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

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.

Conditions

• Stem Cell Transplantation

Interventions

DEVICE

SMILe-Integrated Care Model

Four self-management intervention modules will be delivered by human and technology: 1) monitoring \& follow-up; 2) infection prevention; 3) medication adherence; 4) physical activity. Human. A CC will provide structured and tailored self-management and behavioural support regarding all 4 modules via 12 face-to-face meetings congruent with planned clinic follow-up visits. The CC will be connected with the patients via the SMILe technology, enabling rapid responses to early signs of health deterioration. Technology. The SMILe technology consists of the SMILeApp and SMILeCare. The latter is the interface of the monitoring component to connect the patient with the CC supporting fast recognition of symptoms and health deterioration. The SMILeApp enables to daily record a set of medical, behavioural and symptom-related data. A lexicon provides self-management and behavioural information. All data will be transferred to the clinic to be monitored, with the patient's consent, via SMILeCare.

OTHER

Usual Care

The control group (CG) participants will receive usual care, which includes no specific counselling. USB outpatient appointment frequency follows a standard schedule: during the first 3 months post-alloSCT, depending on their health status, most patients (73%) return 1 to 3 times per week for follow-up at the USB outpatient clinic, where they are mainly seen by a junior or senior physician. Depending on health status and recovery, follow-up intervals extend to weekly or monthly within 1 year post-alloSCT. A research assistant (RA) will just contact CG participants for data collection. If participants raise concerns about any symptoms, the RA will encourage them to contact their physicians.

Sponsors & Collaborators

• University Hospital Freiburg

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• University of Applied Science Augsburg, Germany

  collaborator UNKNOWN

• KU Leuven

  collaborator OTHER

• University Hospital, Zürich

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• University of Basel

  lead OTHER

Principal Investigators

• Sabine De Geest, Prof. · Nursing Science, Department Public Health, University of Basel, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2023-10-31

Completion

2023-10-31

Countries

• Switzerland

Study Locations