Association Between Restriction of Involuntary Medication and Frequency of Coercive Measures and Violent Incidents
Abstract
Objective:
In the German federal state of Baden-Wuerttemberg, involuntary medication of psychiatric inpatients was illegal during eight months from July 2012 until February 2013. The authors examined whether the number and duration of mechanical coercive measures (seclusion and restraint) and the number and severity of violent incidents changed in this period.
Methods:
A cross-sectional analysis was conducted of admission-related routine data collected in seven psychiatric hospitals in three time periods (period 1, July 2011–February 2012; period 2, July 2012–February 2013; and period 3, July 2013–February 2014). All patients with psychotic disorders and at least one admission during at least one of the three time periods were included (N=2,071), for a total of 3,482 admissions.
Results:
The mean number of mechanical coercive measures and violent incidents per admission increased significantly during period 2, when involuntary medication was not possible, and decreased significantly during period 3. They also differed significantly between periods 1 and 3. The percentage of admissions involving seclusion increased during period 2 significantly and was significantly different during period 1 compared with period 3. The severity of illness and the length of hospitalization did not change over the three periods.
Conclusions:
Restriction of involuntary medication was associated with a significant increase in use of mechanical coercive measures and violent incidents.
Involuntary medication and other kinds of involuntary treatment pose an ethical conflict between the patient’s autonomy and beneficence (1). In most developed countries, jurisdiction and legislation have tended to increase the threshold for involuntary medication, requiring formal decision making by a judge and separating involuntary treatment from involuntary commitment (2–4).
In Germany, coercive interventions in psychiatry are regulated either through federal civil law authorizing the use of guardianship in cases of lack of capacity and danger to one’s health or through public state laws in case of acute danger to self or others. Civil law is valid throughout Germany, whereas public state laws differ somewhat among the German federal states. If the need for guardianship is judicially confirmed, civil law precedes. In 2011, the German Constitutional Court decided that the public law in the State of Baden-Wuerttemberg regulating involuntary medication during involuntary commitment violated individual constitutional rights by not sufficiently taking into account a patient’s capacity to consent and by not ensuring that involuntary medication be used only as a last resort after the failure of all other approaches.
In July 2012, the German Supreme Court ruled that these principles must be applied to all existing federal and state laws. Therefore, involuntary medication authorized on the basis of the federal law on guardianship was also no longer permitted. As a consequence, in Baden-Wuerttemberg, with its 10 million inhabitants, there was no legal basis for involuntary medication except in acute emergencies until revised legislation was adopted in February 2013, some seven months later. The German Psychiatric Association, nurses associations, and unions expressed serious concerns. Violent incidents and mechanical coercive interventions, such as seclusion and restraint (defined as bringing a patient into a locked room or using devices such as belts for limiting the free movement of a patient), as well as the duration of treatment, were expected to increase, and patients with less severe states of illness might avoid hospitalization for voluntary psychiatric inpatient treatment because of an antitherapeutic and threatening atmosphere.
The quasi-experimental situation created by the gap in legislation gave us the opportunity to evaluate the impact of a changing legal situation on clinical practice and prospectively investigate whether the concerns voiced about the possibility of an increase in violence and use of mechanical coercive interventions were justified.
New legislation modifying the guardianship law and Baden-Wuerttemberg’s public law took the constitutional court’s decisions into account. Accordingly, coercive medication is again possible under strict conditions. After a patient is involuntarily committed, an additional decision by a court is required to institute involuntary treatment, based on a review by a psychiatrist who is not involved in the patient’s treatment. Coercive medication can be allowed only if the patient lacks capacity to consent, if there is a severe danger to the patient’s or others’ health or life, if expected benefits outweigh adverse effects of the proposed treatment, and if considerable efforts to persuade the patient have failed.
The new legislation in 2013 made involuntary medication under stricter requirements possible again, allowing us to examine whether changes observed in the number of violent incidents and the use of mechanical restraints were only temporary. For this purpose, we analyzed the common routine documentation of seven psychiatric hospitals with separate catchment areas. We focused on patients with psychotic and bipolar disorders because they are predominantly affected by involuntary medication. We asked the following questions: Did the number and severity of violent incidents increase? Did use of seclusion and restraint increase in terms of absolute numbers, duration, and percentage of patients affected? Were there changes in mean length of hospitalization and severity of illness at admission?
An association between these outcomes and changes in the legislation would be considered probable if the observed changes vanished after adoption of the new legislation.
Methods
Psychiatric Hospitals
The Centers for Psychiatry Suedwuerttemberg provide psychiatric inpatient and outpatient treatment at seven sites, serving a catchment area of approximately 1.2 million inhabitants in southwest Germany. No other psychiatric hospitals exist in the region. Treatment guidelines are in line with the German Psychiatric Association’s guidelines for treatment of schizophrenia (5) and bipolar disorder (6). Use of seclusion and restraint is regulated in all hospitals by a common guideline that is in accordance with the guideline of the German Psychiatric Association (7). Seclusion and restraint interventions may be used only as a last resort by trained staff if all efforts to achieve deescalation have failed and must be mandated by a doctor. A decision to use either restraint or seclusion is made by the responsible doctor according to clinical necessities, but patient preferences regarding use of one or another measure must be taken into account. Staffing levels are comparable in all hospitals. The electronic patient records in all seven hospitals contain identical routine data as well as standardized forms for the documentation of coercive interventions, violent incidents, and severity of illness. Because of legal obligations to collect this information, these records, particularly the data on coercive measures, are considered highly accurate (8,9). The electronic data in general have been found to be sufficiently valid and reliable (10).
Database
We conducted a cross-sectional analysis of case-related routine data from the seven psychiatric hospitals in three time periods (period 1, July 2011–February 2012; period 2, July 2012–February 2013; and period 3, July 2013–February 2014). Cases were defined as episodes of inpatient treatment. Involuntary medication was legally permitted in periods 1 and 3 but was unlawful in period 2. The ban comprised all use of medication against a patient's will, except for cases of emergency.
Inclusion Criteria
We included all patients with a primary diagnosis of schizophrenic (F2x [ICD-10 code]) or manic (F30.x, F31.0–F31.2, F31.6) disorder who had been hospitalized during at least one of the three time periods. We included those diagnostic groups because they are predominantly affected by involuntary medication (11). Patients with a secondary diagnosis of an organic disorder, including symptomatic mental disorders (F0x) or mental retardation (F7x) were excluded.
Assessment of Outcomes and Instruments
Outcomes were the number and duration of coercive measures, the number and the severity of violent incidents by patients, the length of hospitalization, and the severity of illness at admission.
The number and duration of coercive measures and the length of hospitalization were extracted from the database. Coercive measures are ordered by doctors. The exact beginning and end are documented in the electronic patient record by nursing staff and thus are available for analyses. Involuntary medication was not accurately recorded in period 1, given that there was neither a legal obligation to record nor a clear legal definition of involuntary medication at that time. Thus data on the frequency of involuntary medication according to guardianship law or civil law during period 1 were not available.
Sociodemographic and clinical data were routinely recorded by a validated adaptation of the German clinical basic documentation (10,12). Violent incidents by patients were assessed by using the Staff Observation of Aggression Scale–Revised (SOAS-R) (13). The SOAS-R is an incident-based instrument for documenting and rating the nature and severity of violent incidents involving inpatients. Scores range from 0 to 22, with higher scores indicating greater severity of aggression. Severity of illness at admission was assessed by using the Clinical Global Impression severity of illness rating (CGI-S) (14). The CGI-S rates the severity of illness relative to all patients with the same diagnosis on a 7-point scale ranging from 1, “normal, not ill at all,” to 7, “extremely ill.”
Definitions
All cases with court decisions approving involuntary commitment were classified as involuntary admission. Cases in which patients had been involuntarily admitted but changed their minds within a period of three days and subsequently stayed on a voluntary basis were also classified as involuntary.
Seclusion is defined as bringing a patient to a locked room from which she or he is unable to leave but in which she or he is able to move freely. During seclusion, patients are observed through a door window or by video monitoring.
Restraint is defined as the use of belts to fix a patient to a bed. According to the internal hospital guidelines, patients must be constantly and personally monitored during restraint (1:1 supervision).
Involuntary medication is the use of any medication, oral or per injection, against a patient's explicit or implicit will. Medication is also classified as involuntary if patients consent to it in order to avoid otherwise being subjected to a different kind of coercive measure. There are two types of involuntary medication—medication in cases of acute emergency to prevent serious harm and involuntary medication after a judge’s decision based on an independent expert’s review. The latter form of involuntary medication can occur as a matter of guardianship law as well as a matter of public law.
Statistical Analysis
Differences between the sociodemographic variables of the samples in the three time periods were assessed with t tests for age and chi-square tests for involuntary admission, age, gender, marital status (married or living in partnership), migration background, native language (German or other), regular employment, and residence in assisted or sheltered living.
To assess differences between outcomes for the various time periods, separate generalized linear models for each outcome were fitted. Outcomes were the proportion of cases exposed to any seclusion or restraint intervention, to restraint, to seclusion, or to emergency medication; the proportion of restraint cases with 1:1 monitoring; the proportion of cases with violent incidents; the number and the duration of seclusion and restraint interventions; the number and severity of violent incidents; length of stay; and severity of illness at admission. For the number of seclusion and restraint interventions and the number of violent incidents, Poisson models with length of hospitalization as an exposure variable were fitted. For the proportion of seclusion and restraint cases, emergency medication cases, cases with 1:1 monitoring, and cases with violent incidents, logistic models were fitted. All estimations were done using the bootstrap method. The three time periods were compared pairwise (period 1 vs. period 2, period 2 vs. period 3, and period 1 vs. period 3).
To detect possible confounders, associations were assessed between length of hospitalization, involuntary admission, age, gender, marital status, migration background, native language, regular employment, and residence in assisted or sheltered living and the outcomes by using Spearman's rho correlations. Variables that differed significantly between time periods or that were significantly associated with one of the outcomes were included in the analyses as covariates.
Results
In total, we included 2,071 patients (N=1,004 women, 49%) with 3,482 episodes of inpatient treatment (cases). The mean±SD age was 47.2±15.8 years. Most patients (N=1,919, 93%) had a diagnosis of schizophrenia, 378 (20% of 1,935 patients with data) had a migration background, 339 (17% of 1,959 patients with data) had a first language other than German, 457 (25% of 1,851 patients with data) were married or living in a partnership, 401 (23% of 1,780 patients with data) were in regular employment, and 651 (34% of 1,934 patients with data) were living in assisted or sheltered conditions.
The proportion of patients with involuntary admissions and the proportion of patients living in a partnership differed significantly between periods 1 and 2 (Table 1). The proportion of women, the proportion of patients living in a partnership, and the proportion of patients living in assisted or sheltered conditions differed significantly between periods 2 and 3. The samples of patients in periods 1 and 3 did not differ significantly.
| Period 1 (N=1,194) | Period 2 (N=1,147) | Period 3 (N=1,141) | ||||
|---|---|---|---|---|---|---|
| Characteristic | N | % | N | % | N | % |
| Age (M±SD) | 44.6±15.5 | 46.6±14.7 | 46.4±15.0 | |||
| Women | 547 | 46 | 506 | 44b* | 562 | 49b* |
| Involuntary admission | 188 | 16b* | 152 | 13b* | 153 | 13 |
| Diagnosis of schizophrenia | 1,118 | 94 | 1,074 | 94 | 1,064 | 94 |
| Married or living in partnership | 235 | 23b** | 157 | 18b**,c*** | 229 | 24c*** |
| Migration background | 212 | 20 | 178 | 18 | 185 | 19 |
| German as native language | 890 | 82 | 836 | 83 | 848 | 83 |
| Regular employment | 177 | 19 | 179 | 20 | 165 | 19 |
| Assisted or sheltered living | 403 | 38 | 332 | 34b* | 405 | 41b* |
a
Period 1, July 2011–February 2012; period 2, July 2012–February 2013; and period 3, July 2013–February 2014. Ns reflect total number of episodes of inpatient treatment (N=3,482).
b,c
Values sharing the same footnote letter are significantly different
*
p<.05, **p<.01, ***p<.001
The samples did not differ in the proportion of cases affected by any seclusion or restraint intervention. There was also no difference between samples in the proportion of cases affected by restraint, in the proportion of cases affected by emergency medication, and in the proportion of cases with 1:1 monitoring. The samples of period 1 and period 2 and the samples of period 1 and period 3 differed significantly in the proportion of cases affected by seclusion (Table 2). Data on involuntary medication after a judge’s decision were available only for period 3, during which six cases (1%) were affected.
| Period 1 | Period 2 | Period 3 | |
|---|---|---|---|
| Outcome | (N=1,194) | (N=1,147) | (N=1,141) |
| Total N of SR interventions | 686 | 838 | 624 |
| N of SR interventions per case (M±SD) | .57±3.68b,c,d*** | .73±3.14b,c*** | .55±2.52c,d*** |
| Duration of SR intervention (M±SD hours) | 4.4±37.5 | 4.1±18.4 | 4.8±29.9 |
| Total N of restraint interventions | 398 | 298 | 150 |
| N of restraint interventions per case (M±SD) | .33±2.93b,d*** | .26±1.30b,c*** | .13±.84c,d*** |
| Total N of seclusion interventions | 288 | 540 | 474 |
| N of seclusion interventions per case (M±SD) | .24±1.38b,d*** | .47±2.02b,c*** | .42±2.09c,d*** |
| Total N of violent incidents | 297 | 346 | 265 |
| N of violent incidents per case (M±SD) | .25±1.71b,d*** | .30±1.14b***,c* | .23±1.13c*,d*** |
| SOAS-R score per case (M±SD)e | 2.7±15.6 | 3.2±12.6 | 2.7±13.5 |
| CGI-S score per case (M±SD)f | 4.3±.8 | 4.3±.8 | 4.3±.8 |
| Length of hospitalization (M±SD days) | 29.0±28.1 | 27.8±25.5 | 28.4±26.1 |
a
Cases are defined as episodes of inpatient treatment.
b,c,d
Values sharing the same footnote letter are significantly different.
e
SOAS-R, Staff Observation of Aggression Scale–Revised. Scores range from 0 to 22, with higher scores indicating greater severity of aggression.
f
The Clinical Global Impression severity of illness rating (CGI-S) rates the severity of illness on a 7-point scale ranging from 1, “normal, not ill at all,” to 7, “extremely ill.”
*
p<.05, ***p<.001
The absolute number of seclusion or restraint interventions and the absolute number of violent incidents were higher for period 2, when involuntary medication was unlawful, compared with periods 1 and 3, when involuntary medication was possible. The absolute number of seclusion or restraint interventions in period 2 (N=838) was 22% higher compared with period 1 (N=686) and 34% higher compared with period 3 (N=624). The absolute number of violent incidents in period 2 (N=346) was 16% higher compared with period 1 (N=297) and 31% higher compared with period 3 (N=265).
After the analyses adjusted for possible confounders, we found significant differences between period 2 and one or both of the other time periods in the mean number of seclusion and restraint interventions per case (Table 2), the mean number of seclusion or restraint interventions in cases involving those interventions (affected cases) (Table 3), the mean number of violent incidents per case (Table 2), and the mean number of violent incidents per affected case (Table 4). There were 28% more seclusion and restraint incidents per case (Table 2), 27% more seclusion and restraint incidents per affected case (Table 3), 20% more violent incidents per case, and 9% more violent incidents per affected case (Table 4) in period 2 compared with period 1. There were 33% more seclusion and restraint incidents per case (Table 2), 27% more seclusion and restraint incidents per affected case (Table 3), and 30% more violent incidents per case (Table 2) in period 2 compared with period 3. We also found significant differences in seclusion and restraint incidents and in violent incidents between the periods in which involuntary medication was permitted (Table 2).
| Period 1 (N=1,194) | Period 2 (N=1,147) | Period 3 (N=1,141) | ||||
|---|---|---|---|---|---|---|
| Outcome | N | % | N | % | N | % |
| Seclusion or restraint (SR) | 168 | 14 | 162 | 14 | 152 | 13 |
| Restraint | 119 | 10 | 99 | 9 | 65 | 6 |
| Seclusion | 86 | 7b*,c** | 121 | 11b* | 101 | 9c** |
| Emergency medication | 34 | 3 | 23 | 2 | 24 | 2 |
| 1:1 monitoringd | 167 | 14 | 171 | 15 | 177 | 16 |
| SR interventions per affected case (M±SD)e | 4.1±9.1b*** | 5.2±6.9b,c*** | 4.1±5.8c*** | |||
| Cumulative duration of SR interventions per affected case (M±SD hours)e | 31.3±95.9 | 29.3±40.9 | 30.3±73.8 | |||
| Restraint interventions per affected case (M±SD)g | 3.34±8.87b**,f*** | 3.01±3.39b**,c*** | 2.31±2.74c,f*** | |||
| Seclusion interventions per affected case (M±SD)h | 3.4±4.0b*** | 5.4±6.5b***,c* | 3.9±5.3c* | |||
a
Cases are defined as episodes of inpatient treatment.
b,c,f
Values sharing the same footnote letter are significantly different.
d
Internal hospital guidelines require that patients must be constantly and personally monitored during restraint.
e
An affected case is an episode of inpatient treatment involving SR.
g
An affected case is an episode of inpatient treatment involving restraint.
h
An affected case is an episode of inpatient treatment involving seclusion.
*
p<.05, **p<.01, ***p<.001
| Period 1 (N=1,194) | Period 2 (N=1,147) | Period 3 (N=1,141) | ||||
|---|---|---|---|---|---|---|
| Variable | N | % | N | % | N | % |
| All violent incidents | 297 | 346 | 265 | |||
| Cases involving violent incidents | 137 | 11 | 147 | 13b* | 115 | 10b* |
| Violent incidents per affected case (M±SD)d | 2.2±4.6b,c*** | 2.4±2.3b*** | 2.3±3.4c*** | |||
| SOAS-R score per violent incident (M±SD)e | 11.0±5.4 | 11.0±4.8 | 11.2±5.0 | |||
a
Cases are defined as episodes of inpatient treatment.
b,c
Values sharing the same footnote letter are significantly different.
d
An affected case is an episode of inpatient treatment involving a violent incident.
e
SOAS-R, Staff Observation of Aggression Scale–Revised. Scores range from 0 to 22, with higher scores indicating greater severity of aggression.
*
p<.05, ***p<.001
Discussion
We examined whether number and duration of seclusion and restraint interventions, number and severity of violent incidents, and clinical outcomes changed in a period during which involuntary medication of detained psychiatric inpatients was unlawful. The number of seclusion and restraint interventions and of violent incidents increased substantially among patients with psychotic disorders, whereas the percentage of patients subjected to seclusion and restraint interventions and the percentage of patients who caused violent incidents as well as the mean severity of violent incidents remained roughly constant. This means that the ban on involuntary medication had no consequences for the majority of patients who took their medication more or less voluntarily.
Approximately six out of seven patients with psychotic disorders were not subjected to any further coercive interventions, even if involuntarily committed. However, for the small portion of patients subjected to coercive measures, the impossibility of involuntary medication led to a significant increase in seclusion and restraint interventions. The causal relationship is confirmed by the finding that the total amount of coercive measures decreased in period 3 to the same level as for period 1, before the ban on involuntary medication. Other changes of policy that could have affected use of seclusion and restraint were not implemented during this period. The guidelines for use of seclusion and restraint did not change between periods, nor did the required documentation. However, it is striking that the number of patients who were subjected to seclusion during the period without coercive medication increased relatively more compared with the number of patients who were subjected to restraint and that this tendency continued after new legislation came into effect permitting use of coercive medication. Effectively, recurrent episodes of coercive measures were used in lieu of coercive medication to address limit-testing behaviors among patients with manic disorders, and seclusion seemed to be considered more appropriate than physical restraint as a short time-out in those situations. This practice is reflected by a shorter mean duration of seclusion and restraint interventions in period 2. The experience with this kind of intervention led to a shift from the use of restraint to the use of seclusion, according to our previous findings that patients suffered less psychological distress from seclusion than from restraint (15).
Although the number of seclusion and restraint incidents increased without use of involuntary medication, the cumulative duration of seclusion and restraint per affected case remained roughly constant across all three periods. Thus seclusion and restraint interventions were applied more frequently but for shorter periods of time. In clinical practice at that time, as reported in many conference contributions in Germany, nursing staff felt a greater burden by continuously difficult-to-manage patients, but they tried to keep episodes of seclusion and restraint, frequently caused by violent patients in manic or acutely psychotic states, as short as possible.
This quasi-experimental observational study adds further evidence concerning the question of whether abolishing or banning a coercive measure is simply futile, if in fact the measure is compensated for by another equally coercive measure, or a sign of progress. Only recently, the United Nations rapporteur on torture and other inhuman, cruel, or degrading treatment called coercive treatment in psychiatry an abusive practice and ill treatment, calling for an absolute ban of such measures (16). Our findings support the assumption that a ban on involuntary medication leads to undesired consequences, including not only an increase in seclusion and restraint but also an increase in violent incidents and a probable negative impact on ward atmosphere. These changes cannot be considered an improvement for inpatients with a mental illness. These findings are in line with some recent studies in the Netherlands, where a strong restriction on involuntary medication has led to an extensive use of seclusion compared with similar countries (3,17). A randomized controlled trial provided evidence that the use of seclusion could be reduced by half if medication was the first choice in situations in which the use of coercion seemed necessary (18). Another report found that involuntary medication was associated with less subjective distress compared with seclusion and restraint (19). On the other hand, a $32-million, nationwide Dutch program to reduce seclusion achieved its goal to a considerable extent without causing increased use of involuntary medication (20).
Our study had some limitations. First, there is no nationwide registry of coercive measures in Germany. Therefore, the extent to which the data from these seven hospitals are representative of all German psychiatric hospitals, especially those in metropolitan areas, is unclear. Second, we do not know how much involuntary medication was really used in period 1, before its use was subjected to detailed legal regulations. There is evidence that involuntary medication, according to the legal definitions, is now used for only one of approximately 25 inpatients with psychotic disorders (11). This seems to be sufficient to reduce seclusion and restraint and violent incidents to the level that existed prior to legal regulation.
Another limitation was that the patients' perspective was not considered. We had no data available on patients' preferences for an intervention during times of distress. Such data, however, would have been useful for the interpretation of the results.
Conclusions
Restriction of involuntary medication was associated with a significant increase in mechanical coercive measures and violent incidents. Coercive medication is a severe violation of a patient’s autonomy and should be used only under very strict conditions. Further evidence is necessary to support ethical decision making concerning the use of coercion.
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Cover: pocket watch, by Robert et Courvoisier, 1800–1816. Silver, brass, ormuolu, enamel, and steel. Bequest of Henry Francis du Pont, Winterthur Museum, Winterthur, Del.
History
Received: 6 November 2015
Revision received: 3 March 2016
Accepted: 12 April 2016
Published online: 1 August 2016
Published in print: December 01, 2016
Keywords
Authors
Funding Information
Dr. Flammer reports no financial relationships with commercial interests. Dr. Steinert receives funding from the German Psychiatric Association for development of a guideline on aggressive behavior and from the German Ministry of Health for future research on coercive interventions.
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