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| Name | Class |
|---|---|
| Reimagine Care | UNKNOWN |
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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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post BMT or CAR-T patients receiving care at UCHealth | Experimental | Participants will be recruited for this study from among three discrete patient populations:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioIntelliSense BioButton Rechargable | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients reporting symptoms | Determine the number of patients reporting symptoms via EPRO | 90 Days |
| 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 neurotoxicity events confirmed by clinical evaluation | 90 Days | |
| Number of CRS events confirmed by clinical evaluation | 30 days | |
| Number of tech support contacts received from patients/caregivers |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of patient interactions with RC | Total patient interactions with RC, by type, including EPRO text message conversations, video visits, and phone calls | 90 Days |
| EPRO patient response rates |
| Measure | Description | Time Frame |
|---|---|---|
| Overall patient satisfaction | Number and percent of patients who report overall satisfaction with the intervention based on responses to survey items | 90 days |
| Overall caregiver satisfaction | Number and percent of caregivers who report overall satisfaction with the intervention based on responses to survey items |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glen Peterson | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Memora Health two-way patient engagement platform provided by RC | Other | 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. |
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| 90 Days |
| Minutes RPM devices spent off-body | 90 Days |
The percentage of outbound text messages requesting a response that are responded to by persons activated on the program
| 90 Days |
| Patient retention rate | 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 | 90 Days |
| 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 |
| Number of ICU admissions during study period | 90 Days |
| up to 90 days |
| Overall health care provider satisfaction | Number and percent of providers who report overall satisfaction with the intervention based on responses to survey items | 90 days |
| Perceived quality of life | Number and percent of patients who report overall improvement in perceived quality of life in responses to survey items | 90 days |