Clinical effectiveness of patient-targeted feedback following depression screening in general practice (GET.FEEDBACK.GP): an investigator-initiated, prospective, multicentre, three-arm, observer-blinded, randomised controlled trial in Germany - PubMed (original) (raw)
Randomized Controlled Trial
. 2024 Apr;11(4):262-273.
doi: 10.1016/S2215-0366(24)00035-X. Epub 2024 Feb 29.
Martin Scherer 2, Lea-Elena Braunschneider 3, Gabriella Marx 2, Marion Eisele 2, Tina Mallon 2, Antonius Schneider 4, Klaus Linde 4, Christine Allwang 5, Stefanie Joos 6, Stephan Zipfel 7, Sven Schulz 8, Liliana Rost 8, Katja Brenk-Franz 9, Joachim Szecsenyi 10, Christoph Nikendei 11, Martin Härter 12, Jürgen Gallinat 13, Hans-Helmut König 14, Alexander Fierenz 15, Eik Vettorazzi 15, Antonia Zapf 15, Marco Lehmann 3, Sebastian Kohlmann 3
Affiliations
- PMID: 38432236
- DOI: 10.1016/S2215-0366(24)00035-X
Free article
Randomized Controlled Trial
Clinical effectiveness of patient-targeted feedback following depression screening in general practice (GET.FEEDBACK.GP): an investigator-initiated, prospective, multicentre, three-arm, observer-blinded, randomised controlled trial in Germany
Bernd Löwe et al. Lancet Psychiatry. 2024 Apr.
Free article
Abstract
Background: Screening for depression in primary care alone is not sufficient to improve clinical outcomes. However, targeted feedback of the screening results to patients might result in beneficial effects. The GET.FEEDBACK.GP trial investigated whether targeted feedback of the depression screening result to patients, in addition to feedback to general practitioners (GPs), leads to greater reductions in depression severity than GP feedback alone or no feedback.
Methods: The GET.FEEDBACK.GP trial was an investigator-initiated, multicentre, three-arm, observer-blinded, randomised controlled trial. Depression screening was conducted electronically using the Patient Health Questionnaire-9 (PHQ-9) in 64 GP practices across five regions in Germany while patients were waiting to see their GP. Currently undiagnosed patients (aged ≥18 years) who screened positive for depression (PHQ-9 score ≥10), were proficient in the German language, and had a personal consultation with a GP were randomly assigned (1:1:1) into a group that received no feedback on their depression screening result, a group in which only the GP received feedback, or a group in which both GP and patient received feedback. Randomisation was stratified by treating GP and PHQ-9 depression severity. Trial staff were masked to patient enrolment and study group allocation and GPs were masked to the feedback recieved by the patient. Written feedback, including the screening result and information on depression, was provided to the relevant groups before the consultation. The primary outcome was PHQ-9-measured depression severity at 6 months after randomisation. An intention-to-treat analysis was conducted for patients who had at least one follow-up visit. This study is registered at ClinicalTrials.gov (NCT03988985) and is complete.
Findings: Between July 17, 2019, and Jan 31, 2022, 25 279 patients were approached for eligibility screening, 17 150 were excluded, and 8129 patients completed screening, of whom 1030 (12·7%) screened positive for depression. 344 patients were randomly assigned to receive no feedback, 344 were assigned to receive GP-targeted feedback, and 339 were assigned to receive GP-targeted plus patient-targeted feedback. 252 (73%) patients in the no feedback group, 252 (73%) in the GP-targeted feedback group, and 256 (76%) in the GP-targeted and patient-targeted feedback group were included in the analysis of the primary outcome at 6 months, which reflected a follow-up rate of 74%. Gender was reported as female by 637 (62·1%) of 1025 participants, male by 384 (37·5%), and diverse by four (0·4%). 169 (16%) of 1026 patients with available migration data had a migration background. Mean age was 39·5 years (SD 15·2). PHQ-9 scores improved for each group between baseline and 6 months by -4·15 (95% CI -4·99 to -3·30) in the no feedback group, -4·19 (-5·04 to -3·33) in the GP feedback group, and -4·91 (-5·76 to -4·07) in the GP plus patient feedback group, with no significant difference between the three groups (global p=0·13). The difference in PHQ-9 scores when comparing the GP plus patient feedback group with the no feedback group was -0·77 (-1·60 to 0·07, d=-0·16) and when comparing with the GP-only feedback group was -0·73 (-1·56 to 0·11, d=-0·15). No increase in suicidality was observed as an adverse event in either group.
Interpretation: Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or no feedback. Further research is required to investigate the potential specific effectiveness of depression screening with systematic feedback for selected subgroups.
Funding: German Innovation Fund.
Translation: For the German translation of the abstract see Supplementary Materials section.
Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.
Conflict of interest statement
Declaration of interests BL reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, the European Commission Horizon 2020 Framework Programme, the European Joint Programme for Rare Diseases, the Ministry of Science, Research and Equality of the Free and Hanseatic City of Hamburg, Germany, and the Foundation Psychosomatics of Spinal Diseases, Stuttgart, Germany. He has received remuneration for several scientific book articles from various book publishers and as a committee member from Aarhus University, Denmark. He received travel expenses from the European Association of Psychosomatic Medicine (EAPM) and accommodation and meals from the Societatea de Medicina Biopsyhosociala, Romania, for a presentation at the EAPM Academy at the Conferința Națională de Psihosomatică (Cluj-Napoca, Romania; October, 2023). He was a board member of the EAPM (unpaid) until 2022. MS reports research funding (no personal honoraria) from the German Innovation Committee at the Joint Federal Committee. He is President of the German College of General Practitioners. GM reports research funding (no personal honoraria) from the German Innovation Committee at the Joint Federal Committee. She has received remuneration for a book chapter from Elsevier and for a lecture from the Forum Palliativmedizin. ME reports research funding (no personal honoraria) from the German Innovation Committee at the Joint Federal Committee and the Deutsche Alzheimer Gesellschaft e.V. Selbsthilfe Demenz. She has received remuneration for a scholarly book chapter from Elsevier. AS reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, and the German Innovation Committee at the Joint Federal Committee. He has received remuneration for a scholarly book chapter from Elsevier. KL reports research funding (no personal honoraria) from the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, and the Technische Universität München, TUM School of Medicine and the Bavarian Ministry for Science and Art, Munich, Germany. CA reports research funding (no personal honoraria) from the German Federal Ministry of Education and Research. SJ reports research funding (no personal honouraria) from the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, the German Federal Ministry of Health, and the AOK Statutory Health Insurance Baden-Württemberg. She has received remuneration for a scholarly book chapter from Thieme and as a member of the Data and Safety Monitoring Board for a study carried out at the Department of Naturopathy (Charité, Berlin, Germany). She is a member of an expert council on health and care of the German Federal Ministry of Health. SZ is President-elect of the International College of Psychosomatic Medicine. He is a member of the editorial board of The Lancet Psychiatry. SS reports research funding (no personal honouraria) from the Central Institute of the Association of Statutory Health Insurance Physicians in Germany (Zentralinstitut für die kassenärztliche Versorgung). He has received remuneration for a book chapter from Thieme. KB-F reports research funding (no personal honoraria) from the German Research Foundation and the German Federal Ministry of Education and Research. CN reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, the Ministry of Science and Art Baden-Württemberg (Germany), the German Federal Ministry of Health, and the Köhler Research Fund (Germany). He has received remuneration for several scientific book articles from various book publishers. MH reports research funding (no personal honoraria) from the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, and the DAK Gesundheit (Germany; health insurance fund). He has received remuneration for several scientific book articles from various book publishers and consulting fees from the Agency for Quality in Medicine (Berlin, Germany). He has received honoraria for lectures and presentations from the Techniker Krankenkasse (Germany), the Kanton Basel CH, the Polish Institute for Evidence-based Medicine, the Klinik Münsterlingen, and the University of Lübeck (Germany). He has received payment for expert testimony from the Institute of Regional Health Research, University of Southern Denmark. As a member of the Executive Board, he has received congress fees and travel expenses to the 22nd Congress of Health Services Research 2023 from the German Network of Health Services Research, and he has received travel costs from the German Cancer Society to attend their meeting. He was Chief Executive of the German Network for Health Services Research (unpaid), Past President of the German Society of Medical Psychology (unpaid), and previous President of the International Shared Decision Making Society (unpaid). JG reports research funding (no personal honoraria) from the German Research Foundation and the German Federal Ministry of Education and Research. He has received remuneration for a scholarly book from Elsevier. He has received honoraria for lectures and presentations from Lundbeck, Janssen-Ciag, and Boehringer. H-HK reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, the European Commission Horizon 2020 Framework Programme, the European Union, and the Zentralinstitut für die kassenärztliche Versorgung (Germany). AF reports research funding (no personal honoraria) from the German Research Foundation and the German Innovation Committee at the Joint Federal Committee. EV reports research funding (no personal honoraria) from the German Research Foundation and the German Innovation Committee at the Joint Federal Committee. AZ reports research funding (no personal honoraria) from the German Research Foundation and the German Innovation Committee at the Joint Federal Committee. ML is an employee of Oviva, Germany. SK reports research funding (no personal honoraria) from the German Research Foundation and the German Federal Ministry of Education and Research. All other authors report no competing interests.
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