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
Creators: name: Knauer, Johannes
name: Terhorst, Yannik
name: Philippi, Paula
name: Krallinger, Selina
name: Eiler, Sandro
name: Kilian, Reinhold
name: Waldmann, Tamara
name: Moshagen, Morten
name: Bader, Martina
Publisher: name: Universität Ulm
Year: 2022
Subjects: subject: Health economics
subject: Health informatics
subject: Rehabilitation medicine
subject: DDC 610 / Medicine &amp; health
subject: Medical economics
subject: Mental health
subject: Primary health care
subject: Economics, Medical
subject: Medical informatics
subject: Mental disorders; Diagnosis
subject: Psychische Gesundheit
subject: Psychiatrie
subject: Primäre Gesundheitsversorgung
subject: Gesundheitsökonomie
subject: Medizinische Informatik

description: 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.