Perspectives in Psychiatric Care
Effects of a Regulatory Protocol for Mechanical Restraint and Coercion in a Spanish Psychiatric Ward Jose Guzman-Parra, DClinPsy, Juan A. Garcia-Sanchez, RN, Isabel Pino-Benitez, RN, Mercedes Alba-Vallejo, MD, and Fermin Mayoral-Cleries, PhD Jose Guzman-Parra, DClinPsy, is Clinical Psychologist, PhD Student, Department of Mental Health, University General Hospital of Malaga, Biomedical Research Institute of Malaga (IBIMA), Malaga, Spain; Juan A. Garcia-Sanchez, RN, is Psychiatric Nurse, Department of Mental Health, University General Hospital of Malaga, Biomedical Research Institute of Malaga (IBIMA), Malaga, Spain; Isabel Pino-Benitez, RN, is Psychiatric Nurse, Department of Mental Health, University General Hospital of Malaga, Biomedical Research Institute of Malaga (IBIMA), Malaga, Spain; Mercedes Alba-Vallejo, MD, is Psychiatrist, Department of Mental Health, University General Hospital of Malaga, Biomedical Research Institute of Malaga (IBIMA), Malaga, Spain; and Fermin Mayoral-Cleries, PhD, is Psychiatrist, Department of Mental Health, University General Hospital of Malaga, Biomedical Research Institute of Malaga (IBIMA), Malaga, Spain.
Search terms: Acute psychiatry, coercion, mechanical restraint, psychiatric inpatient Author contact: [email protected]
, with a copy to the Editor: [email protected]
Conflict of Interest Statement The authors report no actual or potential conflicts of interest. No funding was received. First Received May 15, 2014; Final Revision received August 25, 2014; Accepted for publication September 17, 2014.
PURPOSE: There is still limited information on what type of measures are most efficient to reduce coercion. The aim of this study was to determine if the introduction of a new regulatory protocol in a specific psychiatric ward in Andalusia (Spain) contributed to reducing the use of mechanical restraint. DESIGN AND METHODS: The study included a comparison of two time periods: 2005 (one year before the implementation of the new regulatory protocol) and 2012, in all hospitalized patients (N = 1,094). The study also analyzes with logistic regression the variables related to a shorter duration of mechanical restraint. FINDINGS: Mechanical restraint rate per year was reduced, not significantly, from 18.2% to 15.1%. The average duration of each mechanical restraint episode was significantly reduced from 27.91 to 15.33 hr. The following variables have been associated with a shorter period of coercion: being female and the year of restraint (2012). PRACTICE IMPLICATIONS: Specific plans are required, including different interventions, in order to achieve marked reduction in the use of coercive measures.
Despite general changes in ethical principles and international law for treating psychiatric patients within the least restrictive environment possible, the use of coercive measures is still extended in psychiatric inpatient facilities (Beghi, Peroni, Gabola, Rossetti, & Cornaggia, 2013). Among them, mechanical restraint remains the most controversial, given the lack of empirical evidence of safety and effectiveness of this intervention and its potential harmful effects (Bergk, Einsiedler, Flammer, & Steinert, 2011; Georgieva, Mulder, & Whittington, 2012; Huf, Coutinho, & Adams, 2012; Nelstrop et al., 2006). The term “restraint” is used in the literature to refer to mechanical restraint techniques, such as belts or straps, used in order to manage agitated or violent behavior and to prevent self-harm or the hurting of others. Studies on restraint application conducted across Europe and the United States report significant variations in restraint rates (Steinert et al., 2010). These variations have been attributed more to culture, traditions, and policies than to medical or safety requirements (Frueh et al., 2005). People who have experienced restraint report its traumatiz260
ing nature (Olofsson & Jacobsson, 2001; Sørgaard, 2004) and advocate its abolition in mental health systems oriented toward recovery (Curie, 2005). During the last 15 years, clinicians, hospital administrators, and health authorities have raised concern about physical restraint and have developed recommendations and strategies to reduce its use in clinical practice (Stewart, Van der Merwe, Bowers, Simpson, & Jones, 2010), for example, interventions based on staff training (Kontio, Pitkänen, Joffe, Katajisto, & Välimäki, 2014). Reduction of the rate of restraint is considered a measure of quality and a good clinical practice in most psychiatric facilities (Glover, 2005). There are many studies analyzing the changes introduced in psychiatric settings to reduce restraint and other coercive interventions, such as seclusion and forced medication (Gaskin, Elsom, & Happell, 2007; Stewart et al., 2010). In Spain, restraint is the second most used coercive measure after forced medication. The third measure is seclusion (Raboch et al., 2010). Different policies including regulatory measures have been proposed to reduce or minimize Perspectives in Psychiatric Care 51 (2015) 260–267 © 2014 Wiley Periodicals, Inc.
Effects of a Regulatory Protocol for Mechanical Restraint and Coercion in a Spanish Psychiatric Ward
the use of restraint during hospitalization (Stewart et al., 2010). Those policies advocate the implementation of standard procedures and monitoring data to achieve these objectives. In 2005 (updated in 2010), a new regulatory protocol (Servicio Andaluz de Salud, 2010) was implemented by Health Authorities in the region of Andalusia (Spain). This study aims to explore whether a mandatory regulatory protocol can modify the use of restraint in inpatient psychiatric units and to evaluate different variables related to restraint application. Method Setting The study was conducted in the psychiatric ward of the General University Hospital of Malaga (Spain). The ward has 42 beds for patients in need of acute psychiatric hospitalization. It is the only adult psychiatric hospitalization ward in a catchment area of 500,000 inhabitants. Throughout the study period, there were no changes in the number of beds and staff. Design The study design was a retrospective comparative analysis of the mechanical restraint episodes. The total number of episodes of mechanical restraint was taken as the unit of analysis to evaluate modifications in the use of mechanical restraint after the implementation of the new regulatory protocol in the ward. We compared the number of restraint episodes that had occurred in 2005, the year before the implementation of the new regulatory protocol, with the number of restraint episodes registered 7 years later (2012) in the same hospital unit. The mechanical restraint procedure in 2005 was developed in accordance with the protocol of the ward, and in 2012, in accordance with the new protocol of the Andalusian Health Service (Servicio Andaluz de Salud, 2010), published in 2005 and updated in 2010. This new mandatory regulation was introduced by regional Health Authorities in the framework of the Patient Autonomy Basic Act (Ley básica reguladora de autonomía del paciente) (41/2002). It contains a set of rules and recommendations for ensuring correct application and evaluation of this measure in all psychiatric hospital wards in the entire region of Andalusia. Mechanical Restraint Definition. Mechanical restraint is defined as the application of mechanical fastening devices to limit physical mobility in order to prevent damage to the patient, other people, and/or the physical environment that surrounds them. Differences With the Previous Protocol and Implementation. Until the publication of the Andalusian protocol, the Perspectives in Psychiatric Care 51 (2015) 260–267 © 2014 Wiley Periodicals, Inc.
ward had employed its own protocol. The new protocol stated the need to register each episode (in a harmonized system throughout the region of Andalusia) and analyze the data related to restraints. Previously, a record similar to that indicated by the new protocol was used to register restraints. However, for the first time, the data of 2005 were analyzed, as recommended in the protocol. One of the major changes compared with the older protocol involves the restrictions of the indications for use; the new protocol specifies less susceptible restraint situations and is thus more restrictive. Moreover, the new protocol demanded that the maximum duration of the measure should be 4 hr and should be revised by the psychiatrist for time extension (in the old protocol, the maximum duration was not specified). Also, a time of assessment by nurse every 15 min was set compared to the previous 30 min, and compulsory medical assessment was set an hour from starting time, compared to the 2 hr specified in the old protocol. The new protocol also includes the need for vigilance and constant monitoring, preferably with a video camera. For the implementation of the protocol, no specific training plan or formal education was offered; however, staff coordinators provided written information about the protocol and indicated a commitment to having all staff understand and implement the new protocol. Ethical Issues This study was approved by the Hospital Ethics Committee in Malaga. Informed consent was not considered an obligatory requirement, given that the information used in the study had been obtained retrospectively from the mandatory administrative records of each mechanical restraint episode. Variables The following variables were extracted from patients’ medical records: age, gender, date and time of immobilization (8:00– 15:00,15:00–22:00 and 22:00–8:00),reasons for restraint (selfinjury/autolysis risk, violent behavior/preventing physical damage,request of the patient,behavioral problems,and other reasons),patient cooperation,medication,staff involved in the restraint, time of suspending the measure, and diagnoses (according to ICD-10). Procedure Every episode of mechanical restraint must be registered in the patient’s medical record, which shall contain the circumstances that led to the adoption of the measure and its maintenance over time. For this purpose, specific and approved templates have been used. Law 41/2002 states that these documents should contain all the circumstances related to the restraint. Every professional involved in mechanical restraint 261
Effects of a Regulatory Protocol for Mechanical Restraint and Coercion in a Spanish Psychiatric Ward
must record their intervention. In both 2005 and 2012, the records of each mechanical restraint episode were collected in duplicate, one copy for clinical history and the other to be inserted into a database for further analysis. Statistical Analyses The following tests were used to analyze categorical variables: chi-square (χ2) test and Fisher’s exact test when less than 80% of the expected frequencies of the cell were greater than 5. In contrast, for quantitative variables, the nonparametric Mann–Whitney test or Student’s t-test was used. In addition, a binary logistic regression analysis was conducted, using the duration of mechanical restraint (< 8 hr vs. a longer time) as a dependent variable. The first step was to carry out a univariate analysis with the following independent variables: age, sex, time period when the restraint was applied (morning, afternoon, or evening), day of the week when the restraint started and ended (weekday or weekend), patient cooperation, co-administered medication, personnel performing the restraint (nurses vs. nurses and other staff), reasons for restraint, and year of restraint. The second step was to introduce significant variables (p < .1) in the regression model with different years and with the complete episodes, always controlling for age and gender. R version 3.0.2 and R commander version 2.0-0 for Windows were used. The level of significance was set at .05 (two-sided). Results Analysis of the sociodemographic and clinical data of all patients admitted to the psychiatric ward (N = 1,094) shows
Sex Age (mean) Age < 24 25–34 35–44 45–54 > 55 Diagnosis Substance disorders (F10–F19) Psychotic disorders (F20–F29) Affective disorders (F30–F39) Anxiety disorders (F40–F49) Personality disorders (F60–F69) Other psychiatric diagnosis
2005 (%) N = 550
2012 (%) N = 544
F = 216 (39.3) M = 334 (60.7) 41.03 ± 12.98 (M ± SD)
F = 226 (41.5) M = 318 (58.5) 42.63 ± 12.89 (M ± SD)
51 134 160 126 77
(9.3) (24.5) (29.2) (23) (14.1)
51 98 166 133 96
(9.4) (18) (30.5) (24.4) (17.6)
88 195 140 45 44 38
(16) (37.1) (25.5) (8.2) (8) (6.9)
56 202 143 39 43 61
(10.3) (35.5) (26.3) (7.2) (7.9) (11.2)
relevant homogeneity between the two years (Table 1). In 2005, there were 550 hospitalized patients (accounting for 821 hospitalization episodes). In 2012, there were 544 hospitalized patients (accounting for 732 hospitalization episodes). Differences were found in age (Z = −2.43, p < .05), but when age intervals were analyzed, no significant differences were found (χ2 = 8.01, p = .09). Analysis of the variable “diagnoses” showed that admissions for “substance disorders” (F10–F19) decreased in 2012 when compared to 2005 (χ2 = 7.79, p < .01), while “other psychiatric diagnoses” increased (χ2 = 6.16, p < .05). In 2005, 100 patients were restrained (accounting for 148 restraint episodes), and in 2012, a total of 82 patients were restrained (accounting for 164 restraint episodes). The mean age in the total of restrained patients was 37.40 (SD = 12.26) years. The analysis of the population of restrained patients brought no significant differences in sociodemographic variables (Table 2). Most of the restraints were applied to patients aged between 25 and 45, which constitutes more than 50% of the total of restraint episodes. Although the rate of non-Spanish people admitted was 9.5%, they constituted more than 25.6% of all restraint episodes (only data from 2012 were collected). The most common diagnosis in both years were “psychotic disorders” (F20–F29), followed by “affective disorders” (F30–F39) and “substance disorders” (F10–F19). The percentage of patients restrained in 2005 was 18.2%, compared to 15.1% in 2012 (χ2 = 1.90, p = .17), with an odds ratio (OR) (2012 vs. 2005) of 0.80 (CI = 0.58–1.01; 95%). The mean duration of each mechanical restraint episode decreased from 27.91 hr in 2005 to 15.33 hr in 2012 (Z = −0.52, p < .01), and the total number of restraint hours
Table 1. Sociodemographic and Clinical Variables of All Patients Admitted per Year