Evaluation of a Cross-sectional Coordinated, Severity Stepped, Evidence-based Care Model for Mental Disorders
NCT03459664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 905
Last updated 2021-10-05
Summary
This study evaluates a cross sectional, severity stepped, evidence-based care model for patients with mental disorders (RECOVER).
RECOVER is a consortium of well-known institutions for the treatment and integrated care of patients with mental disorders, patient associations, relative associations, research institutions, health care insurances and authorities from the care region Hamburg, Germany.
This project aims to evaluate the RECOVER care model with treatment as usual (TAU) regarding cost-effectiveness (costs, efficiency and cost utility) for patients with mental disorders.
The following questions are examined:
1. Does RECOVER reduce psychiatric health care costs compared to TAU?
2. Does RECOVER improve patient relevant outcomes (i.e. symptom remission, response, daily functioning and quality of life)?
3. Is RECOVER cost effective compared to TAU? (from a payer's and societal perspective)
A total sample of 890 patients with mental disorders will be assessed at baseline (before treatment) and randomized into the RECOVER care model or get TAU. Follow-up assessments are conducted after 6 month and 12 month.
As primary outcomes, cost reduction, improvement in symptoms (i.e. amount of remission and response to treatment, daily functioning and quality of life) and cost-efficiency-ratios will be measured. In addition, several secondary outcome parameters will be assessed.
Impact: The present randomized controlled trial (RCT) evaluates the cross-sectional, severity stepped, evidence-based approach of the RECOVER model in patients with mental disorders. With its focus on effectiveness and cost-effectiveness, the study aims to improve the health care system in Germany.
Conditions
- Delivery of Health Care
Interventions
- BEHAVIORAL
-
RECOVER
For each patient baseline assessment and individual support by a diagnostic and crisis resolution home treatment team is available. In addition, patients will be treated with specific interventions based on their severity grade: Grade 1 (mild): social support, information about mental disorder, e-therapy, consultation, self help, peer-support, supported employment. Grade 2 (medium): psychotherapy (stepped short-term and group therapy), if applicable medical treatment, e-therapy, peer-support, supported employment. Grade 3 (medium to severe): case management, psychotherapy (stepped short-term and group therapy), if applicable medical treatment, e-therapy, peer-support, supported employment. Grade 4 (severe): assertive community treatment, psychotherapy, medical treatment, e-therapy, peer-support, supported employment.
- BEHAVIORAL
-
Treatment as usual
For each patient all common care options within the German health care system are available, depending on the severity grade 1 to 4. This includes the following options: hospital based in-patient, out-patient treatment and day care, community based health care services, general practitioners, private psychiatrists and psychotherapists, self help.
Sponsors & Collaborators
-
Federal Ministry of Health, Germany
collaborator OTHER_GOV -
BARMER
collaborator OTHER -
AOK Rheinland/Hamburg
collaborator INDUSTRY -
DAK Gesundheit
collaborator OTHER -
HEK
collaborator UNKNOWN -
BKK Linde
collaborator UNKNOWN -
BKK Mobil Oil
collaborator INDUSTRY -
BKK Public
collaborator UNKNOWN -
BKK RWE
collaborator UNKNOWN -
BKK Salzgitter
collaborator UNKNOWN -
BKK Technoform
collaborator UNKNOWN -
BKK VerbundPlus
collaborator UNKNOWN -
Continentale BKK
collaborator UNKNOWN -
Heimat BKK
collaborator UNKNOWN -
Salus BKK
collaborator UNKNOWN -
TUI BKK
collaborator UNKNOWN -
WMF Betriebskrankenkasse
collaborator UNKNOWN -
IKK Classic
collaborator UNKNOWN -
Energie BKK
collaborator UNKNOWN -
VIACTIV Krankenkasse
collaborator UNKNOWN -
Universitätsklinikum Hamburg-Eppendorf
lead OTHER
Principal Investigators
-
Judith Peth, Dr. · University Medical Center Hamburg-Eppendorf, Institute and Outpatients Clinic Medical Psychology
-
Holger Schulz, Prof. · University Medical Center Hamburg-Eppendorf, Institute and Outpatients Clinic Medical Psychology
-
Hans-Helmut König, Prof. · Institute of Health Economics and Health Care Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-15
- Primary Completion
- 2021-01-28
- Completion
- 2021-01-28
Countries
- Germany
Study Locations
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