Evaluating a multimodal, clinical and work-directed intervention (RTW-PIA) to support sustainable return to work among employees with mental disorders: study protocol of a multicentre, randomised controlled trial.

BACKGROUND: Mental disorders (MDs) are one of the leading causes for workforce sickness absence and disability worldwide. The burden, costs and challenges are enormous for the individuals concerned, employers and society at large. Although most MDs are characterised by a high risk of relapse after treatment or by chronic courses, interventions that link medical-psychotherapeutic approaches with work-directed components to facilitate a sustainable return to work (RTW) are rare. This protocol describes the design of a study to evaluate the (cost-)effectiveness and implementation process of a multimodal, clinical and work-directed intervention, called RTW-PIA, aimed at employees with MDs to achieve sustainable RTW in Germany. METHODS: The study consists of an effectiveness, a health-economic and a process evaluation, designed as a two-armed, multicentre, randomised controlled trial, conducted in German psychiatric outpatient clinics. Sick-listed employees with MDs will receive either the 18-month RTW-PIA treatment in conjunction with care as usual, or care as usual only. RTW-PIA consists of a face-to-face individual RTW support, RTW aftercare group meetings, and web-based aftercare. Assessments will be conducted at baseline and 6, 12, 18 and 24 months after completion of baseline survey. The primary outcome is the employees´ achievement of sustainable RTW, defined as reporting less than six weeks of working days missed out due to sickness absence within 12 months after first RTW. Secondary outcomes include health-related quality of life, mental functioning, RTW self-efficacy, overall job satisfaction, severity of mental illness and work ability. The health-economic evaluation will be conducted from a societal and public health care perspective, as well as from the employer's perspective in a cost-benefit analysis. The design will be supplemented by a qualitative effect evaluation using pre- and post-interviews, and a multimethod process evaluation examining various predefined key process indicators from different stakeholder perspectives. DISCUSSION: By applying a comprehensive, multimethodological evaluation design, this study captures various facets of RTW-PIA. In case of promising results for sustainable RTW, RTW-PIA may be integrated into standard care within German psychiatric outpatient clinics. TRIAL REGISTRATION: The study was prospectively registered with the German Clinical Trials Register ( DRKS00026232 , 1 September 2021).

Online therapy: an added value for inpatient routine care? Perspectives from mental health care professionals.

Internet-delivered interventions can be effective in treating mental disorders. However, their rate of use in German psychiatric inpatient routine care is low. The current study aimed to investigate the attitude of mental health care professionals working in inpatient care regarding internet-delivered interventions, including presumed benefits, barriers and facilitators. In total, 176 health professionals from ten inpatient psychiatric hospitals throughout Germany were surveyed on site. The professionals' attitude towards internet-delivered interventions in inpatient care was assessed by an adapted version of the 'Attitude toward Telemedicine in Psychiatry and Psychotherapy' (ATTiP) questionnaire. To identify benefits, barriers and facilitators, we developed open-response questions that were based on the 'Unified Theory of Acceptance and Use of Technology' (UTAUT) and analyzed by a qualitative content analysis. Professionals reported little experience or knowledge about internet-delivered interventions. Their attitude towards internet-delivered interventions in psychiatric inpatient care was rather indifferent. The most frequently mentioned potential benefits were an optimised treatment structure and patient empowerment; the most frequently anticipated barriers were too severe symptoms of patients, the feared neglect of face-to-face contacts and insufficient technical equipment; and the most frequently mentioned facilitators were high usability of the internet-based intervention, a sufficient functional level of the patient and further education of staff. For successful implementation in the inpatient sector, internet-delivered interventions must be adapted to the special needs of severely mentally ill patients and to the hospital management systems and workflow. In addition, technical preconditions (internet access, devices) must be met. Last, further education of mental health care professionals is needed.

[E-Mental Health and healthcare apps in Germany]. / E-Mental-Health und digitale Gesundheitsanwendungen in Deutschland.

Digitalization trends are having an impact on mental healthcare. Online interventions can promote mental health and complement existing mental healthcare services. Effective online interventions have been developed for a variety of mental health disorders and, overall, patient and practitioner acceptance of such programs is high. The Digital Healthcare Act provides the legal framework for the use of healthcare apps in German routine care. After approval by the Federal Institute for Drugs and Medical Devices, the costs of certain healthcare apps are now covered by statutory health insurers. However, digital technologies have rarely been used in mental healthcare to date. Reasons include a low level of awareness of such programs as well as a large number of untested applications. Specified quality criteria can provide better orientation for patients and healthcare providers. Further implementation efforts are necessary in order to fully use the potential of digital support options in psychiatric and psychotherapeutic care for the benefit of patients.

[Treatment clusters and personnel assessment in psychosomatic medicine and psychotherapy - results of a feasibility study of the platform model]. / Behandlungscluster und Personalbemessung in der psychosomatischen Medizin und Psychotherapie ­ Ergebnisse einer Machbarkeitsstudie zum Plattformmodell.

Treatment clusters and personnel assessment in psychosomatic medicine and psychotherapy - results of a feasibility study of the platform model Objectives: In accordance with the legal requirements of the PsychVVG, it is necessary to develop criteria for inpatient and day-care psychosomatic psychotherapeutic care, which can be used to determine the appropriate staffing for different treatment areas and different care structures. For psychosomatic medicine and psychotherapy a model with four treatment clusters was developed, which is oriented on the one hand to the psychotherapeutic intensity and on the other hand to the medical expenditure. Method: In three consecutive rounds with up to 30 experts, representative selected from the three institution types university hospital, departmental psychosomatic medicine and specialized clinic, the minute values per patient required for a treatment according to the guidelines were determined using the Delphi method. Newly developed activity profiles for the six occupational groups were used, which allow the recording of all patient- and setting-related activities. Results: With the results of the feasibility study, an instrument has been developed for the first time to determine the requirements of staffing in psychosomatic medicine. Convergent minute values could be formulated for three of the four treatment clusters. Conclusions: The provision of care in psychosomatic medicine and psychotherapy is complex, so that a limitation to four treatment areas is only possible if significantly more generous equivalence rules are applied between the professional groups than those laid down in the PPP Directive.

[Finding the needles in the haystack: quality criteria for the use of internet-based self-management interventions in the prevention and treatment of mental disorders]. / Die Nadeln im Heuhaufen finden: Qualitätskriterien für den Einsatz von internetbasierten Selbstmanagement-Interventionen in Prävention und Behandlung psychischer Störungen.

Numerous self-management interventions have proven to be efficacious in the treatment of a number of mental disorders in randomized trials. However, these interventions have not yet reached clinical routine everywhere. Among other things, this is due to the fact that, in addition to the evidence-based interventions, other interventions are offered that have never been scientifically investigated, and in some cases, do not even rely on evidence-based methods of psychotherapy. The present quality criteria, developed by the two professional associations DGPs and DGPPN, are intended to help patients, practitioners and decision-makers in the health care sector to identify safe and efficacious interventions. The core quality criteria cover the following aspects: safety of patients and their data; ensuring therapeutic quality by using evidence-based psychotherapeutic methods and developing the intervention in liaison with licensed psychotherapists or medical specialists; the presence of proof of efficacy from at least one randomized trial; and transparency regarding key information, e. g., the cost of the intervention. We hope that these criteria can contribute to the inclusion of self-management interventions in the range of services covered by statutory health insurance companies.

[Staffing of inpatient psychiatric facilities : A patient-oriented and guideline-oriented staffing concept]. / Personalausstattung in stationären psychiatrischen Einrichtungen : Ein patientenorientiertes und leitliniengerechtes Konzept zur Personalbemessung.

BACKGROUND AND GOAL: According to § 136a (2) SGB V (volume V of the German Social Security Code) the German legislator instructed the Federal Joint Committee (G-BA) to specify binding minimum standards for the staff needed for the treatment in inpatient psychiatric and psychosomatic facilities. This induced the expert associations/organizations to develop their own conceptional approach as to the future organization of staffing. METHOD: Organization of regular expert workshops, the results of which were systematically documented and validated by the experts. RESULTS: The essential elements of the concept are: the starting points for the calculation are the needs of all patients treated in the institution. The need for treatment has three dimensions: (a) psychiatric psychotherapeutic/psychosomatic psychotherapeutic/pediatric and adolescent psychiatric-psychotherapeutic, (b) somatic and (c) psychosocial needs. The model developed by the platform distinguishes between staff requirements being directly related to the treatment of the individual patient, staff requirements caused by the treatment setting and such staff requirements arising at an institutional level. Minimum staff requirement is understood as the staff structure which is, among others, needed to guarantee the multiprofessional, physician-led treatment and the required medical care services for all patients specified by the existing guidelines or an expert consensus as well as to ensure the protection of the patient, fellow patients and the employees working in the facility against hazards. CONCLUSION: This model considers the medical progress within the meaning of the evidence-based guidelines and the modified healthcare practice including sociopolitical standards aimed at the patients' self-determination.

A standardized stepwise drug treatment algorithm for depression reduces direct treatment costs in depressed inpatients - Results from the German Algorithm Project (GAP3).

BACKGROUND: In a previous single center study we found that a standardized drug treatment algorithm (ALGO) was more cost effective than treatment as usual (TAU) for inpatients with major depression. This report aimed to determine whether this promising initial finding could be replicated in a multicenter study. METHODS: Treatment costs were calculated for two time periods: the study period (from enrolment to exit from study) and time in hospital (from enrolment to hospital discharge) based on daily hospital charges. Cost per remitted patient during the study period was considered as primary outcome. RESULTS: 266 patients received ALGO and 84 received TAU. For the study period, ALGO costs were significantly lower than TAU (ALGO: 7 848 ± 6 065 €; TAU: 10 033 ± 7 696 €; p = 0.04). For time in hospital, costs were not different (ALGO: 14 734 ± 8 329 €; TAU: 14 244 ± 8 419 €; p = 0.617). Remission rates did not differ for the study period (ALGO: 57.9%, TAU: 50.0%; p=0.201). Remission rates were greater in ALGO (83.3%) than TAU (66.2%) for time in hospital (p = 0.002). Cost per remission was lower in ALGO (13 554 ± 10 476 €) than TAU (20 066 ± 15 391 €) for the study period (p < 0.001) and for time in hospital (ALGO: 17 582 ± 9 939 €; TAU: 21 516 ± 12 718 €; p = 0.036). LIMITATIONS: Indirect costs were not assessed. Different dropout rates in TAU and ALGO complicated interpretation. CONCLUSIONS: Treatment algorithms enhance the cost effectiveness of the care of depressed inpatients, which replicates our prior results in an independent sample.

How Effective Is Algorithm-Guided Treatment for Depressed Inpatients? Results from the Randomized Controlled Multicenter German Algorithm Project 3 Trial.

Background: Treatment algorithms are considered as key to improve outcomes by enhancing the quality of care. This is the first randomized controlled study to evaluate the clinical effect of algorithm-guided treatment in inpatients with major depressive disorder. Methods: Inpatients, aged 18 to 70 years with major depressive disorder from 10 German psychiatric departments were randomized to 5 different treatment arms (from 2000 to 2005), 3 of which were standardized stepwise drug treatment algorithms (ALGO). The fourth arm proposed medications and provided less specific recommendations based on a computerized documentation and expert system (CDES), the fifth arm received treatment as usual (TAU). ALGO included 3 different second-step strategies: lithium augmentation (ALGO LA), antidepressant dose-escalation (ALGO DE), and switch to a different antidepressant (ALGO SW). Time to remission (21-item Hamilton Depression Rating Scale ≤9) was the primary outcome. Results: Time to remission was significantly shorter for ALGO DE (n=91) compared with both TAU (n=84) (HR=1.67; P=.014) and CDES (n=79) (HR=1.59; P=.031) and ALGO SW (n=89) compared with both TAU (HR=1.64; P=.018) and CDES (HR=1.56; P=.038). For both ALGO LA (n=86) and ALGO DE, fewer antidepressant medications were needed to achieve remission than for CDES or TAU (P<.001). Remission rates at discharge differed across groups; ALGO DE had the highest (89.2%) and TAU the lowest rates (66.2%). Conclusions: A highly structured algorithm-guided treatment is associated with shorter times and fewer medication changes to achieve remission with depressed inpatients than treatment as usual or computerized medication choice guidance.

Characteristics and differences in treatment outcome of inpatients with chronic vs. episodic major depressive disorders.

BACKGROUND: Approximately 20-30% of patients with Major depressive disorder (MDD) develop a chronic course of their disease. Chronic depression is associated with increased health care utilisation, hospitalisation and a higher disease burden. We identified clinical correlates and differences in treatment response of chronic MDD (cMDD) patients compared with non-chronic episodic depression in a huge sample of depressive inpatients. METHODS: Data were collected from 412 inpatients who had been diagnosed with a major depressive episode (MDE; according to ICD-10) and scored 15 or higher on the 21-item Hamilton Depression Rating Scale (HRSD-21). All subjects were participants in the German Algorithm Project, phase 3 (GAP3). Patients who were diagnosed with a MDE within the last two years or longer (herein referred to as CD) were compared with non-chronic depressive patients (herein referred to as non-CD). CD and non-CD patients were assessed for the following: psychosocial characteristics, symptom reduction from hospital admission to discharge, symptom severity at discharge, remission and response rates, and pharmacological treatment during inpatient treatment. The primary outcome measure was the HRSD-21. RESULTS: 13.6% (n=56) of patients met the criteria for chronic depression. Compared with non-CD patients, patients with CD showed increased axis I comorbidities (74% vs. 52%, χ(2) (1)=7.31, p=.02), a higher level of depressive symptoms at baseline and discharge, increased duration of inpatient treatment (64.8 vs. 53.3 days; t=2.86, p=.03) and lower response (HRSD: 60.0% vs. 72.0%; χ(2) (1)=3.61, p<.04; BDI: 40.5% vs. 54.2%; χ(2) (1)=3.56, p=.04) and remission rates (BDI 17.9.% vs. 29.7%; χ(2) (1)=3.42, p=.05. However, both groups achieved a comparable symptom reduction during inpatient treatment. The prescribed pharmacological strategy had no significant influence on treatment outcome in patients with CD. CONCLUSION: Inpatients with CD show higher symptom severity, lower response and remission rates and a longer duration of inpatient treatment, although they achieve comparable symptom reduction during treatment. These findings support the need to recognise CD and its defining characteristics as a distinct subclass of depression.

[Actual care and funding situation with regard to mother-child units for psychic disorders associated with pregnancy in Germany]. / Aktuelle Versorgungs- und Finanzierungslage von Mutter-Kind-Einheiten für schwangerschaftsassoziierte psychische Störungen in Deutschland.

UNLABELLED: CONCERN: The current care and financial situation of mother-child units for psychic disorders associated with pregnancies in Germany should be documented in preparation for the development of the new reimbursement system for psychiatry and psychosomatics. METHOD: In accordance with the last survey of 2005, a brief questionnaire was developed and a nationwide poll was conducted. RESULTS: The survey revealed severe (10 fold) service deficits for severely and gravely mentally ill mothers, who require an inpatient treatment with specific professional competence. Compared with the last poll, these service deficits have increased. This is due to continued insufficient funding and unresolved financing in the new reimbursement system. With the establishment of an additional code for mother-child treatment the precondition for ensuring the funding of this important care form in the new reimbursement system was created. CONCLUSION: It is to be hoped that the decision-makers of health policy will finally face up to their social responsibility and ensure adequate funding of the additional diagnostic and therapeutic expenditure of mother-child treatment. The health care providers have an obligation to implement a transparent record of services of the additional expenditure and to augment the national evaluation approaches to inpatient mother-child treatments.

[Legal aspects of delegation and reorganisation of medical services in the psychiatric field]. / Rechtliche Aspekte von Delegation und Neuorganisation ärztlicher Tätigkeiten im psychiatrischen Fachgebiet.

Current psychiatric-psychotherapeutic in-patient care takes place in an area of tension between increasing treatment requirements and the persistent lack of qualified staff. The optimisation of the diagnostic-therapeutic procedures in a clinic helps to reduce existing care deficits or to generate resources for future developments. The subject of delegation and substitution of medical services is considered in this context. Inadequate knowledge of the legal situation on the part of the decision makers impairs the indispensable trustful cooperation among the professions and adds to the uncertainty of all those concerned. The present paper outlines the legal, organisational and health policy aspects of delegation and the reorganisation of medical activities in the field of psychiatry.

[Definition of the core area of medical services in the psychiatric-psychotherapeutic field--the prerequisite for any delegation]. / Definition des Kernbereichs ärztlicher Tätigkeit im psychiatrisch-psychotherapeutischen Fachgebiet--Voraussetzung für jede Delegation.

Based on legal jurisdiction, knowledge of the psychiatric-psychotherapeutic field and insight into the necessity of a new allocation of responsibilities in the overall therapeutic service of a clinic, the core areas of medical activities are defined for the first time, innovative organisational approaches to the reorganisation of therapeutic service are presented and discussed against the background of qualified staff deficit, introduction of an OPS coding for inpatient psychiatry and economic constraints.

[Shortage of doctors in psychiatric hospitals--providing for the future by reorganizing medical services]. / Ärztemangel im psychiatrischen Krankenhaus--Zukunftssicherung durch Neuordnung des ärztlichen Dienstes.

Increasing psychiatric disorder treatment need, increased work load, changes in the working hour regulations, the nation-wide shortage of physicians, efficiency principle and economisation can necessitate a reorganisation of medical services. The essential steps and instruments of process optimisation in medical services for a psychiatric clinic are elucidated and discussed in the context of demographic changes, generation change, and a new concept of values.

[Reorganisation of the diagnostic and therapeutic courses in the psychiatric care centre--from the analysis to implementation]. / Neuorganisation der diagnostischen und therapeutischen Abläufe im psychiatrischen Versorgungszentrum--von der Analyse zur Umsetzung.

Under current conditions psychiatric-psychotherapeutic inpatient care can not be sustained in its present form for much longer. Therefore, our main priority must be to adapt the care structures to the changes in society and psychiatry under consideration of the patients' needs. Cooperation, integration, and interlocking of cross-sectoral and interdisciplinary treatment provision are the challenge of the next decade. They will require networked organisation forms of high complexity as well as new mindsets and approaches. Significant steps and instruments of a structural transformation in the overall therapeutic services are elucidated using the example of a psychiatric care centre and discussed in connection with the introduction of a new reimbursement system for psychiatric and psychosomatic facilities in 2013. New cross-sectoral concepts could ensure care, particularly in regions with lacking or inadequate outpatient structure. Management competences combined with holistic thinking can help to create patient-centred alignments in this context.