Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02713100 |
| Other study ID # |
14-15 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
October 20, 2014 |
| Last updated |
March 21, 2017 |
| Start date |
October 2014 |
| Est. completion date |
December 2017 |
Study information
| Verified date |
March 2017 |
| Source |
Mt Sinai Hospital, Chicago |
| Contact |
Leslie Zun, MD |
| Phone |
7732576957 |
| Email |
zunl[@]sinai.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
In recent years, there has been an emphasis on assessing the patient's pain when the patient
presents 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 determine appropriate treatment. The
Joint Commission has only dealt with somatic pain and has not addressed psychological pain.
Psychological pain is described as the 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
symptoms.
Some in the field of emergency psychiatry believe patients who are agitated are exhibiting
psychological pain, which some argue is no different than somatic pain. However, the
principle of somatic pain assessment and treatment has never been applied to the assessment
and treatment of psychological pain. Addressing a patient's level of agitation could be used
to reduce their agitation and thereby, reduce their psychological pain.
Psychiatric patients frequently present to emergency departments (ED) across the country.
Many of these patients are agitated, necessitating treatment for their agitation in the ED.
Agitation is thought to be one way a patient expresses psychological pain. If one could
assess and treat a patient's agitation, one may be able to reduce psychological pain.
Patients may exhibit various levels of agitation from mild to severe. Patients may progress
from one level to the next or stay in one level. Moderate and severely agitated patients are
difficult to evaluate and usually need treatment for their agitation. Some of these patients
may become violent and injure themselves, staff or others. It is essential to identify
patients who might be in the mild to moderate stage in order to prevent progression to
severe agitation. This identification can provide a mechanism to determine who needs
immediate treatment in the ED.
The treatment for these agitated patients frequently includes physical restraint, chemical
treatment and seclusion. In a review of 13 published studies of adults in a patient
psychiatric setting, a range of 1.9% to 66% patients had a need for seclusion and restraint.
Another study found an average of 2 restraints on 17% of patients in an acute medical unit.
In psychiatric emergency rooms, the percent of patients restrained (20-25%) was
significantly higher than in an inpatient facility (7-20%) [8-11]. It was found 25.2% of
teaching hospitals restrained at least one patient per day. An average of 3.7% of all ED
patients needed restraint and seclusion, or restraint alone.
Although not frequently used in the emergency setting, there are many tools used to
assessment agitation in the acute care setting including Brief Agitation Tool, Positive and
Negative Syndrome Scale-Excited Component, Agitation Calmness Evaluation Scale, Richard
Agitation Sedation Scale, Overt Agitation Severity Scale, and Agitation Behavior Scale.
Only one of these tools, Brief Agitation Tool, has been used to obtain a self-reported
measure of agitation. However, this tool has been used only on students and outpatients; not
in the emergency setting. Also, the tool was used to correlate agitation to suicidal
symptoms.
Tools to measure a patient's psychological pain are limited. These include the Psychological
Pain Assessment Scale and the Psychological Pain Assessment. These tools have been used in
the study of depression and suicidal symptoms. It has not been evaluated on ED patients
presenting with agitation.
The purpose of this study is to apply the same principle of assessing somatic pain to
psychological pain using the level of agitation as a surrogate marker. This study will
compare a self-rated agitation scale to the other measures of agitation (Brief Agitation
Tool, Positive and Negative Syndrome Scale-Excited Component, and Agitation Behavior Scale).
An analysis of the data will provide information concerning the accuracy of a
self-administered scale in assessing agitation. The secondary purpose will to determine the
correlation of a measure of psychological pain (Psychological Pain Assessment) to level of
agitation.
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. If a self-assessment of a patient's level of agitation can be determined early their
care in the emergency setting, a proactive active 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. The secondary null
hypothesis is that there is no difference between the level of agitation and the level of
psychological pain.
Methods The study is a prospective enrollment with use of medical records & convenience
sample of patients who present to the ED with a psychiatric complaint to determine their
level of agitation and psychological pain. This study will be performed in a community,
inner city teaching hospital ED with 55,000 visits per year. The city's police department
has designated the hospital as the referral site for psychiatric patients in the southwest
side of the city.
All patients will be evaluated by the emergency physician to provide medical clearance. The
behavioral health service begins their psychiatric evaluation of the patient simultaneously
with the medical clearance process. The behavioral health evaluation will determine the need
for psychiatric admission together with the emergency service.
The emergency service is responsible for the evaluation and treatment of a patients'
agitation. A treatment protocol with a scale of agitation is used to guide the physician
into whether to restrain or medicate a patient as well as the type and dosage of medication.
A convenience sample of patients who present with psychiatric complaints to the emergency
department when a research fellow from the Department of Emergency Medicine is available
will be enrolled in the study.
Inclusion/Exclusion Criteria
Patients can be enrolled in the study only if they meet all of the following criteria:
1. Presenting with a psychiatric complaint.
2. Male or female patients at least 18 years of age.
3. Patients must be emergency department patients during the study.
4. 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.
5. English speaking.
6. Consenting
Patients will be excluded from the study for any of the following reasons:
1. Unstable patients
2. Patients who have delirium or dementia will be excluded because of its complicated
medical rather than psychiatric etiologies.
3. Prisoners
4. Pediatric patients The research fellow will obtain consent from the patient or their
surrogate and ensure that the patient meets all study inclusion and no exclusion
criteria. The researcher will provide a brief overview of the study to the patient to
obtain verbal consent.
Information will be collected on a data collection sheet that will include basic demographic
information on the patient: age, gender, diagnosis, current medication, restraint usage,
time restraints were applied and type, dose and time medication is administered. A research
fellow will complete the data collection sheet and input the data of enrolled patients into
a database. The statistician will perform an analysis of the data looking for statistical
significance of the data to the posed questions. Once all data is collected, any identifying
information on the patient will be destroyed to ensure patient confidentiality.
The research fellow will be responsible for completing an agitation checklist on each
patient enrolled in the study. The patients' psychiatric diagnosis will be noted from the
psychiatric service.
The patients were evaluated for their level of agitation at arrival and every 30 minutes for
2 hours. We will use four tests of agitation: Brief Agitation Tool, Positive and Negative
Syndrome Scale-Excited Component, Agitation Behavior Scale, and the Psychological Pain
Assessment Scale.The independent variables will be diagnosis, number of restraints
administered (if any), time intervals every 30 minutes of each test, type of medication
administered ( if any), and time to non-agitated state level on each scale. The dependent
variables would be the assessing psychic pain using the level of agitation as a surrogate
marker.
The data will be inputted into a Statistical Program for Social Science program for
analysis. Group differences between cases and levels of agitation will be examined by
two-tailed t-tests and analysis of variance. Analysis of variance and its derivatives will
be used to determine what, if any, differences exist between the patient's agitation and
psychological pain scale assessments at 30 minute intervals up to the two hour mark. Because
the relation between the predictor and outcome variables is not presumed to be a linear
function, the measure of association between the outcome of interest and the predictor
variable is represented by an odds ratio instead of a multiplicative factor. Comparisons of
odds ratio between predictor variables help determine the factors of greatest importance,
while their confidence intervals will indicate their statistical significance. This will
determine the probability of which test will accurately predict the lowering levels of
agitation at timed intervals as compared to each other and to the dependent variable.
Additionally, it can predict any correlations to the independent variables which may
influence the outcomes such as gender, age and diagnosis.
