Leukemia
Conditions
Keywords
Bone Marrow Transplant (BMT), Chimeric Antigen Receptor T-cell therapy (CAR-T)
Brief summary
To assess the potential for successfully using technology-assisted in-home oncology care to provide improved care coordination and management, and appropriate referral to treatment for patients receiving bone marrow transplant (BMT) or chimeric antigen receptor (CAR) T-cell therapy (CAR-T). The technology-assisted in-home oncology care program includes remote patient monitoring (RPM), telemedicine, and home-based health care services.
Detailed description
The objective of this study is to assess the potential for successfully using technology-assisted in-home oncology care to provide improved care coordination and management, and appropriate referral to treatment for patients receiving bone marrow transplant (BMT) or chimeric antigen receptor (CAR) T-cell therapy (CAR-T). The technology-assisted in-home oncology care program includes remote patient monitoring (RPM), telemedicine, and home-based health care services. The study focuses on evaluating the technical feasibility, operational feasibility, and perceived patient, caregiver and healthcare provider experience of a combined package of technology-assisted in-home oncology care services to monitor for febrile neutropenia, infection, cyotokine release syndrome, neurotoxicity or other symptomatic episodes needing management up to 90 days post allogeneic BMT, up to 30 days post autologous BMT, and up to 30 days post CAR-T. It includes the following specific aims and hypotheses:
Interventions
OTHERBioIntelliSense BioButton Rechargable
This study uses the BioIntelliSense BioButton Rechargeable for RPM, in combination with the BioSync mobile app on participants' mobile phones for data transmission, augmented by use of the BioHub as a backup transmission device. RPM monitoring of device data is accomplished through use of the AlertWatch software system.
OTHERMemora Health two-way patient engagement platform provided by RC
The Memora Health platform is designed to automate complex care workflows, making them simple for patients and clinicians to navigate. It utilizes a multi-modal communications system that primarily relies on two-way text messaging and artificial intelligence.
Sponsors
Reimagine Care
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 years to 89 years old * Bone marrow transplant recipients (allogeneic and autologous) or CAR-T patients * Determined by care provider to be stable for discharge to home setting for outpatient care according to clinical practice standard operating procedures (SOPs) * Residing in the Denver metro area for the duration of the study within 45 minutes of the AMC * Has in-home caregiver support 24/7 (i.e., does not live alone) * Has self-reported reliable telephone and home internet service and a stable wireless network * Patient agrees to not submerge the BioButton Rechargeable device in more than 3 feet of water or submerge for longer than 30 minutes at a time. * Patient owns or possesses, as the primary user with reliable daily access, a mobile device (iOS or Android) capable of running the study's mobile applications and accepting the terms and conditions * Patient has SMS texting capacity and an unlimited texting plan or other plan sufficient for study text messaging without undue patient burden * Patient is willing to complete and log a self-check of temperature twice daily and return the log to the study team at the end of the study * Patient is willing to be available for the duration of the study * Patient has access to reliable transportation to the hospital 24/7
Exclusion criteria
* Patients will be excluded from study participation if the PI or designated care provider believes study participation would not be in the patient's best interest for clinical reasons. * Patients may also be excluded from study participation if in the opinion of the PI they have a medical condition that may impede their ability to adhere to the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of neurotoxicity events confirmed by clinical evaluation | 90 Days | — |
| Number of patients reporting symptoms | 90 Days | Determine the number of patients reporting symptoms via EPRO |
| Number of alerts generated through RPM systems | 30 days | — |
| Number of potential febrile events detected via RPM | 90 Days | — |
| Number of potential infections detected via RPM | 90 Days | — |
| Number of potential neurotoxicity events detected via RPM | 90 Days | — |
| Number of potential cytokine release syndrome (CRS) events detected via RPM | 90 Days | — |
| Number of febrile neutropenia events confirmed by clinical evaluation | 90 Days | — |
| Number of infections confirmed by clinical evaluation | 90 Days | — |
| Number of CRS events confirmed by clinical evaluation | 30 days | — |
| Minutes RPM devices spent off-body | 90 Days | — |
| Number of tech support contacts received from patients/caregivers | 90 Days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ICU admissions during study period | 90 Days | — |
| Total number of patient interactions with RC | 90 Days | Total patient interactions with RC, by type, including EPRO text message conversations, video visits, and phone calls |
| EPRO patient response rates | 90 Days | The percentage of outbound text messages requesting a response that are responded to by persons activated on the program |
| Patient retention rate | 90 Days | The percentage of patients that remain actively engaged with the program by exchanging at least one text message or having at least one telehealth encounter with the VCC per week |
| Number of calls escalated to CU/UCHealth for clinical evaluation and follow-up with study participants | 90 Days | — |
| Number of hospital admissions during study period | 90 Days | — |
| Length of stay for hospital admissions during study period | up to 90 days | — |
| Total days in hospital during study period | 90 Days | — |
| Number of emergency room visits during study period | 90 Days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall patient satisfaction | 90 days | Number and percent of patients who report overall satisfaction with the intervention based on responses to survey items |
| Perceived quality of life | 90 days | Number and percent of patients who report overall improvement in perceived quality of life in responses to survey items |
| Overall health care provider satisfaction | 90 days | Number and percent of providers who report overall satisfaction with the intervention based on responses to survey items |
| Overall caregiver satisfaction | up to 90 days | Number and percent of caregivers who report overall satisfaction with the intervention based on responses to survey items |
Countries
United States
Outcome results
None listed