Development and Testing of an Integrated Model of Care in the Continuum of Allogeneic Hematopoietic SteM Cell TransplantatIon faciLitated by eHealth

Subprojekt (PhD)
Contextual analysis in implementation science (Juliane Mielke)

Sabina De Geest
Lynn Leppla

Sonja Beckmann
Sabina De Geest
Lynn Leppla
Xhuljeta Luta
Sabine Valenta

Externe Projektpartner
Hochschule Augsburg, Fakultät für Informatik, Deutschland (Alexandra Teynor)| Uniklinik Freiburg, Deutschland (Monika Engelhardt, Robert Zeiser, Monika Hasemann) | KU Leuven, Belgien (Fabienne Dobbels)

Ort der Datenerhebung
– Uniklinik Freiburg

2017 bis 2020

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) follow-up care is challenged by an increasing number of long-term survivors. Given the high risk for the occurrence for Graft versus Host Disease (GvHD) and other co-morbidities after HSCT, the HSCT setting would benefit from an Integrated Model of Care in Long-Term Follow-Up after Allogeneic Hematopoietic SteM Cell Transplantation faciLitated by eHealth Technology (SMILe). Based on the principles of chronic illness management, such a novel model of care has the potential to 1) improve the continuity of HSCT care; 2) address not only the biomedical but also the self-management and psychosocial dimensions of HSTC follow-up care; and 3) bring needed innovation to enhance clinical outcomes and increase transplant centers’ capacity. The latter has been put forward in a recent NIH report and statements by the American Society of Hematology. Before implementing an eHealth-powered model of care a good understanding of practice patterns and context of HSCT follow-up care and the level of technology openness of HSCT patients and clinicians is needed.

1. To identify practice patterns and context of HSCT follow-up care with special focus on chronic illness management and to assess technology openness of HSCT patients and clinicians in the department of hematology, oncology and stem cell transplantation Freiburg.

2. To develop a SMILe-Prototype (Integrated Model of Care in Long-Term Follow-Up after Allogeneic Hematopoietic SteM Cell TransplantatIon faciLitated by eHealth Technology- Prototype).

3. To test the SMILe-prototype in view of health care utilization (primary outcome), treatment burden, medication adherence, GvHD episodes, and survival (secondary outcomes) in the first year after HSCT.

4. To evaluate the acceptability, feasibility, adoptability and fidelity of the SMILe-prototype and to develop an implementation strategy as a basis for future implementation of the SMILe care model in other HSCT centers.

We use a Type 1 Mixed Methods Effectiveness Implementation Hybrid Design. This latter methodological approach combines evaluation of clinical effectiveness with attention for implementation strategies in order to speed the translation of research findings in clinical practice (4) consisting of the following three parts. Aim 1 and 2 use an explanatory sequential mixed method design (combination survey design & focus groups) previously developed by our research group for contextual mapping of practice patterns in view of chronic illness management (BRIGHT study) and technology assessment in end-users (PICASSO-Tx (KU Leuven)). Aim 3: After development of the SMILe prototype (theory based intervention development, user-centered design), it will be tested by an RCT design. A consecutive sample of 70 adult HSCT patients will be randomized. Outcomes will be assessed using established instruments. Data analysis will be based on principles of Intention-To-Treat (ITT) and Per-Protocol (PP) analysis. Aim 4: Information on the delivery/implementation of the SMILe-prototype in view of the acceptability, feasibility, adoptability and fidelity and implementation strategy will be assessed in all stakeholders using mixed methods.

Erwarteter Nutzen / Relevanz
HSCT care is challenged by two major issues: (1) the increase in the number of long-term survivors; and (2) the need for an integrated care model that addresses not only biomedical but also behavioral and psychosocial dimensions of HSCT care over a longer period. A recent Swiss matched control study in HSCT survivors highlighted that survivors experience problems executing several health-enhancing behaviors, warranting corrective interventions. Screening and prevention of post-transplantation late effects is recommended; yet reducing progression and occurrence of co-morbidities will depend on patients engaging in self-management behaviors–for which patients need support.

However, because of shortages of time and resources, the prevailing current HSCT follow-up systems are neither prepared nor powered for an integrated model of care. Information on variability of practice patterns in view of HSCT patients’ long-term follow-up care–especially in view of levels of chronic illness management–would be helpful to identify gaps more precisely. Moreover, reengineering the follow-up care of patients in HSCT centers using principles of chronic illness management powered by eHealth technology will very likely enhance quality of care and provide opportunities for more optimal long-term HSCT care delivery.

The SMILE project addresses both of these elements and has the potential to truly innovate the HSCT follow-up care. Indeed, the SMILe prototype, an eHealth-powered integrated care model for follow-up of patients after HSCT, introduces a new model of HSCT care. Conceptualized on the principles of Chronic Care Model, the SMILe prototype realizes a continuous feedback loop of information (e.g., linking medical parameters, symptom burden, and health behaviors) between the home health setting and the HSCT center, as well as the delivery of specific intervention bundles (e.g., support for self-management).

While this SMILe prototype is being developed for the HSCT population, it can also function and be adapted and implemented in other chronically ill populations, especially solid organ transplantation. Indeed, the SMILe prototype’s methodology and modular structure–including several intervention bundles relevant for all chronically ill groups (e.g., physical activity, medication adherence)–facilitates adaptation and subsequent implementation in a broad range of settings