Impact of the Creation and Implementation of a Clinical Management Guideline for Personality Disorders in Reducing Use of Mechanical Restraints in a Psychiatric Inpatient Unit

ABSTRACT

Coercive measures, such as seclusion or mechanical restraints, are used with violent or agitated patients to prevent them from causing injury to self or others. In Europe, the frequency of the use of coercive measures in involuntarily admitted patients is approximately 38%, with the use of mechanical restraints varying in Western countries from 17% in Sweden to 69% in Greece.1 Despite their frequency of use, the evidence supporting the use of these measures to control violence is notably insufficient.2,3 Coercive measures have a negative psychological impact on patients, may undermine the doctor-patient relationship, and, although not well demonstrated, may be associated with clinical complications including death.4 There is general agreement that the use of coercive measures should be reduced1,2 or even discontinued.4 However, most clinical trials focused on reductions of coercive measures tend to show only moderate results.5-9 Methodological limitations10,11 are hard to avoid and complicate clinical trials and general research in the field.

Patients with personality disorders are at a high risk for experiencing coercive measures.1,12,13 The aim of the present study was to assess whether the implementation of a clinical management guideline for severe personality disorders in a psychiatric inpatient unit could reduce the frequency of the use of mechanical restraints.

METHOD

This retrospective study was conducted in a psychiatric inpatient unit with 42 beds, which serves an urban area of 330,000 inhabitants. The sample consisted of all patients with a clinical diagnosis of personality disorder (DSM-IV-TR criteria), who were admitted to the unit from January 2010 to December 2010 and from January 2011 to December 2011 (ie, before and after, respectively, the full implementation of the guideline).

The main steps of the process were as follows: one of the authors (M.A.G.T.) prepared a first draft of a clinical guideline after extensive talks with several key staff members, during which their concerns were documented. Through the guidelines, we attempted to address these concerns using an interpersonal understanding of the clinical situations based on Kernberg’s group proposals about personality organizations and transference-focused psychotherapy.14 Several meetings involving key personnel and other staff members were arranged in the last quarter of 2010 (2 per month) to discuss points of disagreement and problems regarding implementation. The goal was to reach a feasible and useful procedure to manage behavioral problems of patients with personality disorders in the unit. Thus, strictly speaking, implementation began gradually in the last quarter of 2010, in parallel to the production of the final version of the clinical guideline. This final version of the guideline was completed at the end of December 2010. The guideline focused on cluster borderline personality disorders. The guideline includes specific recommendations for the therapeutic management of patients across several stages (ie, the emergency department, admission to the unit, follow-up during the stay, and discharge). The guideline does not address the use of coercive measures; rather, it focuses on reducing interpersonal conflicts. The guideline is included in Supplementary Appendix 1.

Nurses routinely recorded the data used for this analysis during the patients’ stay. Patients were diagnosed by the psychiatrists, who were in charge of the development and implementation of the treatment plan, starting with a detailed explanation to the patient of the purpose and conditions of the treatment. During the study period, the staff personnel from the unit remained unchanged.

• Mechanical restraints can be psychologically harmful for patients and staff, and use should be kept to a minimum.
• A clear agreement at admission between patients, especially those with personality disorders, and staff regarding treatment goals, rights, and obligations and collaboration among staff members may reduce the use of mechanical restraints.

Data are presented using descriptive statistics. To compare the results before and after the intervention, we calculated the relative risk (RR) and the absolute risk reduction (ARR) with their corresponding 95% confidence intervals (CIs) for the use of mechanical restraints and discharges against medical advice. The difference in the mean number of hospital stays with its corresponding 95% CI was also calculated. All of the analyses were performed using the statistical package SPSS, version 20 (IBM Corporation, Armonk, New York). The study design was approved by the Ethics Committee of Basurto University Hospital, Bilbao, Spain.

RESULTS

A total of 878 patients were admitted to the unit during 2010, 87 (9.7%) with a diagnosis of personality disorder. The corresponding numbers for 2011 were 871 and 112 (12.9%), respectively. Cluster B personality diagnoses comprised two-thirds of the sample in both years, with borderline personality disorder being the most prevalent. Proportions did not show significant differences. The patients included young adults, with a slight predominance of males in the year before the intervention; only a minority were married or had a stable partner, and only a minority were active (Table 1). Regarding clinical characteristics, there were no relevant differences between the patients before and after the intervention (Table 1). Specifically, the number of previous admissions, previous suicide attempts, use of drugs, or family psychiatric history did not show statistically significant differences.

The proportion of patients with personality disorders requiring mechanical restraints in the unit was reduced from 38 of 87 patients admitted before the intervention (43.7%) to 3 of 112 patients admitted in the year after the intervention (2.7%), for an RR of 0.06 (95% CI, 0.02-0.19) and an ARR of 41% (95% CI, 29.9%-51.6%). There were no significant differences in the duration of stay between the patients before and after the intervention (Table 1). However, the risk of being discharged against medical advice increased after the intervention, with an RR of 1.84 (95% CI, 0.96-3.51). There was also a reduction in the use of mechanical restraints in patients without a diagnosis of personality disorder, from 43% to 4.3% (RR of 0.10; 95% CI, 0.07-0.14; ARR of 38.6%; 95% CI, 34.8%-42.5%). In these latter patients, there were no differences before and after the implementation of the guideline in the length of stay (15.8 vs 15.1 days) or in the proportion of patients who were discharged against medical advice (4.4% vs 3.8%).

DISCUSSION

Use of mechanical restraints in patients with personality disorders admitted to a psychiatric inpatient unit was dramatically reduced the year after the implementation of a clinical management guideline on personality disorders compared to the previous year. This result was accompanied by a slight increase in the risk of being discharged against medical advice. The reduction appeared gradually; in fact, it started during the implementation period at the end of the first year of the study.

The frequency of the use of mechanical restraints in patients with personality disorders in our unit before the implementation of the guideline (43.7%) was similar to the rate reported in a previous study with 2 Spanish centers in 421 patients who had several psychiatric diagnoses (37%)1 and to the rate reported in patients who had borderline personality disorders (35%) in a state psychiatric hospital in New York.13 The implementation of the clinical guideline practically abolished the use of mechanical restraints in the year after its implementation, suggesting that this may be an effective intervention for reducing the use of coercive measures with psychiatric inpatients. Other specific programs for patients with personality disorders, such as establishing a specialized ward, have also been effective for reducing the use of coercive measures with psychiatric inpatients.15 However, in our study, the reduced frequency in the use of mechanical restraints was also evident for patients with psychiatric diagnoses other than personality disorders. This finding suggests that, to a great extent, our results could be attributed to a nonspecific effect of the implementation of the guideline, for instance, a change in the therapeutic environment, which has been shown to be effective in reducing the use of coercive measures in previous studies.16 This fact is consistent with the opinion that the use of coercive measures is based more on cultural factors or policies than on medical or safety requirements.1,17

These results go beyond our expectations, and we do not fully understand the causes behind such an important effect. However, we think the fundamental ingredient might be the team approach to design and implementation (ie, the process itself). Many staff members participated in the creation and dissemination of the guideline and developed a new clinical attitude. Rather than using a top-down procedure (“we have designed this excellent guideline and you should now apply it in your clinical practice”), we tried to use a bottom-up procedure. There was a previous specific interest in our unit about management of patients with personality disorders and of situations that ended in the use of mechanical restraints; so, the guideline and its dissemination became a logical next step in an ongoing evolution and was welcomed by the team. Regarding the generalization of the effect to all patients, it is possible that staff members have extended their new attitude to all kinds of patients in the ward. This is a logical process, as many of the suggestions included in the guideline involve general principles that can be very naturally applied to patients without personality disorders.

It is important to keep in mind that we are not practicing a new way to deal with violent behavior. We are approaching patients with personality disorders with a different attitude that seems to reduce violent behavior. Once violence appears, we act as before, using the traditional responses common to most inpatient units: reduction of stimuli, verbal support-holding, permanence of the patient in his/her room (with or without the company of a staff member, depending on the case), medication, and/or mechanical restraint as a last resort intervention.

The increased risk of being discharged against medical advice that occurred after the implementation of the guideline raises some concern. Reasons for this type of discharge, especially in the second year of the study, were mainly due to failure of the patient to maintain the conditions of treatment agreed upon at admission. Issues regarding drug use, respect to other patients and staff, and participation in therapeutic activities were common in those cases. Patients who are discharged against medical advice are at a greater risk for readmission and show poorer outcomes on a number of dimensions of functioning.18

The major limitations of our study are its observational design and the lack of a concurrent control group. In addition, our encouraging results should be replicated with larger samples and in other settings, and the stability of the results across time as well as the long-term clinical outcomes should be further evaluated. We consider the guideline as a means through which a much-needed discussion and collaboration process was established among staff members, collecting some of the existent anxieties and giving our professionals a new way of dealing with interpersonal conflicts with patients. A possible replication of this study would require as a key factor a repetition of the whole process of guideline collaborative construction and not just the dissemination of the document itself. Mechanical restraints are the end result of an interpersonal conflict with many intervening factors. Every treatment team in every inpatient unit lives in a specific atmosphere with individual and group differences that should be addressed if we are to change long-standing behaviors. In the meantime, the results of our study suggest that an important reduction in the use of mechanical restraints in psychiatric inpatient units can be possible.

Author affiliations: Department of Neuroscience, University of the Basque Country, Bilbao, Spain (Drs Gonzalez-Torres, Fernandez-Rivas, and Bustamante); Psychiatry Service, Basurto University Hospital, Bilbao, Spain (Drs Gonzalez-Torres, Fernandez-Rivas, and Bustamante; Mss Vivanco, Martinez, Martí­n, and Herrera; and Mssrs Vecino, Rodriguez, and Saenz); and Neuroscience Institute, Granada University, Granada, Spain (Dr Rico-Vilademoros).

Potential conflicts of interest: None reported.

Funding/support: None reported.

Supplementary material: See accompanying pages.

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