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

NCT02713100 | Unknown

• 1 other identifier: 14-15
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychiatric Issue

Outcome Measures

Primary Outcomes (1)

• Brief Agitation Measure

  The Brief Agitation Measure is a three question tool: (1) I want to crawl out of my skin,(2) I feel so stirred up inside I want to scream and (3) I feel a lot of emotional turmoil in my gut. Each item is scored from 1-7 so the scores are from 3-21. Higher scores are considered great level of agitation.

  5 MINUTES

Secondary Outcomes (1)

• Positive and Negative Syndrome Scale

  3 hours

Other Outcomes (2)

• Agitation Calmness Evaluation Scale

  15-20 minutes

• Psychological Pain Assessment Scale

  3 hours

Interventions

level of agitation BEHAVIORAL

psychological pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of patients who presented with psychiatric complaints to the emergency department when a research fellow from the Department of Emergency Medicine is available in the ED will be enrolled in the study.

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

Sponsors & Collaborators

• Leslie Zun, MD: lead
• Teva Pharma: collaborator

Study Sites (1)

Mount Sinai Hospital

Chicago, Illinois, 60608, United States

RECRUITING

Related Publications (4)

• Shneidman ES. The psychological pain assessment scale. Suicide Life Threat Behav. 1999 Winter;29(4):287-94. No abstract available.

  PMID: 10636323 BACKGROUND

• Mee S, Bunney BG, Bunney WE, Hetrick W, Potkin SG, Reist C. Assessment of psychological pain in major depressive episodes. J Psychiatr Res. 2011 Nov;45(11):1504-10. doi: 10.1016/j.jpsychires.2011.06.011. Epub 2011 Aug 9.

  PMID: 21831397 BACKGROUND

• Shattell MM. Why does "pain management" exclude psychic pain? Issues Ment Health Nurs. 2009 May;30(5):344. doi: 10.1080/01612840902844890. No abstract available.

  PMID: 19437255 BACKGROUND

• Flor H. Psychological pain interventions and neurophysiology: implications for a mechanism-based approach. Am Psychol. 2014 Feb-Mar;69(2):188-96. doi: 10.1037/a0035254.

  PMID: 24547804 BACKGROUND

Study Officials

• Les Zun, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Zun, MD

CONTACT

7732576957; zunl@sinai.org

Jamie Doucet, MPH

CONTACT

7732576130; jamie.doucet@sinai.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: March 18, 2016
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)