Evaluation of a Cross-sectional Coordinated, Severity Stepped, Evidence-based Care Model for Mental Disorders

NCT03459664 | Completed DMC

• 1 other identifier: RECOVER
• Study Type: interventional
• Target: 905
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does RECOVER reduce psychiatric health care costs compared to TAU?
2. 2.Does RECOVER improve patient relevant outcomes (i.e. symptom remission, response, daily functioning and quality of life)?
3. 3.Is RECOVER cost effective compared to TAU? (from a payer's and societal perspective)

Conditions

Delivery of Health Care

Keywords

stepped care; common mental disorders; managed care; integrated care; psychiatric disorders; psychotherapy; severe mental disorders

Outcome Measures

Primary Outcomes (3)

• health care costs

  Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show a reduction in average health care costs. Different cost-sectors are assessed, with the Questionnaire for the Assessment of Medical and non-Medical Resource Utilisation in Mental Disorders (FIMPsy, Grupp et al., 2017) and the Questionnaire for the use of medical and non-medical services in old age (FIMA, Seidl et al., 2015), and will be added up to one measure "health care costs".

  Baseline, 12 month after baseline

• psycho-functional level

  Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an improvement in the psycho-functional level. The psycho-functional level is assessed as a combined outcome criterion (Aiken, 1987). For this purpose, scores of the Psychopathological Symptom Severity Scale of the Hamburg Modules for the Assessment of Psychosocial Health (HEALTH 49, Rabung, et al., 2007), the Global Assessment of Functioning Scale (GAF; Gold, 2014), and the Mental Component Summary of the Short Form Health-Questionnaire (SF-12, Ware et al., 1996) will be linearly transformed and added up to one measure "psycho-functional level".

  Baseline, 12 month after baseline

• incremental cost-effectiveness ratio (ICER)

  Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU shows an improvement in the incremental cost-effectiveness ratio (ICER). The ICER is calculated as the ratio of the difference in costs between RECOVER and TAU to the difference in quality adjusted-life years (QALYs) between RECOVER and TAU.

  Baseline, 12 month after baseline

Secondary Outcomes (18)

• severity of illness

  Baseline, 12 month after baseline

• global functioning

  Baseline, 12 month after baseline

• recovering quality of life

  Baseline, 12 month after baseline

• symptomatic remission

  Baseline, 12 month after baseline

• functional remission

  Baseline, 12 month after baseline

Study Arms (2)

RECOVER

EXPERIMENTAL

The intervention in the RECOVER stepped-care model includes specific evidence-based treatment options for severity grade 1 to 4.

Behavioral: RECOVER

Treatment As Usual

ACTIVE COMPARATOR

The active comparator is treatment as usual (TAU) and provides all common care options within the German health care system, depending on the severity grade 1 to 4.

Behavioral: Treatment as usual

Interventions

RECOVER BEHAVIORAL

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.

RECOVER

Treatment as usual BEHAVIORAL

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.

Treatment As Usual

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥16 years
• insured in one of the relevant health insurances (BARMER GEK, AOK Rheinland/Hamburg, DAK Gesundheit, HEK, BKK Linde, BKK Mobil Oil, BKK Public, BKK RWE, BKK Salzgitter, BKK Technoform, BKK VerbundPlus, Continentale BKK, Heimat BKK, Salus BKK, TUI BKK, WMF Betriebskrankenkasse, IKK Classic, VIACTIV Krankenkasse)
• at least diagnosed with one of the relevant psychiatric disorders: Schizophrenic disorders (ICD-10: F20, F22, F23, F25); bipolar disorder (ICD-10: F31); major depressive disorder (ICD-10: F32, F33); anxiety disorder (ICD-10: F40, F41); obsessive compulsive disorder (ICD-10: F42); post traumatic stress disorder (ICD-10: F43.1); adjustment disorder (ICD-10: F43.2); somatoform disorder (ICD-10: F45); eating disorder (ICD-10: F50); personality disorder (ICD-10: F60, F61); attention-deficit hyperactivity disorders (ICD-10: F90);
• living in the surrounding area of the university medical center Hamburg-Eppendorf

You may not qualify if:

• disorder belonging to ICD-10 F0 (mental disorders due to known physiological conditions) or F1 (primary disorders due to psychoactive substance use)
• severe to most severe low intelligence (previously diagnosed ICD-10: F72/F73)
• insufficient language skills
• uncorrected visual and/or hearing impairment

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Federal Ministry of Health, Germany: collaborator
• BARMER: collaborator
• AOK Rheinland/Hamburg: collaborator
• DAK Gesundheit: collaborator
• HEK: collaborator
• BKK Linde: collaborator
• BKK Mobil Oil: collaborator
• BKK Public: collaborator
• BKK RWE: collaborator
• BKK Salzgitter: collaborator
• BKK Technoform: collaborator
• BKK VerbundPlus: collaborator
• Continentale BKK: collaborator
• Heimat BKK: collaborator
• Salus BKK: collaborator
• TUI BKK: collaborator
• WMF Betriebskrankenkasse: collaborator
• IKK Classic: collaborator
• Energie BKK: collaborator
• VIACTIV Krankenkasse: collaborator

Study Sites (1)

University Medical Center Hamburg-eppendorf

Hamburg, 20246, Germany

Location

Related Publications (3)

• Schindler A, Warkentin HF, Bierbrodt J, Konig H, Konnopka A, Pepic A, Peth J, Lambert M, Gallinat J, Karow A, Konig HH, Harter M, Schulz H, Rohenkohl A, Krog K, Biedermann SV, Schafer I. Dialectical behavior therapy (DBT) in an assertive community treatment structure (ACT): testing integrated care borderline (ICB) in a randomized controlled trial (RECOVER). Borderline Personal Disord Emot Dysregul. 2024 Aug 14;11(1):18. doi: 10.1186/s40479-024-00261-4.

  PMID: 39138537 DERIVED

• Konig H, Konig HH, Gallinat J, Lambert M, Karow A, Peth J, Schulz H, Konnopka A. Excess costs of mental disorders by level of severity. Soc Psychiatry Psychiatr Epidemiol. 2023 Jun;58(6):973-985. doi: 10.1007/s00127-022-02298-8. Epub 2022 May 31.

  PMID: 35639134 DERIVED

• Lambert M, Karow A, Gallinat J, Ludecke D, Kraft V, Rohenkohl A, Schroter R, Finter C, Siem AK, Tlach L, Werkle N, Bargel S, Ohm G, Hoff M, Peter H, Scherer M, Mews C, Pruskil S, Luke J, Harter M, Dirmaier J, Schulte-Markwort M, Lowe B, Briken P, Peper H, Schweiger M, Mosko M, Bock T, Wittzack M, Meyer HJ, Deister A, Michels R, Herr S, Konnopka A, Konig H, Wegscheider K, Daubmann A, Zapf A, Peth J, Konig HH, Schulz H. Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). BMJ Open. 2020 May 4;10(5):e036021. doi: 10.1136/bmjopen-2019-036021.

  PMID: 32371520 DERIVED

Related Links

• Homepage of the RECOVER model

MeSH Terms

Conditions

Mental Disorders

Interventions

Therapeutics

Study Officials

• Judith Peth, Dr.

  University Medical Center Hamburg-Eppendorf, Institute and Outpatients Clinic Medical Psychology

  PRINCIPAL INVESTIGATOR

• Holger Schulz, Prof.

  University Medical Center Hamburg-Eppendorf, Institute and Outpatients Clinic Medical Psychology

  PRINCIPAL INVESTIGATOR

• Hans-Helmut König, Prof.

  Institute of Health Economics and Health Care Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals who evaluate the outcomes of interest will remain blinded regarding a participant's condition (RECOVER/TAU) over the course of the study. Randomization will be conducted after baseline assessment and communicated to the participant by a person that is not the outcome assessor. During follow-up assessments after 6 and 12 month the outcome assessor will remain blinded regarding a participant's condition.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled study with two arms (RECOVER or treatment as usual)

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: March 9, 2018
• Study Start: March 15, 2018
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

DE (1)