The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial

Sabina De Geest, Sabine Valenta, Janette Ribaut, Sabine Gerull, Juliane Mielke, Michael Simon, Jana Bartakova, Klaus Kaier, Jens Eckstein, Lynn Leppla, Alexandra Teynor, SMILe team, Sabina De Geest, Sabine Valenta, Janette Ribaut, Sabine Gerull, Juliane Mielke, Michael Simon, Jana Bartakova, Klaus Kaier, Jens Eckstein, Lynn Leppla, Alexandra Teynor, SMILe team

Abstract

Background: While effectiveness outcomes of eHealth-facilitated integrated care models (eICMs) in transplant and oncological populations are promising, implementing and sustaining them in real-world settings remain challenging. Allogeneic stem cell transplant (alloSCT) patients could benefit from an eICM to enhance health outcomes. To combat health deterioration, integrating chronic illness management, including continuous symptom and health behaviour monitoring, can shorten reaction times. We will test the 1st-year post-alloSCT effectiveness and evaluate bundled implementation strategies to support the implementation of a newly developed and adapted eICM in allogeneic stem cell transplantation facilitated by eHealth (SMILe-ICM). SMILe-ICM has been designed by combining implementation, behavioural, and computer science methods. Adaptions were guided by FRAME and FRAME-IS. It consists of four modules: 1) monitoring & follow-up; 2) infection prevention; 3) physical activity; and 4) medication adherence, delivered via eHealth and a care coordinator (an Advanced Practice Nurse). The implementation was supported by contextually adapted implementation strategies (e.g., creating new clinical teams, informing local opinion leaders).

Methods: Using a hybrid effectiveness-implementation randomised controlled trial, we will include a consecutive sample of 80 adult alloSCT patients who were transplanted and followed by University Hospital Basel (Switzerland). Inclusion criteria are basic German proficiency; elementary computer literacy; internet access; and written informed consent. Patients will be excluded if their condition prevents the use of technology, or if they are followed up only at external centres. Patient-level (1:1) stratified randomisation into a usual care group and a SMILe-ICM group will take place 10 days pre-transplantation. To gauge the SMILe-ICM's effectiveness primary outcome (re-hospitalisation 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 will use multi-method, multi-informant assessment (via questionnaires, interviews, electronic health record data, cost capture methods).

Discussion: The SMILe-ICM has major innovative potential for reengineering alloSCT follow-up care, particularly regarding short- and medium-term outcomes. Our dual focus on implementation and effectiveness will both inform optimization of the SMILe-ICM and provide insights regarding implementation strategies and pathway, understudied in eHealth-facilitated ICMs in chronically ill populations.

Trial registration: ClinicalTrials.gov. Identifier: NCT04789863 . Registered April 01, 2021.

Keywords: Advanced practice nurses; Care coordination; Hybrid effectiveness-implementation study; Implementation outcomes; Implementation strategies; Randomised controlled trial; Re-hospitalisations; Stem cell transplantation; eHealth.

Conflict of interest statement

This study was approved by the responsible ethics committee, Ethics Committee Northwest and Central Switzerland (EKNZ: 2021–00202) and monitored by the Clinical Trial Unit (CTU), University Hospital Basel, Switzerland (https://dkf.unibas.ch/en/services/monitoring/), who are. Independent from the sponsor and competing interests: An initial site visit and in total three monitoring visits will be conducted within the trial phase by the responsible monitor of the CTU. Any adverse events and other unintended effects of trial interventions will be directly reported to ethic committee and CTU.

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Overview of the SMILe Project’s two phases. Abbreviations. ICM = Integrated care Model; RCT = randomised controlled trial
Fig. 2
Fig. 2
The SMILe–Integrated Care Model. Abbreviations. alloSCTs = allogeneic stem cell transplantation; APN = Advanced Practice Nurse;; CC: Care Coordinator; eCCM = eHealth enhanced Chronic Care Model
Fig. 3
Fig. 3
The Hybrid effectiveness-implementation RCT study design. Note. QUAL = qualitative methods; QUAN = quantitative methods; RCT = randomised controlled trial; *Timepoints data collection T0b–Tz (±7 days)
Fig. 4
Fig. 4
Consort flowchart
Fig. 5
Fig. 5
The SMILe LOGIC model

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Source: PubMed

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