Original article
Joint Crisis Plans and Crisis Cards in Inpatient Psychiatric Treatment
A Multicenter Randomized Controlled Trial
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Background: Joint Crisis Plans (JCP) and crisis cards (CC) are both instruments designed to improve the management of future psychiatric crisis situations, but they differ, for example, in terms of resource use, legal validity, and aims. International research findings for JCP are inconsistent.
Methods: From January 2018 to December 2020, a single-blinded, two-armed multicenter RCT was carried out, with assessments at T0 (baseline) and T1 (18 months later). The patients included had schizophrenia or schizoaffective disorder and were aged between 18 and 62 years. The primary outcome was the cumulative duration of inpatient treatment (voluntary/involuntary), and coercive measures comprised the secondary outcome. Trial registration: DRKS00013985.
Results: Of the 266 study participants, 157 completed the study. In the CC group 57.8% and in the JCP group 64.9% were admitted to psychiatric hospitals between the index treatment and T1 (p = 0.367); 8.4% of the CC group and 12.2% of the JPC group were admitted against their will (p = 0.441). The cumulative treatment duration was not significantly shorter (p = 0.631) in the JPC group (mean 42.43 days, SD = 48.60) than in the CC group (50.16 days, SD = 74.16). Thus, JPCs did not achieve the expected improvement with regard to the primary endpoint. There were also no relevant differences regarding the secondary endpoint. Major effects in favor of the JCP were observed, however, in patients’ development of conficence in the treatment teams and in their active participation in the treatment procedure.
Conclusion: Although the study showed no superiority of JCP over CC with regard to the primary and secondary outcomes, JCP should be used more frequently in routine practice as an intervention to support a participative approach to treatment.
Human autonomy has become a widely discussed topic in societal discourse in recent decades, and its protection is mandated not just by the laws of individual countries, but also by international agreements such as the Ottawa Charter and the UN Convention on the Rights of Persons with Disabilities (UN CRPD). A number of tools have been developed to help physicians fulfill this high ethical and legal requirement in acutely ill patients, in both the somatic (e.g., living wills) and psychiatric treatment settings. For prospective health-care planning in the mental health context, the term “psychiatric advance directive” (1) is used in the international literature; according to Scholten et al. (2), the use of this term is recommended by the UN CRPD Committee.
Advance directives, like living wills and psychiatric wills, can be issued unilaterally, i.e., by the patient alone, or bilaterally as a contractual arrangement between the patient and the treatment team (1). One form of bilateral advance directive is the treatment agreement called the Joint Crisis Plan, JCP) (3), which was developed in Bielefeld with the participation of mental health care professionals, patients, and family members and first implemented throughout Germany in 1994 (4, 5). A JCP consists of an agreement that is equivalent to a legally binding living will, along with further agreements that the hospital commits itself to implement (4, 6). The crisis passport (CP) or crisis card (CC) (7) has also become established as a tool for planning in advance of crisis situations: it contains information on what should be done in such situations in pocket format (e.g., contact details of trusted persons, treatment providers, medications) (1).
Although it has been almost three decades since the signing of the very first JCP, a survey across Germany in 2009 revealed that only 8% of inpatient psychiatric services offered them routinely to all patients, while 77% limited their use to a specific group of patients” (8). There were also regional differences in the use of JCPs, which was more common in the western part of the country than in the south or the northeast (8). More recent data are not available; however, Borbé et al., writing in 2012, expressed confidence that the legal clarification provided in Germany by the Living Wills Act, which came into effect in 2009, would increase the use of JCPs. Since the survey of 2009, JCPs have also been incorporated into the laws of some of the German federal states (for example, the Mental Illness Law in North Rhine—Westphalia) and have been recommended in S3 guidelines, either on a diagnosis-specific basis (S3 guideline on schizophrenia) (9) or across diagnoses (S3 guideline on the limitation of coercive measures) (10). Nevertheless, JCPs do not yet seem to be routinely offered at all sites. As recommended by Steinert and Hirsch (11), advise the completion of at least 10 JCPs or CPs per 1000 discharges. In the S3 guideline, JCPs and CPs/CCs are listed with recommendation grade A, but only evidence level 2, as the recommendation is based on a strong consensus among experts as well as a marked preference among patients (10).
In the largest randomized and controlled trial to date, the CRIMSON trial (United Kingdom), JCPs were shown to have a significant positive effect on certain aspects of the therapeutic relationship, but not on the number of involuntary commitments to a psychiatric service or on the duration of each such hospitalization in days (12,13). This contrasts with, e.g., the finding of Henderson et al. (14) that JCPs significantly lowered both of these. Lequin et al. (15) found that both patients and professionals consider JCPs a very helpful tool for support and reassurance, with benefits including a better physician-patient relationship, respect for the patient’s wishes, and an increased sense of control over one‘s own illness.
In the S3 guideline (10), the weaker level of evidence (level 2) is accounted for by inconsistencies in the available evidence, and by the lack of any evidence specifically for Germany. The ADiP study (ADiP = Advance Directives in Psychiatry) presented here, which is funded by the state of North Rhine—Westphalia (NRW), is intended to help close this research gap (eBox 1). Its main hypothesis was that JCPs, though more cumbersome than CPs, are more effective in reducing the cumulative inpatient treatment duration (with or without involuntary commitment).
Methods
Design
A single-blind, two-armed, randomized and controlled trial was conducted from January 2018 to December 2020 in five inpatient psychiatric services in NRW: Evangelisches Klinikum Bethel [Universitätsklinikum OWL], LWL-Universitätsklinikum Bochum, LVR-Klinikum Bonn, LWL-Klinikum Marsberg, and Alexius/Josef-Krankenhaus Neuss (eBox 2). The trial was approved by the Ethics Committee of the Ruhr University Bochum (17–6059) and entered in the German Clinical Trials Registry (DRKS00013985) (16).
Trial participants
Subjects were recruited from January 2018 to March 2019. Patients aged 18 to 62 with a clinical diagnosis of schizophrenia or schizoaffective disorder (ICD-10 codes F.20/F.25) (17) were eligible for inclusion. For further information on the inclusion and exclusion criteria, recruitment, and sample size, see eBox 3.
Primary and secondary endpoints
The primary endpoint was the total cumulative duration of inpatient treatment (with or without involuntary commitment), and the secondary endpoint was the frequency of coercive measures (physical restraints, isolation, forced medication). Among the further endpoints of the trial were subjective evaluations of JCP and CC, psychopathology, and the level of overall psychosocial function (18).
Interventions (JCP and CC)
Both of these interventions are designed for advance planning in case of a crisis, and they were introduced and implemented in a standardized manner. They differ in major respects, however, including their respective goals, the time point at which they are generated, their labor-intensiveness, and their legal validity (eBox 4).
Data acquisition
The data were acquired at two standardized time points: T0 = baseline at the time of the patient’s inclusion in the trial, and T1 = 18 months after the index hospitalization. Data acquisition at each of these time points involved an extensive review of treatment data on the basis of documentation by the inpatient psychiatric service, as well as external documents and standardized questionnaires (19, 20, 21, 22) (eBox 5). Despite standardization, there was individual variation in the circumstances of the T1 interview owing to the COVID-19 pandemic.
Data analysis
All of the statistical analyses were performed with SPSS, version 27. The hypotheses regarding the primary endpoint and first secondary endpoint were evaluated by using modified intention-to-treat (ITT) analyses, the other hypotheses by using per protocol (PP) analyses. The analysis of the primary endpoint was confirmatory, that of the secondary endpoints exploratory. Further aspects of the data analysis are described in eBox 6, including the nature of the modified ITT analysis, the manner of dealing with missing values, data normalization, significance levels, and statistical tests.
Results
Trial profile
During the recruitment period, 3823 patients underwent 5373 hospitalizations; 672 patients were eligible for the trial. 406 decided not to participate for various reasons, e.g., reservations about the interventions, randomization, or research in general, the time and effort involved in data acquisition, and lack of interest (Figure). 266 patients were enrolled and randomized in the ADiP study.
Sample characteristics
The characteristics of the two groups (JCP and CC) did not differ in any clinically relevant respect (Table 1). The dropout rates did not differ significantly between groups (JCP 46.0% vs. CC 35.7%; χ2 [1/N = 266] = 2.93, p= 0.087). The only significant difference was in the timing of dropping out of the trial, eitherr at T0 or before the intervention (JCP 23.4% vs. CC 7.8%; χ2 [2/N = 266] = 12.18, p = 0.002), but this effect was small (V = 0.21) Three patients in the JCP group and none in the CC group refused the intervention. The trial dropouts had fewer prior hospitalizations than the subjects who completed the trial regularly, but did not differ from them with respect to their diagnoses, duration of disease, psychopathology, or psychosocial functioning level(eTable). In the 18 months before index treatment, there were no relevant differences in either the number or the duration of prior hospitalizations (voluntary/per involuntary commitment) between subjects of both groups.
Primary endpoint: cumulative duration of treatment
As shown in Table 2, JCP was not found to be superior to CC with respect to the total number of treatments or the number of involuntary commitments. The mean length of stay in the hospital was not shorter in the JCP group, nor was the mean length of stay after involuntary commitment. The same result was found after a more detailed analysis of the involuntary commitments (those based on German state mental health laws [PsychKG] versus federal civil law [BGB]; commitments under BGB must be justified by a major risk to the health of the affected person, without consideration of the interests of others). The JCP thus did not bring about any improvement in the primary endpoint, as it had been hoped to do.
Between the index treatment and T1, 64.9% of patients in the JCP group and 57.8% in the CC group (48 patients in each group) were fully or partly hospitalized at least once (χ² [1/N = 157] = 0.82, p = 0.367), and 12.2% in the JCP group and 8.4% in the CC group were involuntarily committed at least once (χ2 [1/N = 157] = 0.59, p = 0.441). The two groups did not differ significantly with respect to the median interval until the first inpatient readmission, which was 108 days (95% confidence interval [CI]: [36.22; 179.78]) in the JCP group and 147 days in the CC group (95% CI: [65.60; 228.41) (log-rank test: (χ² [1] = 0.024, p = 0.876; Tarone-Ware test: (χ² [1] = 0.141, p = 0.707). As shown in the eFigure, adding the subjects who were not hospitalized (right-censored data) into the analysis did not result in a significant difference in the intergroup comparison (log-rank test: (χ² [1] = 0.970, p = 0.325; Tarone-Ware test: (χ² [1] = 1.019, p = 0.313).
Secondary endpoint: coercive measures
Between the index treatment and T1, 3.8% of trial participants underwent at least one coercive measure (2.7% of the JCP group and 4.8% of the CC group (χ2 [1/N = 157] = 0.48, p = 0.490). Compared to CC, JCP was associated with fewer coercive measures (forced medication, physical restraint, and isolation) and a shorter duration of physical restraint, but with a greater number and cumulative duration of isolations; these differences were not statistically significant (Table 3).
Subjective assessment of the intervention
As shown in Table 4, the trial subjects judged JCP to be better than CC in every item. Significant differences were found with respect to actively participating in treatment decisions (Z = –3.16, p = 0.002), gaining confidence in the treatment team (Z = –3.12, p = 0.002), and positively influencing one‘s own recovery process (Z = –2.00, p = 0.046).
Eight data sets had to be left out of the per-protocol analyses because of protocol errors in the intervention. Moreover, some of the subjects did not the intervention and were thus unable to assess it subjectively; this lowered the number of analyzed data sets to 113 (50 in the JCP group, 63 in the CC group).
Discussion
Primary and secondary endpoints
The trial did not demonstrate the superiority of JCP over CC with respect to the cumulative duration of hospitalization overall, the cumulative duration of hospitalization after involuntary commitment, or the number and duration of coercive measures. These findings are in accordance with those of the CRIMSON trial (12), which did not demonstrate the superiority of JCP over standard treatment with respect to readmission rates, cumulative treatment duration, or coercive measures. Thornicroft et al. (12) discuss this in terms of model fidelity, improved crisis planning in the standard treatment group, and lack of commitment to crisis planning in the JCP group. These factors may have also influenced the results of the ADiP trial. Moreover, the high dropout rate lessened the chance of obtaining statistically significant results. Only 16 subjects were involuntarily committed between the index treatment and T1, and only 6 were treated with coercive measures; as these events were so rare, no generalizable conclusions could be derived from them. The follow-up period of 18 months was short compared to the time over which mental illnesses persist and progress. The rarity of endpoint events may have led to a type II error, i.e., a failure to detect an actually existing superiority of JCP over CC; but the equivalence of the two interventions, or the actual inferiority of JCP, cannot be ruled out either.
Subjective assessment of the intervention
The subjects rated JCP higher than CC with respect to active involvement in the treatment, gaining trust in the treatment team, and positively influencing one‘s own recovery process. This is in accordance with the findings of Lequin et al (15). However, the superiority of JCP should be interpreted cautiously, as the mean values on the five-point Likert scale ranged only from 3.2 to 4.0. Moreover, almost one-quarter (24.2%) of the patients included in the PP analysis could not assess the intervention because they could not remember it, and not all of the existing assessments were complete. The questionnaire has not been adequately validated to date, either, and no quality criteria are available for it apart from its face validity. The strength of the instrument lies in its having been developed with patient participation and that its content overlaps with the findings of Lequin et al. (15).
Strengths and weaknesses
The planned sample size of 260 subjects was achieved, but the 41% dropout rate was more than double the rate assumed in the power calculation. In the JCP group, the dropout rate before the intervention can be explained by the scheduling of the JCP interview outside of the regular treatment, as is usually done. This required an additional effort on the part of the subjects and the treatment team, while CCs were generated during routine procedures. Losses to follow-up were caused by the COVID-19 pandemic as well as by deviations from T1 standardization. These factors may have biased the outcome.
As endpoints could only be calculated from T1 data, the high dropout rate made obtaining statistically significant results rather unlikely. Potential bias due to missing follow-up data was counteracted by a comparison of the baseline characteristics of participants with and without complete data. Selection bias was minimized by randomization, although it should be noted that randomization in blocks of six does not completely prevent selection bias because of the associated predictability. The risk of other biases (e.g., observer bias, detection bias, attrition bias) was minimized by various measures (standardization, blinding, ITT analysis).
Implications for research and clinical practice
An advantage of JCP over CC with respect to the primary endpoint and the first secondary endpoint was not demonstrated. Positive effects were seen in the subjects’ assessment of the intervention, mainly in confidence building and participatory treatment design, features that were among the goals for which the JCP was developed (4, 23). Thus, the additional effort involved in generating a JCP seems justified. Furthermore, patients themselves demand JCPs, regardless of the mixed evidence from clinical trials (10).
Considering these findings, and in view of the obligation to respect patients‘ rights and autonomy in psychiatric treatment just as in other settings, the authors are of the opinion that JCPs should continue to be offered. It is to be hoped that the S3 guideline (10) and the associated PreVCo study (24) will bring JCPs into more widespread use.
Acknowledgments
We would like to thank Prof. Dr. T. May for the sample size determination and power analysis. We would also like to thank Prof. Dr. Wienke from the Institute of Medical Epidemiology, Biometry and Informatics of the Martin-Luther-Universität Halle-Wittenberg for statistical advice and Prof. Dr. Michael Schulz for his advice and support. We would especially like to thank all of the trial participants for their time and willingness to take part, without which this study would not have been possible.
Data sharing
The authors will be glad to make data available on request.
Conflict of interest statement
Prof. Driessen is a member of the board of directors of the DGPPN.
The other authors state that they have no conflict of interest.
Manuscript received on 12 April 2022, revised version accepted on
17 November 2022.
Translated from the original German by Ethan Taub, M.D.
Corresponding author
Prof. Dr. med. Martin Driessen
Evangelisches Klinikum Bethel
Universitätsklinikum OWL der Universität Bielefeld
Remterweg 69–71, 33617 Bielefeld,Germany
Martin.Driessen@evkb.de
Cite this as:
Rixe J, Neumann E, Möller J, Macdonald L, Wrona E, Bender S, Schormann M, Juckel G, Driessen M: Joint crisis plans and crisis cards in inpatient psychiatric treatment—a multicenter randomized controlled trial. Dtsch Arztebl Int 2023; 120: 125–32. DOI: 10.3238/arztebl.m2022.0384
►Supplementary material
eTable, eFigure, eBoxes:
www.aerzteblatt-international.de/m2022.0384
*2These authors are all last authors.
Evangelisches Klinikum Bethel, University Medical Center East Westphalia-Lippe of University Bielefeld: Jacqueline Rixe, M.Sc., Lina Macdonald, M.Sc., Prof. Dr. med. Martin Driessen
LWL University Hospital Bochum: Dr. phil. Eva Neumann, Prof. Dr. med. Georg Juckel
LVR-Hospital Bonn: Julia Möller, M.Sc., Dr. med. Michael Schormann
Alexius/Josef-Hospital Neuss: Elisa Wrona, M.Sc.
LWL-Hospital Marsberg: PD Dr. med. Stefan Bender, M.Sc.
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