Clinical trial NCT04789863: Implementation and Testing of an eHealth Integrated Model of Care for Patients Receiving Allogeneic Stem Cell Transplantation: The SMILe Project
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stem Cell Transplantation
Keywords: Implementation Science
Delivery of Health Care, Integrated
Telemedicine
Advanced Practice Nursing
Randomized Controlled Trial
Self-Management
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: University Hospital Freiburg
name: University Hospital, Basel, Switzerland
name: University of Applied Science Augsburg, Germany
name: KU Leuven
name: University Hospital, Zürich
name: University Hospital, Geneva
First posted: 2021-03-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patient's allogeneic stem cell transplantation and follow-up treatment is planned at the University Hospital Basel
* Aged ≥ 18 years
* Able to speak, read and write German at least limited working proficiency (i.e., to satisfy conversations and understand written material regarding routine social demands and limited requirements)
* Able to plan and perform self- management activities independently
* WLAN access at home or own a sufficient mobile data contract
* Normal, mental, physical and psychological abilities and health to provide a written informed consent about study participation and related data protection

Exclusion Criteria:

* General condition make self-management impossible for more than 4 weeks
* Follow up care solely at an external center
* Diagnosed with dementia
* A second allogeneic stem cell transplantation becomes necessary

Primary outcomes:
measure: Change of re-hospitalization rate from post-alloSCT discharge up to 15 months after allogeneic stem cell transplantation
timeFrame: Data will be collected monthly via medical records during the study period, i.e., until one year post-alloSCT and for a further period of 3 months to test for a possible wane out effect.
Secondary outcomes:
measure: Change of total healthcare utilization costs from post-alloSCT discharge until 15 months post-alloSCT
timeFrame: Data will be collected monthly during the study period, i.e., until one year post-alloSCT and for a further period of 3 months to test for a possible wane out effect.
measure: Change of medication adherence from post-alloSCT discharge until 15 months post-alloSCT
timeFrame: Data will be collected monthly (BAASIS©) and daily (MEMS® Button) during the study period as long as patients need to take immunosuppressants, i.e., at the longest until 1 year post-alloSCT and for a further period of 3 months.
measure: Change of treatment burden from baseline until 12 months post-alloSCT
timeFrame: Data will be collected at baseline, days +90, +180 and +365 via self-report questionnaire (PETS©) during the intervention period.
measure: Change of HRQL from baseline until 12 months post-alloSCT
timeFrame: Data will be collected monthly via medical records during the intervention period, i.e., until one year post-alloSCT.
measure: Change of QALY from baseline until 12 months post-alloSCT
timeFrame: Data will be collected monthly during the intervention period, i.e., until one year post-alloSCT.
measure: Change of GvHD from post-alloSCT until 12 months post-alloSCT
timeFrame: Data will be collected monthly during the intervention period, i.e., until one year post-alloSCT.
measure: Change of implementation outcomes and process evaluation from baseline until 15 months post-alloSCT
timeFrame: Data will be collected monthly via medical records during the study period, i.e., until one year post-alloSCT and for a further period of 3 months to test for a possible wane out effect.
measure: Change of overall survival rate from post-alloSCT until 15 months post-alloSCT
timeFrame: Data will be collected via medical records at days +30, +60, +90, +120, +150, +180, +240, +300, +365 and +455
measure: Patient's demographics at baseline
timeFrame: At baseline: 10 days before alloSCT
measure: Patient's clinical characteristics at baseline
timeFrame: At baseline: 10 days before alloSCT
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Nursing Science, Department Public Health, University of Basel, Switzerland
name: Sabine De Geest, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Geest S, Valenta S, Ribaut J, Gerull S, Mielke J, Simon M, Bartakova J, Kaier K, Eckstein J, Leppla L, Teynor A; SMILe team. The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial. BMC Health Serv Res. 2022 Aug 20;22(1):1067. doi: 10.1186/s12913-022-08293-8.