Plans for assessment and collection of outcomes {18a}
Screening will take place at local mental health care facilities, and GBV team members will collect the data in paper-based form. The local research worker will collect further data (from t0 to t4) at a location of the study participant’s choosing, primarily in electronic form. If electronic data collection is not possible, the data will be collected on paper and electronically transferred later. Informal caregivers will be asked to fill out paper-based questionnaires on their own and send them by mail to the coordinating centre. Centralised electronic data capture is intended for these questionnaires. If necessary, specific issues will be clarified by phone.
Study-specific questionnaires will be compiled for sociodemographic data, medical history, living conditions, and social life. At the follow-up assessments (t1, t2, t3, and t4), a study-specific fidelity scale will be used to assess interventional compliance among the service providers and to gain ancillary information about the importance of and the satisfaction with local community mental health services from the patients’ perspective. In addition, all local GBV providers will be asked to answer a catalogue of quality criteria for community mental health care as defined on the basis of the S3 guideline “Psychosocial Therapies for Severe Mental Illnesses” of the DGPPN [1] in order to check for adequate implementation of GBV. Standardised questionnaires will be used to assess further process variables such as interprofessional collaboration and recovery orientation.
Only standardised questionnaires with known and at least satisfactory psychometric characteristics will be used to assess the outcomes:
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Assessment of Empowerment in Patients with Affective and Schizophrenic Disorders (EPAS) [14]
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Questionnaire of Treatment Satisfaction (ZUF8) [15, 16]
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World Health Organisation Quality of Life—short version (WHO-QoL-BREF) [17]
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Camberwell Assessment of Need—European version (CAN) [18, 19]
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Health of the Nation Outcome Scale (HoNOS) [20,21,22,23]
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Euro Quality of Life—5 dimensions (EQ-5D) [25]
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Client Sociodemographic and Service Receipt Inventory (CSSRI) [24]
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Involvement Evaluation Questionnaire (IEQ-EU) [26]
The primary outcome will be measured by means of the EPAS, which measures empowerment as the patient’s perceived possibilities to control his or her own life on five dimensions: daily living, social relationships and sexuality, psychiatric treatment, hope and self-efficacy and self-esteem. This self-assessment instrument has 33 items and five additional items each for patients who are employed and for patients with minor children. Cronbach’s α = 0.94 was obtained for the total scale [14]. Originally developed to assess empowerment in patients with affective and schizophrenic disorders, the EPAS has also proved to be reliable in patients with other types of severe mental disorders [10, 28].
The German short version of the Client Satisfaction Questionnaire (CSQ8), published as Fragebogen zur Patientenzufriedenheit (ZUF8) [15, 16], is a suitable tool for measuring patient satisfaction with their mental health care.
The WHO-QoL-BREF captures the patients’ subjective quality of life in the dimensions of physical health, mental well-being, social relationships, and environmental conditions. The WHO-QoL-BREF is a self-assessment tool with 25 items [17].
The CAN records patients’ perceived needs and the extent to which they are met, covering 23 areas. No special knowledge is required to work with this instrument [18, 19].
The HoNOS measures the clinical and psychosocial impairment of patients in twelve dimensions, independent of diagnosis. After an appropriate briefing, members of all mental health professions can carry out the HoNOS assessment [20,21,22,23].
The EQ-5D enables the assessment of health conditions as a basis for determining quality-adjusted life years (QALY) [25].
The use of health and psychosocial care services will be recorded using the CSSRI [24]. Health care costs are estimated by multiplying the service units used by the billing costs per unit for a 6-month period. For the health economic analysis from the perspective of statutory health insurance, expenditures will be determined on the basis of billing data.
The German version of the Involvement Evaluation Questionnaire (IEQ-EU) [11] will be used to assess the burden on informal caregivers.
To assess treatment satisfaction and subjective quality of life, the same instruments will be used for informal caregivers as for patients, specifically the ZUF8 [15, 16] and the WHO-QoL-BREF [17].
Dropouts and adverse events will be documented on standardised forms at the next follow-up assessment, at the latest.
Only trained GBV team members will administer the EPAS, CAN, and HoNOS and lead the enrolment procedure. A contact person at the coordinating centre will be available to GBV team members throughout the course of the study to answer questions on participant enrolment and screening. Refresher trainings will be offered as needed.
All local research workers have been trained and will follow uniform standard operating procedures (SOP) as to good clinical practice (GCP), recruitment, assessment, and questionnaires, for example. Advanced training sessions (e.g. training in HoNOS evaluation) of the research associates will be part of biannual project meetings. During the study, local research workers will be regularly tested for interrater reliability on the HoNOS and CAN using case vignettes.
Research workers at the coordinating centre will check the quality of data collection at each site during semiannual monitoring visits. The results will be documented in a monitoring report, which will be sent back to the local research workers and considered for the final analysis and interpretation of the data. The focus of the monitoring will primarily be on site monitoring, i.e. whether the local research workers are conducting the study in accordance with the given SOP. Furthermore, the monitoring will involve checking the completeness and plausibility of the available study documents. During the 1-year recruitment phase, the inclusion of study participants in accordance with the study protocol will be checked (e.g. by checking their eligibility and informed consent). Thereafter, the monitor will focus on the completeness and plausibility of the collected data and the documentation of serious adverse events. In addition, the monitor will offer support in case of questions or ambiguities in terms of participant recruitment, study conduct, and data collection and reporting, thus contributing to increased data quality.
Plans to promote participant retention and complete follow-up {18b}
Participants will receive reimbursement for study participation (€25 per study visit, from t0 to t4) and, if applicable, for their expenses for travelling to the interview location.
Data management {19}
Data will primarily be collected using the survey software SoSci Survey (SoSci Survey GmbH, Munich). The value ranges for the individual questions are defined in the electronic form of the questionnaire. A check for missing values is performed for each questionnaire in the electronic form. If not feasible, a paper version of the questionnaire will be used and transcribed into electronic format by the local research worker within 1 week. In order to check the data entry, staff at the coordinating centre in Ulm will re-enter a randomly chosen 5% sample of the paper-based data and subsequently compare the data sets.
All collected data will be regularly requested and stored on servers at the Department for Psychiatry and Psychotherapy II of Ulm University. Research workers at the coordinating centre at Ulm University will process and analyse the data. The data processing will include electronic data checks for plausibility and completeness as well as subsequent preparation for analysis. The data will be processed and evaluated with the software packages SPSS and SAS, among others.
The coordinating centre will oversee the whole study process by frequently communicating with local research workers regarding outstanding issues, checking the data collection procedure, and sending queries, if necessary.
Confidentiality {27}
The collection, storage, and analysis of study data will be carried out in compliance with the relevant data-protection regulations. All personal data will be pseudonymised during the collection. The study participants’ personal identifying data will be replaced by identifiers. The index tables for the assignment of personal data and identifiers will be access-protected and stored separately from the data.
Communication and data transfer between the research team and both the local community mental health care providers and statutory health insurances will take place using screening identifiers. Local research workers will use study identifiers (different from screening identifiers) for data collection during the baseline and follow-up assessments (from t0 to t4). The local research workers will be the only persons with access to the major index table with personal data, screening identifiers, and study identifiers.
Prior to enrolment in the study, the potential study participants will be informed orally and in writing about the study’s aims, nature, scope, and implications by local GBV team members. In addition, the potential study participants will be informed about the data-protection regulations within the study. The potential study participants will be given sufficient time to think about their participation and to ask questions. By completing the informed consent form, the potential study participant will agree to participate in the study and to the data-protection regulations.
The study results will be published in anonymous form. This means that it will not be possible to allocate study data to individual study participants since no access to the index tables will be given.
The study data will only be transferred in anonymised form to third parties.
The study data will be archived on servers at the Department for Psychiatry and Psychotherapy II of Ulm University.
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
No biological specimens for genetic or molecular analysis will be collected in this trial.