Autor:innen:
Dr. Janosch A. Priebe | Klinikum rechts der Isar (MRI), Technical University of Munich, Munich, Germany | Germany
Dr. Linda Kerkemeyer | inav GmbH, Berlin, Germany | Germany
Katharina K Haas | Klinikum rechts der Isar (MRI), Technical University of Munich, Munich, Germany | Germany
Katharina Achtert | inav GmbH, Berlin, Germany | Germany
Leida Fernanda Moreno Sanchez | Klinikum rechts der Isar (MRI), Technical University of Munich, Munich, Germany | Germany
Paul Stockert | Klinikum rechts der Isar (MRI), Technical University of Munich, Munich, Germany | Germany
Philipp Schuster | Klinikum rechts der Isar (MRI), Technical University of Munich, Munich, Germany | Germany
Dr. Reinhard Thoma | Algesiologikum Pain Center | Germany
Prof. Dr. Siegfried Jedamzik | Bayerische TelemedAllianz (BTA) | Germany
Jan Reichmann | StatConsult GmbH Magdeburg | Germany
Dr. Sebastian Franke | Technical University of Munich (TUM), Munich, Germany | Germany
Prof. Dr. Leonie Sundmacher | Technical University of Munich (TUM), Munich, Germany | Germany
Dr. med. Ursula Marschall | Barmer Hauptverwaltung | Germany
Sophie Schwab | DAK Landesvertretung Bayern, Munich, Germany | Germany
Margit Hermann | AOK Bayern, Munich, Germany | Germany
Prof. Dr. Volker Amelung | inav GmbH, Berlin, Germany | Germany
Prof. Dr. Thomas R. Toelle | Klinikum rechts der Isar (MRI), Technical University of Munich, Munich, Germany | Germany
Background: Non-specific low back pain (NLBP) causes an enormous burden to patients and tremendous costs for health care systems worldwide. Often treatments are not oriented to guidelines and about 65% of patients with acute or subacute NLBP still report pain after 12 months. The cluster-randomized controlled Rise-uP trial, funded by Innovationsfonds Germany, established a GP centered back pain treatment with four digital elements: (1) electronic case report form (eCRF), (2) a treatment algorithm for guideline-based clinical decision making of GPs, (3) teleconsultation between GPs and pain specialists for patients at risk for development chronic back pain, and (4) the multidisciplinary Kaia back pain app. Here we present the long-term results of the Rise-uP trial (12 months follow-up) which refer to (1) patient-reported outcome measures (PROMs) and (2) the health-care costs.
Methods: 111 GPs throughout Bavaria were randomized either to the Rise-uP intervention group (IG) or the control group (CG). Rise-uP patients were treated according to the guideline-oriented Rise-uP treatment algorithm. Standard of care was applied to the CG patients with consideration given to the “National guideline for the treatment of non-specific back pain”. Pain ratings (primary outcome) as well as psychological measures (anxiety, depression, stress), functional ability and physical and mental wellbeing (secondary outcomes) were assessed at the beginning of the treatment and at a 3-, 6- and 12 months follow-up. Furthermore, individual healtcare cost data provided by the health insurances AOK, DAK and BARMER were analyzed and compared between groups.
Results: In total, 1245 patients (IG: 933; CG: 312) with NLBP were included into the study. The Rise-uP group showed a significant stronger pain reduction compared to the control group after 12 months (IG: -46% vs. CG: -24%; p < .001). The Rise-uP group was also superior in secondary outcomes (stress, anxiety, depression, functional ability and wellbeing).
Cost analyses showed cost-differences of -80% in favour of Rise-uP (difference-in-difference analysis). While healthcare costs in the control group increased by +208 € on average during the observational period, the costs in the Rise-uP group were reduced on average by -39 €, which is a significant difference-in-difference (DID) = 247 € (p = .011). The cost-effectiveness analysis showed cost savings of 312 € per point reduction on the NRS pain scale.
Conclusions: Our results show clinical and economic superiority of the innovative digital treatment algorithm realized in Rise-uP in a long-term observation period of one year, even though the control group also received active treatment by their GPs. The Rise-uP trial provides clear evidence that digital treatment is a promising tool to sustainably improve the outcome of NLBP treatment and - at the same time - to save costs. Thus, digital treatment shows potential to contribute to standard-of-care in back pain.