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