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

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ClinicalTrials.gov Identifier: NCT03459664
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborators:
Federal Ministry of Health, Germany
BARMER GEK
AOK Rheinland/Hamburg
DAK Gesundheit
HEK
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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. 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 1070 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.


Condition or disease Intervention/treatment Phase
Delivery of Health Care Behavioral: RECOVER Behavioral: Treatment as usual Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1070 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled study with two arms (RECOVER or treatment as usual)
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: Evaluation of a Cross-sectional Coordinated, Severity Stepped, Evidence-based Care Model for Mental Disorders
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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


Active Comparator: Treatment As Usual
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

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.





Primary Outcome Measures :
  1. health care costs [ Time Frame: Baseline, 12 month after baseline ]
    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".

  2. psycho-functional level [ Time Frame: Baseline, 12 month after baseline ]
    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".

  3. incremental cost-effectiveness ratio (ICER) [ Time Frame: Baseline, 12 month after baseline ]
    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.


Secondary Outcome Measures :
  1. severity of illness [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU lead to a greater reduction of severity of illness, assessed with the Clinical Global Impressions- Severity Scale (CGI-S; Guy 1976). The CGI-S requires a clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The following ratings are possible: 0 = not applicable; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.

  2. global functioning [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU lead to a greater improvement of global functioning, assessed with the Global Assessment of Functioning scale (GAF; Gold, 2014). GAF scores range from 100 (extremely high functioning) to 1 (severely impaired).

  3. recovering quality of life [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU lead to a greater recovering quality of life, assessed with the Recovering Quality of Life questionnaire (Re-QOL-20, Keetharuth et al., 2017). Re-QOL-20 scores range from 0 to 80, where 0 indicates poorest quality of life and 80 indicates highest quality of life.

  4. symptomatic remission [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show a higher proportion of symptomatic remission (number of patients). Symptomatic remission is defined according to Guy et al. (1975) with a value of ≤ 3 points in the severity score of clinical global impression scale (no greater than "mild") for ≥ 6 months.

  5. functional remission [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show a higher proportion of functional remission (number of patients). Functional remission according to the criterion by Albert et al. (2012), measured with the global assessment of functioning scale (GAF; Gold, 2014) fulfilled when a value of ≥ 60 points persisted for ≥ 6 months.

  6. rate of psychiatric hospitalizations [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show a reduction of psychiatric hospitalizations (number of hospitalizations since baseline)

  7. duration of psychiatric hospitalizations [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show a reduction in the duration of psychiatric hospitalizations (number of days in hospitalizations since baseline)

  8. incapacity to work [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show a reduction in incapacity to work (number of days since baseline)

  9. delay of treatment [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show a reduction in delay of diagnosis specific treatment (number of days between baseline and start of treatment).

  10. evidence-based interventions [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an increase of guideline directed treatment, according to specific diagnosis and severity grade (number of patients with guideline directed treatment)

  11. out-patient psychotherapeutic interventions for severe mental disorders [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an increase of patients with severe mental disorders in out-patient psychotherapeutic interventions (number of patients)

  12. psychotherapeutic group interventions [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an increase of group psychotherapeutic interventions (number of patients)

  13. psychotherapeutic short-term interventions [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an increase of psychotherapeutic short-tern interventions (number of patients)

  14. specific psychiatric interventions for severe mental disorders [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an increase of specific psychiatric interventions for severe mental disorders (number of crisis resolution and assertive community treatment)

  15. treatment retention [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an improvement in treatment retention rate (days until drop out after baseline)

  16. drop out rate [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an improvement in drop-outs during treatment (number of drop outs)

  17. web-based therapy [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an improvement in utilization of web-based therapy (number of users).

  18. peer-support [ Time Frame: Baseline, 12 month after baseline ]
    Inclusion in the treatment arm of the RECOVER trial for a maximum of 12 month from baseline compared to TAU show an improvement in utilization of peer-support (number of users)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥16 years
  • insured in one of the relevant health insurances (BARMER GEK, AOK Rheinland/Hamburg, DAK Gesundheit, HEK, IKK classic)
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459664


Contacts
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Contact: Martin Lambert, Prof. +49 (0) 40 7410 - 24041 lambert@uke.de
Contact: Anne Karow, Prof. +49 (0) 40 7410 - 57728 karow@uke.de

Locations
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Germany
University Medical Center Hamburg-eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Martin Lambert, Prof.       lambert@uke.de   
Contact: Anne Karow, Prof       karow@uke.de   
Principal Investigator: Judith Peth, Dr.         
Principal Investigator: Holger Schulz, Prof         
Principal Investigator: König Hans-Helmut, Prof         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Federal Ministry of Health, Germany
BARMER GEK
AOK Rheinland/Hamburg
DAK Gesundheit
HEK
Investigators
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Principal Investigator: 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

Additional Information:
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03459664     History of Changes
Other Study ID Numbers: RECOVER
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
stepped care
common mental disorders
managed care
integrated care
psychiatric disorders
psychotherapy
severe mental disorders

Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders