Interprofessional evidence-based counselling programme for complementary and integrative healthcare in patients with cancer: study protocol for the controlled implementation study CCC-Integrativ.

INTRODUCTION: According to international literature, patients with cancer wish to have information on complementary and integrative healthcare (CIH). Medical guidelines recommend actively approaching patients with cancer discussing potential benefits and risks of individual CIH methods. While some CIH methods, for example, acupuncture and yoga, have been proven effective in high-quality studies, other CIH methods lack studies or bear the risk of interactions with chemotherapeutics, for example, herbal drugs. Therefore, an evidence-based interprofessional counselling programme on CIH will be implemented at four Comprehensive Cancer Centres in the federal state of Baden-Wuerttemberg, Germany. METHODS AND ANALYSIS: A complex intervention consisting of elements on patient, provider and system levels will be developed and evaluated within a multilayer evaluation design with confirmatory evaluation on patient level. Patients with a cancer diagnosis within the last 6 months will receive three individual counselling sessions on CIH within 3 months (=intervention on patient level). The counselling will be provided by an interprofessional team of medical and nursing staff. For this purpose, an intensive online training programme, a CIH knowledge database and an interprofessional team-building process were developed and implemented (=intervention on provider level). Moreover, training events on the basics of CIH are offered in the outpatient setting (=intervention on system level). Primary outcome of the evaluation at the patient level is patient activation measured (PAM) with the PAM-13 after 3 months. Secondary outcomes, for example, quality of life, self-efficacy and clinical parameters, will be assessed at baseline, after 3 months and at 6 months follow-up. The intervention group (n=1000) will be compared with a control group (n=500, treatment as usual, no CIH counselling. The outcomes and follow-up times in the control group are the same as in the intervention group. Moreover, the use of health services will be analysed in both groups using routine data. A qualitative-quantitative process evaluation as well as a health economic evaluation will identify relevant barriers and enabling factors for later roll-out. ETHICS AND DISSEMINATION: The study has been approved by the appropriate Institutional Ethical Committee of the University of Tuebingen, No. 658/2019BO1. The results of these studies will be disseminated to academic audiences and in the community. TRIAL REGISTRATION NUMBER: DRKS00021779; Pre-results.

Reliability of Paper-Based Routine Documentation in Psychiatric Inpatient Care and Recommendations for Further Improvement.

Background: Health services research is of increasing importance in current psychiatry. Therefore, large datasets and aggregation of data generated by electronic routine documentation due to legal, financial, or administrative purposes play an important role. However, paper-based routine documentation is still of interest. It remains relevant in less developed health care systems, in emergency settings, and in long-term retrospective and historical studies. Whereas studies examining the reliability of electronic routine documentation support the application of routine data for research purposes, our knowledge regarding reliability of paper-based routine documentation is still very sparse. Methods: Basic documentation (BADO) was completed on paper forms and digitalized manually for all inpatients of the Department of Psychiatry and Psychotherapy, University Hospital Hamburg-Eppendorf, Germany, treated within the time period from 1998 to 2006. Four hundred twelve cases of first-episode psychosis patients were chosen for comparison with clinical data from paper-based patient files. The percentage of missing information, the percentage of correct classifications, sensitivity, and positive predictive value were calculated for all applicable variables. Results: In eight cases (1.9%), a BADO form was available, but was not filled in. In 37 cases (7.0%), the patient files were lost and could not be obtained from the centralized archive. Routine data were available for all other cases in 20 (58.8%) of the examined 34 variables, and the percentage of missing data for the remaining variables ranged between 0.3% and 22.9%, with only the variables education and suicidality during treatment having more than 5% missing data. In general, the overall rate of correct classifications was high, with a median percentage of 86.4% to 99.7% for the examined variables. Sensitivity was above 75% for eight and <75% but above 50% for six of the examined 17 variables. Values for the positive predictive value were above 75% for nine and <75% but above 50% for three variables. Conclusion: In summary, paper-based routine documentation reaches acceptable reliability, but this is dependent on the chosen documentation categories and variables. Based on the present findings, paper-based routine documentation can indeed be used for quality management, organizational development, and health services research. Its limitations, however, have to be kept in mind.

Positive Effects of an Anti-Aggression and De-Escalation Training on Ward Atmosphere and Subjective Safety May Depend on Previous Training Experience.

Anti-aggression and de-escalation (ADE) trainings of health-care professionals working on psychiatric inpatient wards have been shown to increase staff knowledge and confidence, which could be connected with higher subjective safety. Additionally, a potential reduction of aggressive incidents could improve ward atmosphere. Thus, the current study aimed to investigate the effects of ADE training on ward atmosphere and subjective safety. In 2015, an ADE training was established at the Psychiatric University Clinics (UPK), University of Basel. Nursing staff from 22 wards received theoretical and practical training over the course of 5 days. Ward atmosphere and subjective safety were assessed using the Essen Climate Evaluation Schema (EssenCES). A total of 46 people had been assessed in 2012 before training implementation (baseline), and 45 persons in 2016 after implementation. In the 2016 group, 23 people had previously participated in an ADE training, and 22 were first-time participants. Patients' coherence (p = 0.004), subjective safety (p = 0.004), and ward atmosphere (p = 0.001) were rated significantly higher by first-time ADE training participants compared to baseline, and patients' coherence (p = 0.029) and ward atmosphere (p = 0.011) were rated significantly higher by first-time ADE training participants than by nurses with prior ADE training. There were no significant differences regarding any EssenCES ratings by nurses with prior ADE training compared to baseline. ADE training was exclusively connected with higher ratings on most EssenCES scales for first-time participants. This indicates that the positive effects of ADE training may depend on previous training experience.

Aggression and violence in psychiatric hospitals with and without open door policies: A 15-year naturalistic observational study.

Aggressive behavior and violence in psychiatric patients have often been quoted to justify more restrictive settings in psychiatric facilities. However, the effects of open vs. locked door policies on aggressive incidents remain unclear. This study had a naturalistic observational design and analyzed the occurrence of aggressive behavior as well as the use of seclusion or restraint in 21 German hospitals. The analysis included data from 1998 to 2012 and contained a total of n = 314,330 cases, either treated in one of 17 hospitals with (n = 68,135) or in one of 4 hospitals without an open door policy (n = 246,195). We also analyzed the data according to participants' stay on open, partially open, or locked wards. To compare hospital and ward types, we used generalized linear mixed-effects models on a propensity score matched subset (n = 126,268) and on the total dataset. The effect of open vs. locked door policy was non-significant in all analyses of aggressive behavior during treatment. Restraint or seclusion during treatment was less likely in hospitals with an open door policy. On open wards, any aggressive behavior and restraint or seclusion were less likely, whereas bodily harm was more likely than on closed wards. Hospitals with open door policies did not differ from hospitals with locked wards regarding different forms of aggression. Other restrictive interventions used to control aggression were significantly reduced in open settings. Open wards seem to have a positive effect on reducing aggression. Future research should focus on mental health care policies targeted at empowering treatment approaches, respecting the patient's autonomy and promoting reductions of institutional coercion.

Modulation of HPA axis response to social stress in schizophrenia by childhood trauma.

HPA axis functioning plays an important role in the etiology of schizophrenia spectrum disorders (SSD). However, only few studies have examined HPA axis responsivity to psychosocial stress in SSD, and results are heterogeneous. Furthermore, childhood trauma is known to influence psychopathology and treatment outcome in SSD, but studies on the influence of childhood trauma on stress related HPA axis activity are missing. The purpose of this study was to investigate cortisol response to a psychosocial stress challenge in SSD patients, and to examine its association with severity of childhood trauma. The present study included 25 subacutely ill patients with a current episode of a chronic SSD and 25 healthy controls. Participants underwent the modified Trier Social Stress Test, and salivary cortisol levels were assessed. The childhood trauma questionnaire was used to assess severity of adverse life events. Overall, cortisol response was blunted in the patient group compared to the control group (p<0.01). Furthermore, we identified two patient subgroups (cortisol responders (n=12) vs. non-responders (n=13) to the modified TSST) that differed in their severity of childhood trauma experience: responders had experienced more emotional abuse in their past (p<0.042). Therefore, childhood trauma might influence stress-related HPA axis activity in SSD. Our data contribute to the hypothesis that severity of childhood trauma may be of pathophysiological relevance in schizophrenia. In addition, it may be an overlooked factor contributing to inconsistent findings regarding HPA axis response to psychosocial stress in SSD.

Suicide risk and absconding in psychiatric hospitals with and without open door policies: a 15 year, observational study.

BACKGROUND: Inpatient suicide and absconding of inpatients at risk of self-endangering behaviour are important challenges for all medical disciplines, particularly psychiatry. Patients at risk are often admitted to locked wards in psychiatric hospitals to prevent absconding, suicide attempts, and death by suicide. However, there is insufficient evidence that treatment on locked wards can effectively prevent these outcomes. We did this study to compare hospitals without locked wards and hospitals with locked wards and to establish whether hospital type has an effect on these outcomes. METHODS: In this 15 year, naturalistic observational study, we examined 349 574 admissions to 21 German psychiatric inpatient hospitals from Jan 1, 1998, to Dec 31, 2012. We used propensity score matching to select 145 738 cases for an analysis, which allowed for causal inference on the effect of ward type (ie, locked, partly locked, open, and day clinic wards) and hospital type (ie, hospitals with and without locked wards) on suicide, suicide attempts, and absconding (with and without return), despite the absence of an experimental design. We used generalised linear mixed-effects models to analyse the data. FINDINGS: In the 145 738 propensity score-matched cases, suicide (OR 1·326, 95% CI 0·803-2·113; p=0·24), suicide attempts (1·057, 0·787-1·412; p=0·71), and absconding with return (1·288, 0·874-1·929; p=0·21) and without return (1·090, 0·722-1·659; p=0·69) were not increased in hospitals with an open door policy. Compared with treatment on locked wards, treatment on open wards was associated with a decreased probability of suicide attempts (OR 0·658, 95% CI 0·504-0·864; p=0·003), absconding with return (0·629, 0·524-0·764; p<0·0001), and absconding without return (0·707, 0·546-0·925; p=0·01), but not completed suicide (0·823, 0·376-1·766; p=0·63). INTERPRETATION: Locked doors might not be able to prevent suicide and absconding. FUNDING: None.