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

Stem Cell Transplantation Clinical Trial

Official title: Towards Implementation of an Integrated Model of Care in Long-Term Follow-Up After Allogeneic Hematopoietic SteM Cell TransplantatIon faciLitated by eHealth Technology (The SMILe Project) - An Effectiveness-implementation Science Study

Status Active, not recruiting

Clinical Trial Summary

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 the EQ-5D-5L©. Implementation outcomes will be assessed via questionnaires and the implementation pathway via qualitative focus groups, each from patient and CC perspectives. Patients will be followed up 3 months after the intervention ended. Intention-to-treat and per-protocol analyses will be conducted using the rate ratio by unconditional maximum likelihood estimation (Wald) for the primary outcome. Qualitative data will be analysed using mind-mapping techniques and thematic analysis.

Clinical Trial Description

Background. 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), patients with complex care needs and multiple morbidities. While eHealth supported integrated care models are effective, real-world implementation and sustainability remain elusive. Combining implementation science with computer and behavioural science methods, we will implement and evaluate the newly developed SMILe-Integrated Care Model (SMILe-ICM) for alloSCT patients, aiming to reduce first year post-alloSCT re-hospitalizations.

The SMILe-ICM is the first theory-based comprehensive eHealth supported integrated care model. Developed by marrying different methodological approaches, it comprehensively addresses alloSCT needs by optimizing care coordination and care processes, and by reducing response times in cases where the patient's condition is deteriorating at home. SMILe-ICM includes four self-management care modules (i.e., monitoring & follow-up, medication adherence, infection prevention, physical activity) and combines a human role newly embedded in the SCT team, i.e., a Care Coordinator (CC), with a technological component (i.e., the SMILeApp). Patients' symptoms and health behaviours are monitored and transferred, as necessary, to their CC, who supports them in their self-management. Alongside the alloSCT team, the CC manages complications based on care algorithms. Thus, SMILe-ICM targets alloSCT patients' clinical and behavioural short- (e.g., infections) and medium-term outcomes (e.g., adherence, treatment burden, GVHD). Our SMILe-ICM pilot work indicates high-level acceptability, feasibility and technological performance.

Purpose. 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. In addition to targeting one primary outcome, re-hospitalization rate, our secondary outcomes will include effectiveness (e.g., health care costs, medication adherence) and implementation outcomes (e.g., acceptability, fidelity). We will also describe and evaluate our implementation pathway. Patients will be followed up 3 months after the end of the intervention period.

Methods. A hybrid 1 effectiveness-implementation randomized controlled trial will include 80 adult alloSCT patients from the USB Department of Haematology who are transplanted and followed up at USB, have basic German proficiency and elementary computer literacy, and who provide written informed consent. Patients with physical or mental conditions limiting their use of the SMILe-ICM's technology component will be excluded. Approximately ten days before the scheduled alloSCT, a stratified randomization (based on participants' clinical risk scores) will assign patients 1:1 to the control group (CG) or the SMILe-ICM intervention group (IG). The CG will receive usual care; the IG will receive the SMILe-ICM (see above) over one year with 12 scheduled CC visits and continuous use of the SMILeApp. The re-hospitalization rate (primary outcome) and total healthcare utilization costs (payers' perspective) will be assessed using medical records. Medication adherence will be assessed via the BAASIS© scale, treatment burden via the PETS© scale, health-related quality of life via the EQ-5D-5L© (value set for Germany EQ-VT v. 2.0-quality-adjusted life years), and acute and chronic GvHD episodes and survival via medical records. Implementation outcomes will be assessed from both patient and CC perspectives via questionnaires and the implementation pathway via qualitative data collection techniques (i.e., focus groups with patients, clinicians). Quantitative data will be collected using a blinded standardized method in patients' first year post-alloSCT, then 3 months thereafter. Intention-to-treat and per-protocol analyses will be conducted using the rate ratio by unconditional maximum likelihood estimation (Wald) for the primary outcome. Qualitative data will be analysed using mind-mapping techniques and thematic analysis.

Conclusion: The SMILe-ICM implies a systemic innovation in the follow-up care of alloSCT patients, targeting short- and medium-term outcomes. Bolstering patient's self-management, this eHealth-supported behavioural science-driven integrated care approach aims at fast responses to health deterioration. This implementation science methodological innovation will also develop insights regarding the implementation process. Should it prove effective, then, it will also prepare the SMILe-ICM for scaling up or out to other chronically ill patient populations. ;

Related Conditions & MeSH terms

• Stem Cell Transplantation

• NCT number: NCT04789863
• Study type: Interventional
• Source: University of Basel
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2021
• Completion date: September 30, 2023