The PRIME-NL study: evaluating a complex healthcare intervention for people with Parkinson’s disease in a dynamic environment
Bart R. Maas,
Robin van den Bergh,
Sanne W. van den Berg,
Eveline Hulstein,
Niek Stadhouders,
Patrick P.T. Jeurissen,
Nienke M. de Vries,
Bastiaan R. Bloem,
Marten Munneke,
Yoav Ben-Shlomo,
Sirwan K.L. Darweesh
Affiliations
Bart R. Maas
Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Radboud university medical center
Robin van den Bergh
Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Radboud university medical center
Sanne W. van den Berg
Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Radboud university medical center
Eveline Hulstein
Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Radboud university medical center
Niek Stadhouders
IQ Health, Radboud University Medical Center, Radboud Institute for Health Sciences
Patrick P.T. Jeurissen
IQ Health, Radboud University Medical Center, Radboud Institute for Health Sciences
Nienke M. de Vries
Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Radboud university medical center
Bastiaan R. Bloem
Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Radboud university medical center
Marten Munneke
Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Radboud university medical center
Yoav Ben-Shlomo
Population Health Sciences, Bristol Medical School, University of Bristol
Sirwan K.L. Darweesh
Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson and Movement Disorders, Radboud university medical center
Abstract Background An innovative, integrative care model for people with Parkinson (PRIME Parkinson) has gradually been implemented in a selected region of the Netherlands since 2021. A prospective evaluation of this model (PRIME-NL study) was initiated in parallel, spanning the year prior to implementation (baseline) and the implementation period. Following publication of the original study protocol, the COVID-19 crisis delayed implementation of the full PRIME Parkinson care model by two years and hampered the recruitment of study participants. Objective To describe which methodological adjustments were made to the study protocol because of these developments. Methods We compare various outcomes between a region where PRIME Parkinson care was implemented (innovation region) versus the rest of the Netherlands (usual care region). We use healthcare claims data of virtually all people with Parkinson in the Netherlands and annual questionnaires in a representative subsample of 984 people with Parkinson, 566 caregivers and 192 healthcare professionals. Four major methodological adjustments had to be made since publication of the original protocol. First, we extended the evaluation period by two years. Second, we incorporated annual process measures of the stage of implementation of the new care model. Third, we introduced a real-time iterative feedback loop of interim results to relevant stakeholders. Fourth, we updated the statistical analysis plan. Discussion This manuscript provides transparency in how the design and analyses of the evaluation study had to be adapted to control for external influences in a dynamic environment, including eruption of the COVID-19 crisis. Our solutions could serve as a template for evaluating other complex healthcare interventions in a dynamic environment.
