Needs Assessment: Much to the chagrin of many, restraints are still being utilized in the acute care setting in order to reduce violent behavior. However, it is unknown if the use of restraints increases or decreased the level of agitation that patients experience. This study determines the effect of restraint use on patients’ levels of agitation.

Learning Objectives:
• Understand the level of agitation associated with the use of restraints.
• Review the methods to measure the level of agitation that patients exhibit.
• Determine the effect of the addition of chemical modulation to patients’ levels of agitation.

Target Audience: Primary care physicians and psychiatrists.

CME Accreditation Statement: This activity has been planned and implemented in accordance with the Essentials and Standards of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Mount Sinai School of Medicine and MBL Communications, Inc. The Mount Sinai School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation: The Mount Sinai School of Medicine designates this educational activity for a maximum of 3 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Faculty Disclosure Policy Statement: It is the policy of the Mount Sinai School of Medicine to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material.

This activity has been peer-reviewed and approved by Eric Hollander, MD, chair and professor of psychiatry at the Mount Sinai School of Medicine, and Norman Sussman, MD, editor of Primary Psychiatry and professor of psychiatry at New York University School of Medicine. Review Date: January 14, 2008.

Drs. Hollander and Sussman report no affiliation with or financial interest in any organization that may pose a conflict of interest.

To receive credit for this activity: Read this article and the two CME-designated accompanying articles, reflect on the information presented, and then complete the CME posttest and evaluation. To obtain credits, you should score 70% or better. Early submission of this posttest is encouraged: please submit this posttest by February 1, 2010 to be eligible for credit. Release date: February 1, 2008. Termination date: February 28, 2010. The estimated time to complete all three articles and the posttest is 3 hours.

Dr. Zun is chairman and professor of emergency medicine in the Department of Emergency Medicine at Rosalind Franklin University of Medicine and Science/Chicago Medical School and chairman in the Department of Emergency Medicine at Mount Sinai Hospital in Chicago, Illinois. Dr. Downey is assistant professor in Public Policy at Roosevelt University in Chicago.

Disclosure: Dr. Zun is consultant to and on the speaker’s bureau of Eli Lilly. Dr. Downey reports no affiliation with or financial interest in any organization that may pose a conflict of interest.

Please direct all correspondence to: Leslie S. Zun, MD, Chair, Department of Emergency Medicine, Mount Sinai Hospital, Chicago, IL 60608; Tel: 773-257-6957; Fax: 773-257-6447; E-mail: zunl@sinai.org.

 

Abstract

Introduction: This study aimed to determine the effect of restraints on the level of agitation seen in patients restrained in the emergency department for behavioral reasons.
Methods: The convenience, observational study determined the level of patient agitation using the Overt Aggression Scale (OAS) and the Agitated Behavior scale (ABS) over a 2-hour period. The study was performed in a level 1 emergency department with 45,000 annual vis- its. The inclusion criteria included was any patient who presented to the emergency department in need of behavioral restraints; the exclusion criteria eliminated patients who were restrained for non-behavioral reasons. The study was Institutional Review Board approved.
Results:
Sixty-two physically restrained patients and 41 physically and chemically restrained patients were seen in the emergency department during the study. The average OAS score varied from 1.6935 at arrival, 1.9839 at application, and 1.4194 at 2 hours for physical restraint; and 1.9756 at arrival, 1.9512 at application, and 1.0732 at 2 hours for physical and chemical restraint. The average ABS score varied from 2.1795 on arrival, 2.20968 at application, and 1.7377 at 2 hours for physical restrained; and 2.4231 at arrival, 2.4516 at application, and 1.3793 at 2 hours for physical and chemical restrained patients. Using both the OAS (F=13.655, df=1, sig at .001) and the ABS (F=6.809, df=1, sig at .011) there was a statistically significant change at 120 minutes in the groups.
Discussion: The study demonstrated that patients who are physically and chemically restrained become more agitated when restraints are first applied, and have less agitation within 120 minutes. The addition of chemical restraint reduced the level of agitation even more than did physical restraints alone.
Conclusion: Restraint usage increased the amount of patient agitation of patients presenting to an emergency department.

 

Introduction

Agitated patients frequently present to the emergency department for evaluation and treatment. Should their agitation escalate, such patients present a violence risk to themselves and others. Most emergency physicians and psychiatrists agree that these patients need to be treated as soon as possible in order to prevent violence escalation. These patients are frequently physically and chemically restrained in the acute healthcare setting.

The incidence of using various restraints for agitation in the acute care setting is not well documented in the literature. Soloff and colleagues1 reviewed 13 published studies of adults in an inpatient psychiatric setting and found a range of 1.9% to 66% patients had a need for seclusion and/or restraint. In another study, Robbins and colleagues2 used an average of two restraints on 17% of patients in an acute medical unit. In emergency medicine, it was found that 25.2% of teaching hospitals restrained at least 1 patient/day.3 The percent of patients restrained in a psychiatric emergency room (24% to 25%) was significantly higher than that in an inpatient facility (7% to 20%).4-7 A recent study8 found an average of 3.7% of all emergency department patients needed restraint and seclusion or restraint alone.

Little information exists on the number of patients in the acute care setting whom have been given chemical agents.9 No study identified the number of patients who were only given a chemical agent rather than physical restraint to control behavior. One study demonstrated that 29.1% of the studied patients received both chemical modulation and physical restraint.10 This study did not examine the effects of restraints, chemical or physical, on the level of agitation.

The medical literature is limited as to the effects of these treatments on controlling the level of agitation, either upon presentation or after treatment. The authors of this article proposed this study in order to better understand the role and effect of chemical and physical restraints on agitation in patients in the emergency department. The null hypothesis of the study was that restraint usage does not reduce the amount of patient agitation.

 

Methods

This observational study was performed in an inner-city community teaching hospital emergency department with 45,000 annual visits. Approximately 2,000 patients were categorized as psychiatric patients and 15.2% of this number were restrained. The city’s police department designated the hospital as a referral site for psychiatric patients in the southwest side of the city.

During the summer and fall of 2003, a convenience sample of patients who presented to the emergency department and needed restraints were enrolled when a research fellow was available. An agitation checklist was used for each patient enrolled in the study (Figure). The study was approved by the institutional review board. 

 

The patients’ level of agitation was evaluated upon arrival, at the time of initial application of restraint, 10 minutes thereafter, and 120 minutes thereafter. The authors of this article chose two validated tests of agitation to determine the patient’s level of agitation in the emergency department; namely, the Agitated Behavior Scale (ABS) and the Overt Aggression Scale (OAS).11-16 These scales were chosen because of their ease of use and their limited data requirements.

The data was inputted into a Statistical Package for the Social Sciences (SPSS) program for analysis (SPSS, version 12, Chicago). To analyze data, the scales were divided into slight (0–13), minimal (14–26), moderate (27–39), and severe (40–52) for the ABS, and none (0), minimal (1–4), moderate (5–8), and severe (9–12) for the OAS. The groups were compared using analysis of variance (ANOVA) and Pearson tests.

 

Results

A total of 103 patients were enrolled in the study. More males than females, more African Americans than other racial groups, and more older than younger patients were enrolled in the study (Table 1). Some of the data fields in each case were not completed; therefore, not all of the numbers equaled the total. Sixty-two patients only received physical restraints. Forty-one patients received chemical restraints as well as physical restraint. Overall, most of the patients were 26–40 years of age (81 of 102), male (80 of 103), African American (67 of 103), restrained for <6 hours (35 of 77), schizophrenic (34 of 82), and presented with violence and agitation (18 of 101). The physical restraint group had similar characteristics overall except that the patients were >41 years of age (23 of 53) and had violent presentations (12 of 61). The chemical and physical restraint group had similar characteristics to the overall group except they presented with higher violence and agitation levels. The most common chemical agents used for restraint were haloperidol and lorazepam (19 of 41); the least was risperidone (4 of 41).

 

 

Among categories in ranking, the scores on the OAS of the patients who were physically restrained went from 1.6935 upon arrival, to 1.9839 at application, to 1.6452 at 10 minutes, and to 1.4194 at 120 minutes. For those who were physically and chemically restrained, the scores went from 1.9756 upon arrival, to 1.9512 at application, to 1.5366 at 10 minutes, and to 1.0732 at 120 minutes (Table 2). The intervals on the ABS of the patients who were physically restrained went from 2.1795 upon arrival, to 2.2097 at application, to 1.8871 at 10 minutes, and to 1.7377 at 120 minutes (Table 2). For those who were physically and chemically restrained, the scores went from 2.4231 upon arrival, to 2.4516 at application, to 1.9310 at 10 minutes, and to 1.3793 at 120 minutes.

 

In looking for differences among groups within the specific categories, the authors of this article used Pearson Chi squared correlation. After 120 minutes following application of  the OAS both groups had equal numbers (38) in the none category (Tables 3 and 4). However, during that same time period of 120 minutes, the physical alone group had 22, which is 35% of the total population in physical restraints group in the minimal 1–4 category, as compared with the physical and chemical group, with three (7%) in the same minimal category. The physical alone group also had two (3.2%) in the moderate category, as compared with none in that category for the physical and chemical group.

 

ANOVA was used in looking for differences between groups within the specific categories. A significant difference for OAS was only found at 120 minutes after restraints were done (F=13.655, df=1, sig at .001). The same was true for ABS with a significant difference at 120 minutes after restraints were applied (F=6.809, df=1, sig at .011). There was a significant difference, P=12.68, df=2, sig at .002, using the ABS, within groups upon arrival to the emergency department. Upon arrival, the two groups were about equal in the slight category, with three in the physical alone group, and four in the physical and chemical group. However, the physical alone group had 27 (69%) in the minimal category, as compared with only eight for the physical and chemical group. This pattern changed in the moderate category, with the physical alone group having eight (20%) and the physical and chemical group 13 (50%) in the same category. Using ABS at 120 minutes, there was also a difference, with P=6.58, df=2, sig at .037. At 120 minutes, the physical alone group had 23 (37%) and the chemical and physical group 18 (62%) at slight. The physical group had 31 (50%) at minimal, and the chemical and physical group only had 11 (38%) in the same category. After 120 minutes, the physical group still hadseven (11%) in the moderate category, whereas the physical and chemical group had none.

 

Discussion

This study demonstrated three interesting phenomena. First, the level of agitation was high in the both groups. Second, the level of agitation initially increased in both groups during the application of restraints. Last, the level of agitation was reduced more in the physical and chemical group than in the physical restraint group alone. It was unexpected that the level of agitation increased upon application of the restraints. The authors of this article did expect to see that there was a greater reduction in agitation in the chemical and physical restraint group than the physical only.

This study found that the level of agitation was high in both treatment groups. There are few studies that have measured the level of agitation a patient exhibits upon arrival to the emergency department. The natural history of an agitated patient without treatment has not been evaluated and a study of the natural course of an agitated patient without treatment would be valuable. Analogous to pain treatment, the level of agitation over time as measured with one of the agitation tools could be used for the basis of treatment. The treatment and doses could be better metered by this method.

It was an unexpected finding that patients became more agitated when the restraints were first applied. This finding would question whether there are better means to reduce the patient’s level of agitation. If the mantra of medicine is to “first, do no harm,” then it is necessary to find better and more humane means to reduce a patient’s level of agitation instead of the use of restraints.

The scales used in this study have rarely been used in emergency medicine to determine a patient’s level of agitation. Battaglia and colleagues9 used the ABS to assess the differences among haloperidol, lorazepam, or both in the treatment of agitation. They found that all treatment groups showed significant reduction in baseline scores over a 12-hour treatment phase. They did not examine the effect of physical restraint only, nor did they document how many patients also received this intervention. Mock and colleagues10 used the OAS to measure the number of violence episodes encountered by an emergency medical service system.

It is understandable that the level of agitation was most reduced when the patient received both physical restraint and chemical treatment. The authors of this article did not evaluate whether chemical restraint alone might have been the optimal means to reduce a patient’s agitation. The study had initially been designed to examine the effect of chemical restraint only; however, only one patient received this treatment. Many studies have demonstrated the use of various agents to control agitation in the emergency department.9-22 Two atypical intramuscular antipsychotics have been approved for use in the agitated patients with schizophrenia and bipolar disorder. Most of these studies have been limited to comparison of a new atypical agent to haloperidol with or without lorazepam in patients with known schizophrenia or bipolar disorder. A randomized, double-blind, controlled trial of undifferentiated emergency department agitated patients would be more valuable. One randomized controlled trial compared atypical and typical antipsychotics on the undifferentiated patient to determine the best agent for use in the emergency department.23 Martel and colleagues23 compared droperidol, ziprasidone, and midazolam and found midazolam inferior to the other agents.

Both the Joint Commission for Accreditation Healthcare Organizations and the Center for Medicare and Medicaid Services require that alternatives be attempted prior to the initiation of restraints, whether they are physical or chemical.24-28 These alternatives may include negotiating with patients, putting them closer to the nursing station, and offering them food. A review of the literature found few helpful studies examining the effectiveness of the use of alternatives in the reduction of restraint use.

The measurement tools for agitation limited the study presented in this article. Although the validated tools have been used to determine the level of agitation in settings outside the emergency department, their usefulness in the acute care setting has not been determined.29-38 Prior studies using the tools administered in this study have been used to determine a patient’s risk of violence rather than the patient’s level of agitation. Arrango and colleagues29 and McNeil and colleagues30 have used the OAS to determine the risk of violence in patients. The ABS has been used to evaluate brain trauma patients and demented patients, but not in patients in the emergency department.36-38 Perhaps there are other measures of agitation that would have provided better information than those that were used in this study.

This study was limited by incomplete data collection for some of the patients and by the observational nature of the study. It would have been preferred to use a randomized, controlled trial evaluating different means of treating a patient’s level of agitation. The small number of patients in each group also limited this study. The groups were not homogenous in terms of diagnosis or indication for restraints. The study was also limited by the fact that individual physicians chose the form of treatment or restraint to place the patient in, rather than the choice being determined by study protocol.

 

Conclusion

This study sets the need for further inquiry regarding the agitated patient. The best and most humane means of modulating the agitated behavior of psychiatric patients is yet to be determined. A multi-faceted prospective study aimed at examining various approaches to patients with different agitation etiologies is needed, albeit difficult to accomplish in the acute care setting. It is essential to understand that a patient may become more agitated when restraints are initially applied, and the medical staff must be prepared to deal with this. Over time, these restrained patients will become significantly less agitated with the addition of chemical agents. PP

 

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