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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459664 on ClinicalTrials.gov