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Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER)

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Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). / Lambert, Martin; Karow, Anne; Gallinat, Jürgen; Lüdecke, Daniel; Kraft, Vivien; Rohenkohl, Anja; Schröter, Romy; Finter, Constanze Sophia; Siem, Anna-Katharina Huei-Ling; Tlach, Lisa; Werkle, Nathalie; Bargel, Susann; Ohm, Gunda; Hoff, Martin; Peter, Helmut; Scherer, Martin; Mews, Claudia; Pruskil, Susanne; Lüke, Johannes; Härter, Martin; Dirmaier, Jörg; Schulte-Markwort, Michael; Löwe, Bernd; Briken, Peer; Peper, Heike; Schweiger, Michael; Mösko, Mike-Oliver; Bock, Thomas; Wittzack, Martin; Meyer, Hans-Jochim ; Deister, Arno ; Michels, Rolf; Herr, Stephanie ; Konnopka, Alexander ; König, Hannah ; Wegscheider, Karl; Daubmann, Anne; Zapf, Antonia; Peth, Judith; König, Hans-Helmut; Schulz, Holger.

in: BMJ OPEN, Jahrgang 10, Nr. 5, 10, 04.05.2020, S. e036021.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Lambert, M, Karow, A, Gallinat, J, Lüdecke, D, Kraft, V, Rohenkohl, A, Schröter, R, Finter, CS, Siem, A-KH-L, Tlach, L, Werkle, N, Bargel, S, Ohm, G, Hoff, M, Peter, H, Scherer, M, Mews, C, Pruskil, S, Lüke, J, Härter, M, Dirmaier, J, Schulte-Markwort, M, Löwe, B, Briken, P, Peper, H, Schweiger, M, Mösko, M-O, Bock, T, Wittzack, M, Meyer, H-J, Deister, A, Michels, R, Herr, S, Konnopka, A, König, H, Wegscheider, K, Daubmann, A, Zapf, A, Peth, J, König, H-H & Schulz, H 2020, 'Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER)', BMJ OPEN, Jg. 10, Nr. 5, 10, S. e036021. https://doi.org/10.1136/bmjopen-2019-036021

APA

Lambert, M., Karow, A., Gallinat, J., Lüdecke, D., Kraft, V., Rohenkohl, A., Schröter, R., Finter, C. S., Siem, A-K. H-L., Tlach, L., Werkle, N., Bargel, S., Ohm, G., Hoff, M., Peter, H., Scherer, M., Mews, C., Pruskil, S., Lüke, J., ... Schulz, H. (2020). Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). BMJ OPEN, 10(5), e036021. [10]. https://doi.org/10.1136/bmjopen-2019-036021

Vancouver

Lambert M, Karow A, Gallinat J, Lüdecke D, Kraft V, Rohenkohl A et al. Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). BMJ OPEN. 2020 Mai 4;10(5):e036021. 10. https://doi.org/10.1136/bmjopen-2019-036021

Bibtex

@article{9d1cea9ae03747f8a1a8eb8141a84e85,
title = "Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER)",
abstract = "INTRODUCTION: Healthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, assertive community treatment) and therapies (eg, psychotherapy). The study rationale is the investigation of the effectiveness and efficiency of stepped and integrated care in comparison to standard care.METHODS AND ANALYSIS: The trial is conducted in accordance to the Standard Protocol Items: Recommendations for Interventional Trials Statement. The study aims to compare the RECOVER model with treatment as usual (TAU). The following questions are examined: Does RECOVER reduce healthcare costs compared with TAU? Does RECOVER improve patient-relevant outcomes? Is RECOVER cost-effective compared with TAU? A total sample of 890 patients with mental disorders will be assessed at baseline and individually randomised into RECOVER or TAU. Follow-up assessments are conducted after 6 and 12 months. As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured. In addition, several secondary outcomes will be assessed. Primary and secondary outcomes are evaluated according to the intention-to-treat principle. Mixed linear or logistic regression models are used with the direct maximum likelihood estimation procedure which results in unbiassed estimators under the missing-at-random assumption. Costs due to healthcare utilisation and productivity losses are evaluated using difference-in-difference regressions.ETHICS AND DISSEMINATION: Ethical approval from the ethics committee of the Hamburg Medical Association has been obtained (PV5672). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.TRIAL REGISTRATION NUMBER AND REGISTRY NAME: ClinicalTrials.gov (NCT03459664), RECOVER PROTOCOL VERSION: 19 March 2020 (V.3.0).",
keywords = "adult psychiatry, child & adolescent psychiatry, health economics, organisation of health services, protocols & guidelines",
author = "Martin Lambert and Anne Karow and J{\"u}rgen Gallinat and Daniel L{\"u}decke and Vivien Kraft and Anja Rohenkohl and Romy Schr{\"o}ter and Finter, {Constanze Sophia} and Siem, {Anna-Katharina Huei-Ling} and Lisa Tlach and Nathalie Werkle and Susann Bargel and Gunda Ohm and Martin Hoff and Helmut Peter and Martin Scherer and Claudia Mews and Susanne Pruskil and Johannes L{\"u}ke and Martin H{\"a}rter and J{\"o}rg Dirmaier and Michael Schulte-Markwort and Bernd L{\"o}we and Peer Briken and Heike Peper and Michael Schweiger and Mike-Oliver M{\"o}sko and Thomas Bock and Martin Wittzack and Hans-Jochim Meyer and Arno Deister and Rolf Michels and Stephanie Herr and Alexander Konnopka and Hannah K{\"o}nig and Karl Wegscheider and Anne Daubmann and Antonia Zapf and Judith Peth and Hans-Helmut K{\"o}nig and Holger Schulz",
note = "{\textcopyright} Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2020",
month = may,
day = "4",
doi = "10.1136/bmjopen-2019-036021",
language = "English",
volume = "10",
pages = "e036021",
journal = "BMJ OPEN",
issn = "2044-6055",
publisher = "British Medical Journal Publishing Group",
number = "5",

}

RIS

TY - JOUR

T1 - Study protocol for a randomised controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER)

AU - Lambert, Martin

AU - Karow, Anne

AU - Gallinat, Jürgen

AU - Lüdecke, Daniel

AU - Kraft, Vivien

AU - Rohenkohl, Anja

AU - Schröter, Romy

AU - Finter, Constanze Sophia

AU - Siem, Anna-Katharina Huei-Ling

AU - Tlach, Lisa

AU - Werkle, Nathalie

AU - Bargel, Susann

AU - Ohm, Gunda

AU - Hoff, Martin

AU - Peter, Helmut

AU - Scherer, Martin

AU - Mews, Claudia

AU - Pruskil, Susanne

AU - Lüke, Johannes

AU - Härter, Martin

AU - Dirmaier, Jörg

AU - Schulte-Markwort, Michael

AU - Löwe, Bernd

AU - Briken, Peer

AU - Peper, Heike

AU - Schweiger, Michael

AU - Mösko, Mike-Oliver

AU - Bock, Thomas

AU - Wittzack, Martin

AU - Meyer, Hans-Jochim

AU - Deister, Arno

AU - Michels, Rolf

AU - Herr, Stephanie

AU - Konnopka, Alexander

AU - König, Hannah

AU - Wegscheider, Karl

AU - Daubmann, Anne

AU - Zapf, Antonia

AU - Peth, Judith

AU - König, Hans-Helmut

AU - Schulz, Holger

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2020/5/4

Y1 - 2020/5/4

N2 - INTRODUCTION: Healthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, assertive community treatment) and therapies (eg, psychotherapy). The study rationale is the investigation of the effectiveness and efficiency of stepped and integrated care in comparison to standard care.METHODS AND ANALYSIS: The trial is conducted in accordance to the Standard Protocol Items: Recommendations for Interventional Trials Statement. The study aims to compare the RECOVER model with treatment as usual (TAU). The following questions are examined: Does RECOVER reduce healthcare costs compared with TAU? Does RECOVER improve patient-relevant outcomes? Is RECOVER cost-effective compared with TAU? A total sample of 890 patients with mental disorders will be assessed at baseline and individually randomised into RECOVER or TAU. Follow-up assessments are conducted after 6 and 12 months. As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured. In addition, several secondary outcomes will be assessed. Primary and secondary outcomes are evaluated according to the intention-to-treat principle. Mixed linear or logistic regression models are used with the direct maximum likelihood estimation procedure which results in unbiassed estimators under the missing-at-random assumption. Costs due to healthcare utilisation and productivity losses are evaluated using difference-in-difference regressions.ETHICS AND DISSEMINATION: Ethical approval from the ethics committee of the Hamburg Medical Association has been obtained (PV5672). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.TRIAL REGISTRATION NUMBER AND REGISTRY NAME: ClinicalTrials.gov (NCT03459664), RECOVER PROTOCOL VERSION: 19 March 2020 (V.3.0).

AB - INTRODUCTION: Healthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, assertive community treatment) and therapies (eg, psychotherapy). The study rationale is the investigation of the effectiveness and efficiency of stepped and integrated care in comparison to standard care.METHODS AND ANALYSIS: The trial is conducted in accordance to the Standard Protocol Items: Recommendations for Interventional Trials Statement. The study aims to compare the RECOVER model with treatment as usual (TAU). The following questions are examined: Does RECOVER reduce healthcare costs compared with TAU? Does RECOVER improve patient-relevant outcomes? Is RECOVER cost-effective compared with TAU? A total sample of 890 patients with mental disorders will be assessed at baseline and individually randomised into RECOVER or TAU. Follow-up assessments are conducted after 6 and 12 months. As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured. In addition, several secondary outcomes will be assessed. Primary and secondary outcomes are evaluated according to the intention-to-treat principle. Mixed linear or logistic regression models are used with the direct maximum likelihood estimation procedure which results in unbiassed estimators under the missing-at-random assumption. Costs due to healthcare utilisation and productivity losses are evaluated using difference-in-difference regressions.ETHICS AND DISSEMINATION: Ethical approval from the ethics committee of the Hamburg Medical Association has been obtained (PV5672). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.TRIAL REGISTRATION NUMBER AND REGISTRY NAME: ClinicalTrials.gov (NCT03459664), RECOVER PROTOCOL VERSION: 19 March 2020 (V.3.0).

KW - adult psychiatry

KW - child & adolescent psychiatry

KW - health economics

KW - organisation of health services

KW - protocols & guidelines

UR - http://www.scopus.com/inward/record.url?scp=85084327357&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2019-036021

DO - 10.1136/bmjopen-2019-036021

M3 - SCORING: Journal article

C2 - 32371520

VL - 10

SP - e036021

JO - BMJ OPEN

JF - BMJ OPEN

SN - 2044-6055

IS - 5

M1 - 10

ER -