Innovative Evaluation Methods for Integrated Care Projects: The GerOnTe Project

Introduction: Despite the global increase in multimorbid patients, evaluating complex interventions for multimorbid patients faces numerous challenges. These include the underrepresentation of older patients in randomized controlled trials (RCTs), a scarcity of robust economic evaluations, a lack of validated quality key performance indicators (QKPIs), insufficient analyses of healthcare system characteristics impacting multimorbidity care delivery, and limited formal evaluations of health technology projects. This contribution aims to discuss these challenges and highlight the unique approach to evaluating integrated care projects developed by the GERONTE Project. The GERONTE Project, a 5-year initiative funded by the European Union under the H2020 Research and Innovation program, seeks to enhance the quality of life for older multimorbid patients while reducing overall care costs. The GERONTE intervention integrates care from various healthcare professionals into a novel pathway coordinated by an Advanced Practice Nurse (APN) as the case manager and facilitated by data sharing with an ICT Tool, integrating medical and patient-reported data for informed decision-making. Methods: The GERONTE study comprises two stepped-wedge trials conducted at 16 clinical sites across France, Belgium, and the Netherlands. The primary study includes 1440 patients aged 70 and over with new or progressive cancer and at least one moderate or severe multimorbidity. The intervention group receives the new care pathway, while the control group receives standard oncologic care. The study duration is approximately 30 months, with 18 months of active enrollment. Primary and secondary objectives include evaluating the effectiveness of the GERONTE ICT-based integrated care pathway, assessing cost-utility, and exploring caregiver burden, among other outcomes.In addition to the primary study, an ancillary study explores the implementation journey, focusing on the current care pathways for older multimorbid patients before GERONTE implementation. This study aims to develop a comprehensive implementation guide for GERONTE across diverse settings. Results: The GerOnTe intervention introduces innovative elements addressing challenges in healthcare delivery for older multimorbid patients. The study's primary innovation lies in its comprehensive evaluation approach, combining two stepped-wedge trials, bottom-up economic evaluation, and realist evaluation methods. A citizen science approach involving healthcare professionals, management experts, patients, and informal caregivers enhances the co-design process. GerOnTe will develop a dashboard of quality key performance indicators for monitoring care pathways. This includes approximately 15-30 indicators targeting the goals of GerOnTe and the needs of older multimorbid patients. The study, one of the largest realist evaluations of e-health implementation, combines traditional trial approaches with a detailed mixed-methods study, providing valuable insights across different healthcare systems. Conclusion: The GerOnTe project acknowledges the varying configurations of healthcare systems across countries, emphasizing the importance of context in care delivery. The integration of diverse evaluation methods, along with the creation of an implementation guide and business plan, aims to facilitate the wider dissemination and adoption of the GerOnTe model in diverse healthcare settings. The study's findings have the potential to advance integrated care for older patients and inform future innovations in healthcare delivery on a broader scale.