Administrative information
Title {1} | Effectiveness and cost-effectiveness of a community-based mental health care programme (GBV) for people with severe mental illness in Germany: study protocol for a randomised controlled trial |
Trial registration {2a and 2b}. | German Clinical Trial Register DRKS00019086 Item 2b is met |
Protocol version {3} | 03/04/2020 Version 1.0 |
Funding {4} | This study is funded by the Innovation Fund of the Federal Joint Committee (G-BA), grant number 01NVF18028 (GBV). |
Author details {5a} | Dr Annabel Sandra Mueller-Stierlin,1,2 Friedrich Meixner,1 Anne Kohlmann,1 Mara Schumacher,1 Anke Hänsel,1 Melanie Pouwels,1 Nicole Bias,1 Sabrina Hartl,1 Jessica Reichstein,3 Dr Elke Prestin,3 Nils Greve,3 Prof Dr Thomas Becker,1 Prof Dr Reinhold Kilian1 1 Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany 2 Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany 3 Dachverband Gemeindepsychiatrie, Cologne, Germany. |
Name and contact information for the trial sponsor {5b} | Nils Greve, Dachverband Gemeindepsychiatrie, Cologne, Germany. Phone: +49 163 2482112, mail: greve@psychiatrie.de |
Role of sponsor {5c} | The sponsor initiated the trial and was involved in designing the study. Representatives of the sponsor—NG, EP, and JR—belong to the trial steering committee. The sponsor will not be involved in the collection, management, analysis, or interpretation of the data, or in the decision to submit the report for publication. |
Introduction
Background and rationale {6a}
Objectives {7}
-
Community-based mental health institutions can integrate GBV into regular mental health care for people with severe mental illness.
-
The indications for GBV can be assessed validly and reliably based on objective criteria.
-
Compared to CAU, the use of GBV leads to a stronger empowerment effect, made apparent by an improved subjective ability to live a self-determined and self-reliant way of life, independently arrange social relationships, actively participate in mental health care, and have increased expectations of self-efficacy and future expectations (primary outcome criterion).
-
Compared to CAU, the use of GBV leads to a stronger improvement of subjective quality of life as well as reductions to unmet care needs and the clinical and social impairment of patients related to their illness.
-
Compared to CAU, the use of GBV leads to a greater reduction in the burden on informal caregivers and to improvements in their quality of life.
-
From a health economic perspective, the use of GBV improves the cost-effectiveness ratio of the resources used, compared to CAU.
-
From the perspective of the statutory health insurance, the implementation of GBV does not lead to a significant increase in expenditures.
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
-
Minimum age: 18 years
-
Presence of mental illness in ICD-10 diagnosis groups F2, F3, F4, F5, or F6
-
Membership in a participating health insurance company
-
Permanent residence in one of the twelve defined project regions
-
Indications for GBV established by a screening assessment
-
The Assessment of Empowerment in Patients with Affective and Schizophrenic Disorders (EPAS), to determine the participants’ self-assessed ability to lead a self-determined and responsible way of life.
-
The Camberwell Assessment of Need (CAN), to determine unmet needs, which is an external assessment by members of the GBV team.
-
The Health of the Nation Outcome Scale (HoNOS), to determine patients’ clinical and social impairment due to illness, which is an external assessment by members of the GBV team.
-
Within cut-off values for all scales: no indication for GBV
-
Outside cut-off values for one or two scales: indication only with a clinical recommendation
-
Outside cut-off values for all three scales: indication for GBV
-
Primary clinical diagnosis in ICD-10 groups F0, F1, F7, F8, or F9
-
Participation in other integrated mental health care programmes in the last 6 months before recruitment
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Case management
Service planning
Crisis services
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Participant timeline {13}
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
-
Assessment of Empowerment in Patients with Affective and Schizophrenic Disorders (EPAS) [14]
-
World Health Organisation Quality of Life—short version (WHO-QoL-BREF) [17]
-
Euro Quality of Life—5 dimensions (EQ-5D) [25]
-
Client Sociodemographic and Service Receipt Inventory (CSSRI) [24]
-
Involvement Evaluation Questionnaire (IEQ-EU) [26]
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Confidentiality {27}
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Interim analyses {21b}
Methods for additional analyses (e.g. subgroup analyses) {20b}
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
-
More than 2 months between baseline assessment (t0) and initial meeting with the GBV team for participants in the intervention group
-
Noncompliance with or infrequent use of GBV by participants in the intervention group
-
Follow-up assessments (t1, t2, t3, and t4) being far outside the initially planned time periods (more than 2 months before or after the intended time points: 6 months, 12 months, 18 months, and 24 months after baseline assessment t0)