Implementation and Testing of an eHealth Integrated Model of Care for Patients Receiving Allogeneic Stem Cell Transplantation: The SMILe Project

Numerous publications call for innovation based on integrated care principles, investment in self-management and use of eHealth to improve outcomes for allogeneic Stem Cell Transplant (alloSCT). While eHealth supported integrated care models are effective, real-world implementation remain elusive. The newly developed SMILe-Integrated Care Model (ICM) is the first theory-based eHealth supported integrated care model for alloSCT patients. SMILe-ICM includes four self-management modules (i.e., monitoring \& follow-up, medication adherence, infection prevention, physical activity) and combines a human role, i.e., a Care Coordinator (CC), with a technological component (i.e., the SMILeApp). Patients monitor and transfer symptoms and health behaviours to their CC, who supports them in self-management and dealing with complications. Embedded in implementation science methodology, we aim to implement and test the SMILe-ICM at the University Hospital Basel (USB) in the first year post-alloSCT by evaluating effectiveness, implementation outcomes and implementation pathway. A hybrid 1 effectiveness-implementation randomized controlled trial will include 80 adult alloSCT patients who are transplanted and followed up at USB, have basic German proficiency and provide written informed consent. Patients with physical or mental conditions limiting the use of the SMILeApp will be excluded. About ten days before alloSCT, a stratified randomization based on participants' clinical risk scores will assign patients 1:1 to the control (CG) or intervention group (IG). The CG will receive usual care; the IG will receive the SMILe-ICM over one year with 12 CC visits and continuous use of the SMILeApp. Re-hospitalization rate (primary outcome), total healthcare utilization costs, acute and chronic GvHD episodes and survival will be assessed using medical records. Medication adherence will be assessed via the BAASIS© scale, treatment burden via the PETS©, health-related quality of life via t