RESUMO
PURPOSE: Non-specific low back pain (NLBP) causes an enormous burden to patients and tremendous costs for health care systems worldwide. Frequently, treatments are not oriented to existing guidelines. In the future, digital elements may be promising tools to support guideline-oriented treatment in a broader range of patients. The cluster-randomized controlled "Rise-uP" trial aims to support a General Practitioner (GP)-centered back pain treatment (Registration No: DRKS00015048) and includes the following 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 of chronic back pain, and 4) a multidisciplinary mobile back pain app for all patients (Kaia App). METHODS: In the Rise-uP trial, 111 GPs throughout Bavaria (southern Germany) 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 rating on the numeric rating scale was the primary outcome measure. Psychological measures (anxiety, depression, stress), functional ability, as well as physical and mental wellbeing, served as secondary outcomes. All values were assessed at the beginning of the treatment and at 3-month follow-ups. RESULTS: In total, 1245 patients (IG: 933; CG: 312) with NLBP were included in the study. The Rise-uP group showed a significantly stronger pain reduction compared to the control group after 3 months (IG: M=-33.3% vs CG: M=-14.3%). The Rise-uP group was also superior in secondary outcomes. Furthermore, high-risk patients who received a teleconsultation showed a larger decrease in pain intensity (-43.5%) than CG patients (-14.3%). ANCOVA analysis showed that the impact of teleconsultation was mediated by an increased training activity in the Kaia App. CONCLUSION: Our results show the superiority of the innovative digital treatment algorithm realized in Rise-uP, even though the CG also received relevant active treatment by their GPs. This provides clear evidence that digital treatment may be a promising tool to improve the quality of treatment of non-specific back pain. In 2021, analyses of routine data from statutory health insurances will enable us to investigate the cost-effectiveness of digital treatment.
RESUMO
Patient care is a complex process with different providers located in various institutions co-operating within an integrated health environment. In spite of technical improvements in medical care, patient information is usually exchanged by paper. Digital and timely communication between regional care providers can improve the exchange of information. Different systems and missing data standards are challenges that have to be met. ByMedConnect, a project sponsored by the Bavarian State Ministry of the Environment and Public Health, develops and demonstrates a communication solution based on the EN 13606 standard. In a first step the dataset, which will be exchanged by the care providers, is defined. ByMedConnect develops the dataset in cooperation with practicing clinicians and converts it via modeling tools into archetypes that provide the base for reliable cross-sector communication. Existing heterogeneous systems are integrated via a dedicated module that transforms legacy data into a normalized representation. Information provided in a standardized form thereby enables semantic interoperability between different systems and allows medical add-on applications to connect. A secure digital communication network guarantees easy and direct data sharing. ByMedConnect aims to evaluate the achieved theoretical preliminary work in practice and to draft approaches, which can be applied beyond the pilot application.
