Article Text

Protocol
Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities
  1. Johannes Knauer1,
  2. Yannik Terhorst1,
  3. Paula Philippi1,
  4. Selina Kallinger1,
  5. Sandro Eiler1,
  6. Reinhold Kilian2,
  7. Tamara Waldmann2,
  8. Morten Moshagen3,
  9. Martina Bader3,
  10. Harald Baumeister1
  1. 1Department of Clinical Psychology and Psychotherapy, Ulm University, Ulm, Germany
  2. 2Department of Psychiatry and Psychotherapy II, Ulm University, Ulm, Germany
  3. 3Department of Psychological Research Methods, Ulm University, Ulm, Germany
  1. Correspondence to Johannes Knauer; johannes.knauer{at}uni-ulm.de

Abstract

Introduction The integration of a web-based computer-adaptive patient-reported outcome test (CAT) platform with persuasive design optimised features including recommendations for action into routine healthcare could provide a promising way to translate reliable diagnostic results into action. This study aims to evaluate the effectiveness and cost-effectiveness of such a platform for depression and anxiety (RehaCAT+) compared with the standard diagnostic system (RehaCAT) in cardiological and orthopaedic health clinics in routine care.

Methods and analysis A two-arm, pragmatic, cluster-randomised controlled trial will be conducted. Twelve participating rehabilitation clinics in Germany will be randomly assigned to a control (RehaCAT) or experimental group (RehaCAT+) in a 1:1 design. A total sample of 1848 participants will be recruited across all clinics. The primary outcome, depression severity at 12 months follow-up (T3), will be assessed using the CAT Patient-Reported Outcome Measurement Information System Emotional Distress-Depression Item set. Secondary outcomes are depression at discharge (T1) and 6 months follow-up (T2) as well as anxiety, satisfaction with participation in social roles and activities, pain impairment, fatigue, sleep, health-related quality of life, self-efficacy, physical functioning, alcohol, personality and health economic-specific general quality of life and socioeconomic cost and benefits at T1-3. User behaviour, acceptance, facilitating and hindering factors will be assessed with semistructured qualitative interviews. Additionally, a smart sensing substudy will be conducted, with daily ecological momentary assessments and passive collection of smartphone usage variables. Data analysis will follow the intention-to-treat principle with additional per-protocol analyses. Cost-effectiveness analyses will be conducted from a societal perspective and the perspective of the statutory pension insurance.

Ethics and dissemination The study will be conducted according to the Declaration of Helsinki. The Ethics Committee of Ulm University, has approved the study (on 24 February 2021 ref. 509/20). Written informed consent will be obtained for all participants. Results will be published via peer-reviewed journals.

Trial registration number DRKS00027447

  • health informatics
  • health economics
  • mental health
  • primary care
  • rehabilitation medicine
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors HB is principle investigator of RehaCAT+. HB, RK and MM obtained funding for this study. HB, JK, YT, PP, SK, MM, MB, RK and TW contributed to the study design. HB, SE, JK, YT, PP and SK developed the platform RehaCAT(+). MM and RK contributed to the design of the effectiveness and health economic evaluation. JK drafted the manuscript. All authors contributed to the article and approved the submitted version.

  • Funding This work was supported by the Federal Ministry of Education and Research (BMBF, 01GX1901).

  • Disclaimer BMBF had no role in study design, decision to publish or preparation of this manuscript. BMBF will not be involved in data collection, analyses, decision to publish or preparation of future papers regarding this study.

  • Competing interests Authors of the manuscript were partly involved in the development of RehaCAT(+). HB has been the beneficiary of study support (third party funding) from several public funding organisations in the context of research on computer-adaptive testing and patient-reported outcome systems.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.