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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04789863
• Other study ID #: SMILe
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2022
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stem Cell Transplantation

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (7)

Lead Sponsor	Collaborator
University of Basel	KU Leuven, University Hospital Freiburg, University Hospital, Basel, Switzerland, University Hospital, Geneva, University Hospital, Zürich, University of Applied Science Augsburg, Germany

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of re-hospitalization rate from post-alloSCT discharge up to 15 months after allogeneic stem cell transplantation	The number of events after the initial post-alloSCT discharge per patient	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	Change of total healthcare utilization costs from post-alloSCT discharge until 15 months post-alloSCT	Will be calculated from the payers' perspective, i.e., based on type of insurance (public/private), standardized unit costs of resources in Switzerland, and medical records. Costs for 5 healthcare utilization classes will be counted: physician visits, ambulatory healthcare visits, rehabilitation services, home care services, inpatient days. Information about home care services is not available via medical records and will be obtained via an adapted version of the FIMA© self-reporting questionnaire. For this study, the FIMA© was shortened to 7 items, asking retrospectively for number of physicians visits, d/hrs of ambulatory healthcare visits, d/hrs of home care services, d/hrs of support by family caregivers, type & duration of rehabilitation therapy, reason & duration of inpatient days, type of insurance. Comparing the data collected via the FIMA© will check the data validity of medical records. In case of incongruences, valid data from medical records will be used.	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.
Secondary	Change of medication adherence from post-alloSCT discharge until 15 months post-alloSCT	Medication non-adherence (implementation & persistence dimension) will be assessed using the Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©).The BAASIS© is a validated self-report measure assessing adherence to implementation issues (e.g., drug holidays; 4 items; YES/NO) and persistence/discontinuation (1 item; Yes/No). In addition, we will apply electronic monitoring (EM), i.e., the MEMS® Button, an electronic pillbox system recording the date and time of each medication intake. As described in our previous MAESTRO-TX study, the electronically compiled dosing history will be expressed as a sequence of daily binary adherence scores per patient.	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.
Secondary	Change of treatment burden from baseline until 12 months post-alloSCT	Treatment burden will be measured via the German version of the PETS© self-reporting questionnaire. This includes nine multi-item domain scales, each measuring the burden of one aspect of chronic illness treatment: medical information (7 items); medications (7 items); medical appointments (3 items); health monitoring (2 items); interpersonal challenges (4 items); health care expenses (5 items); difficulty with health care services (7 items); role/social activity limitations due to self-management (6 items); and physical/mental exhaustion due to self-management (5 items). Items apply 4- or 5-point Likert-type response scales regarding a 4-week recall time frame. Raw domain scores are transformed to a standardized 0-to-100 metric, with higher scores indicating greater treatment burden.	Data will be collected at baseline, days +90, +180 and +365 via self-report questionnaire (PETS©) during the intervention period.
Secondary	Change of HRQL from baseline until 12 months post-alloSCT	HRQL will be measured using the EQ-5D-5L©,a validated instrument covering five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and including the EQ-Visual Analogue Scale (VAS), on which individuals rate their overall perceived health state (scale of 0 to 100).	Data will be collected monthly via medical records during the intervention period, i.e., until one year post-alloSCT.
Secondary	Change of QALY from baseline until 12 months post-alloSCT	We will also calculate quality-adjusted life years (QALY), as QALY scores are required for the National Institute for Health and Clinical Excellence (NICE) health technology assessment. As a standardized measure of disease burden which combines both survival and health-related quality of life into a single index, the QALY scores provide a 'common currency' of comparison across disease areas. Generating them requires the preference weight of HRQL (obtained from the EQ-5D-5L© value set for Germany EQ-VT v. 2.0) and time between each HRQL measurement. QALY scores range from 1 (perfect health) to 0 (dead).	Data will be collected monthly during the intervention period, i.e., until one year post-alloSCT.
Secondary	Change of GvHD from post-alloSCT until 12 months post-alloSCT	Incidence and grade of chronic and acute GvHD will be retrieved from medical records.	Data will be collected monthly during the intervention period, i.e., until one year post-alloSCT.
Secondary	Change of implementation outcomes and process evaluation from baseline until 15 months post-alloSCT	Overall survival rate will be retrieved from medical records.	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	Change of overall survival rate from post-alloSCT until 15 months post-alloSCT	Overall survival rate after having received the alloSCT	Data will be collected via medical records at days +30, +60, +90, +120, +150, +180, +240, +300, +365 and +455
Secondary	Patient's demographics at baseline	Patient's demographics will be assessed as follows: age, sex, education, living alone	At baseline: 10 days before alloSCT
Secondary	Patient's clinical characteristics at baseline	Patient's clinical characteristics will be assessed as follows: conditioning regimen, donor match/type, disease status at transplant, time diagnosis to transplant	At baseline: 10 days before alloSCT