Evaluation eines frühen interdisziplinären multimodalen Assessments für Patienten mit Schmerzen: Protokoll einer randomisierten kontrollierten Studie (PAIN2020)

Health care provision for patients with pain and risk factors for chronicity is still insufficient and characterized in particular by over-, under- and misuse of existing approaches. The PAIN2020 project is funded by the German Federal Ministry of Health Care (Innovationsfonds 01NVF17049) and aims to improve health care delivery for this group of patients by implementing an early ambulatory diagnostic approach by a pain specialist, resulting in an improvement in pain and restored or maintained function. A randomized clinical trial in 31 facilities Germany-wide will identify eligible patients and guide them into early specialized pain diagnostics. The interventional arm provides an interdisciplinary multimodal assessment, delivered by pain medicine specialists, physiotherapists and clinical psychologists. The control arm contains a single assessment by a pain specialist. Patients and caregivers receive detailed recommendations for evidence-based interventions tailored to the needs of the individual patient. Two evaluation approaches will be merged. The first requires a net sample size of 3840 patients, assessed (admission) and followed-up (3 and 6 months) by clinical data (German Pain Questionnaire, additional scales) and analyzed by a multi-level approach. In a second evaluation arm the clinical data of the included patients will be supplemented by secondary data from a statutory health insurance (BARMER) and compared to a sample of policyholders not addressed by the study. Data analyses will be performed by an external evaluation institute. The project started in April 2018.