SMILe, SteM cell transplantatIon faciLitated by eHealth

Background
Allogeneic stem cell transplantation (alloSCT) offers a curative treatment for various hematological diseases like acute leukemia and aplastic anemia. Significant advancements have increased the number of transplants and long-term survivors, but they face challenges including early complications, infections, GvHD, and psychosocial issues like fatigue and depression. Integrated care, self-management, and eHealth innovations are recommended, yet real-world implementation remains challenging.

Overall aim
The overall aim of the SMILe project is the development/adaptation, implementation and testing of an Integrated Care Model (ICM) for SteM cell transplantatIon faciLitated by eHealth (SMILe-ICM) by combining implementation-, behavioral- and computer science methods.

Methods
To reach our overall aim, we followed two Phases:
Phase A (i.e. contextual analysis, intervention development/adaptation, choice of implementation strategies): The Basel Approach for Contextual ANAlysis (BANANA) guided the SMILe contextual analysis to inform SMILe-ICM’s development, adaptation and setting-specific implementation strategies (e.g. revise professional roles). We applied a mixed-methods design and ongoing stakeholder engagement by assessing quantitative (i.e., survey) and qualitative (i.e., interviews/focus groups). Based on the results of Phase A, we developed and adapted the SMILe-ICM.

The SMILe–ICM is the first theory-based comprehensive eHealth-facilitated ICM for the first year after alloSCT. Developed by marrying different methodological approaches, SMILe–ICM includes four intervention modules (i.e., monitoring & follow-up of symptoms and medical parameters, medication adherence, infection prevention, physical activity). It combines human and technology components. The human components were delivered by a newly implemented Advanced Practice Nurses (APNs) team, embedded in the multiprofessional alloSCT team. The technology component (i.e., the SMILeApp) allows to monitor patients’ symptoms and health behaviors remotely and transfers data to the APNs in the center. Alongside, patients receive 12 personal visits to systematically foster their self-management. Alongside the alloSCT team, the APN manages complications based on care algorithms. Thus, SMILe–ICM targets alloSCT patients’ clinical and behavioral short- (e.g., infections) and medium-term outcomes (e.g., adherence, treatment burden, GVHD).

Phase B: Using a hybrid effectiveness-implementation randomized controlled trial evaluated the effectiveness of the SMILe-ICM at two European alloSCT centers (Freiburg, Germany & Basel, Switzerland).
We included a consecutive sample of 72, respectively 80 adult alloSCT patients who were transplanted and followed-up by the centers. Patient-level (1:1) stratified randomization into a usual care group and a SMILe-ICM group took place 10 days pre-transplantation. To gauge the SMILe–ICM’s effectiveness primary outcome (costs/re-hospitalization rate), secondary outcomes (healthcare utilization costs; length of inpatient re-hospitalizations, medication adherence; treatment and self-management burden; HRQoL; Graft-versus-Host Disease rate; survival; overall survival rate) and implementation outcomes (acceptability, appropriateness, feasibility, fidelity), we have applied multi-method, multi-informant assessment (questionnaires, interviews, health record data).

Conclusion
Our innovative combination of different methodologies supported the context specific development/adaptation & implementation. Preliminary key results reveal a signal for favorable implementation and effectiveness outcomes and can be a blueprint for further settings/populations (e.g., pediatrics). A following in-depth process evaluation will inform how intervention, context & implementation strategies have contributed to the outcomes. The SMILe-ICM has already been sustained in the first center and a new module is currently under development (i.e. for chronic GvHD patients).