Protocol of the interdisciplinary and intersectoral randomized controlled trial in Parkinson patients in a specialized network in Germany: the INSPIRE Trial

INSPIRE-PNRM+ (short for InterdiSciPlinary and InteRsectoral telemedIcal Evaluation, Coordination and Therapy at the ParkinsonNet RheinMain+) is an one-year, multicentre, interventional, open-label, two-arm, 1:1 randomized controlled trial (RCT) with the goal to improve the quality of care for Parkinson’s disease (PD) patients outside of a specialized clinical context. The study is funded by the German Innovation Fund mandated by the Federal Joint Committee (G-BA). The three core characteristics are (1) the employment of specially trained advanced practice nurses (APN) in an (2) interdisciplinary network and (3) the use of a specifically designed digital platform. This platform serves for documentation and communication, thereby helping patients receive individualized, guideline-based treatment and support in adapting their lives to the effects of the disease. 844 patients will be recruited. They will be divided into two groups: a “usual care” group which continues traditional care (i.e., usually consultation with a neurologist in private practice) vs. the “intervention” group which will have APN contact every three months or more frequently as needed over the period of 12 months. Patients’ quality of life serves as primary outcome measure, combined with a process evaluation and health economic analysis (cost-utility analysis (CUA)). Recruitment was ongoing at time of submission of this paper. This innovative study is the first in Germany where APNs are dedicated to PD care. The study may serve as blueprint when incorporating APNs into routine healthcare, similar to other countries. TRIAL REGISTRATION: The study has been registered at www.clinicaltrials.gov , NCT06479083. Registered June 27, 2024. https://clinicaltrials.gov/study/NCT06479083?term=INSPIRE%20Parkinson&rank=1 .