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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02933840
Using a Remote Patient Monitoring Alert System to Improve Care
Using a Remote Patient Monitoring Alert System to Improve Care in Geriatric Orthopedic Trauma Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Geriatric orthopedic trauma patients are a particularly vulnerable cohort due to their age and medical complexity. These patients are often admitted to a floor unit with high physician-to-patient and nurse-to-patient ratios, especially during hours of low staffing intensity (eg, nighttime and weekend hours). As a result, during hours of low staffing intensity the potential for acute deterioration with delayed reaction from the care team is significant. The investigators aim to test the efficacy of a remote patient monitoring platform to reduce adverse events in this population during hours of low staffing intensity. The platform is a software called AlertWatch. It takes laboratory and vital sign data that has been reported in the medical record and determines whether it meets a cut-off value that is concerning for patient deterioration. If the value meets that cut-off, it sends a page to a recipient clinician. The investigators will have a physician trained in intensive care receive these alerts and respond to them by evaluating the patient and, in a consultative capacity, assist the primary team, namely the orthopedic surgery service, in taking care of the patient.
Patients will be randomized to intervention and control arms at the outset of their hospitalization. Patients in the intervention arm will receive standard of care monitoring and the primary team responsible for the care of the patient will remain the orthopedic surgery service, however, in addition, the AlertWatch software will be implemented and the intensive care physician will be involved in the patient's care when there is an alert. Patients in the control arm will receive standard of care monitoring and the orthopedic surgery service will be the primary team responsible. The Investigators will measure whether the intervention reduces adverse events in the study population compared with control patients.
All patients will be enrolled consecutively at the time of admission to the hospital. The AlertWatch platform (510(k) FDA clearance K15335) has the ability to automatically detect whether a patient admitted to a bed on the orthopedic surgery service meets inclusion criteria. The platform will automatically randomize patients into the active arm or the control arm of the study. For patients randomized to the active arm, the platform will provide alert monitoring.
The Investigators will also be enrolling intensive care physicians to participate in this study. Physician participation is optional. In advance of the start of the study, they will be provided information regarding the study and an informed consent document.
The AlertWatch platform has the ability to send an alert when it detects abnormalities, particular trends, or combinations of abnormalities or trends. In this study, the Investigators will use specific threshold values to alert for abnormalities and concerning trends in patient data. When an alert is made, it will be sent to the in-house intensive care physician's regular pager. The page will display the data. Orthopedic interns will continue to monitor for patient data in the standard fashion.
The Investigators will institute a protocol in which an intensive care physician is receiving alerts from AlertWatch during nighttime and weekend hours. The intensivist will: 1.) view the alert, 2.) determine whether any subsequent action is warranted. Subsequent actions may include: 1.) reviewing the patient's chart 2.) visiting the patient and/or his/her nurse 3.) paging the orthopedic surgery team to discuss the patient's situation.
There is an extremely low risk that a patient's safety would be at all threatened in either arm of the study. Patients who are assigned to the intervention arm and the control arm will both receive the standard of care. Intervention arm patients will additionally have the AlertWatch software relaying alerts to designated providers. The software does not create new, previously non-existent data. It relays data that is already available and viewable by all providers in the medical record for the patient. Given the nature of the intervention in this study, the likelihood of any adverse events due to the intervention is extremely low.
Tipo de estudio
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Admitted to Massachusetts General Hospital or Brigham and Women's Hospital
- Admitted to orthopedic trauma surgery service
- Admitted to a non-ICU bed (patients initially admitted to an ICU and then transferred to the non-ICU bed will be included)
Exclusion Criteria:
- Admitted to service other than orthopedic trauma surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: AlertWatch
Patients will receive standard monitoring and in addition the AlertWatch software will alert the intensive care physician if there is a value that meets criteria for alerting.
The care team will be the orthopedic surgery team in addition to the intensive care physician being involved as a consultant if he/she receives an alert.
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AlertWatch holds 510(k) FDA clearance K15335.
It is a software program that takes data present in the medical record, including vital signs and laboratory results, and determines whether it meets predetermined thresholds for alerting a clinician.
These thresholds are intended to correlate with signs of acute clinical deterioration in the patient being monitored.
|
|
Sin intervención: No AlertWatch
Patients will receive standard monitoring without the AlertWatch software.
The care team will be the orthopedic surgery team without the intensive care physician being involved as a consultant.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mortality
Periodo de tiempo: One year
|
Whether a patient experiences death during their hospitalization.
|
One year
|
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Transfer to the ICU
Periodo de tiempo: One year
|
Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.
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One year
|
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Cardiac arrest
Periodo de tiempo: One year
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Whether the patient experiences a cardiac arrest during their hospitalization.
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One year
|
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Rapid response team called
Periodo de tiempo: One year
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Whether the a rapid response team is called to assess the patient during their hospitalization.
|
One year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to ordering of blood
Periodo de tiempo: One year
|
Time from hemoglobin < 7 to when blood product is ordered for patient during their hospitalization.
|
One year
|
|
Time to ordering of fluids or vasopressors
Periodo de tiempo: One year
|
Time from systolic blood pressure<80, diastolic<40 to when fluids or vasopressors are ordered for patient during their hospitalization.
|
One year
|
|
Time to ordering of diuretics, NIPPV, or intubation
Periodo de tiempo: One year
|
Time from oxygen saturation<90% to when diuretics, NIPPV, or intubation are ordered for patient during their hospitalization.
|
One year
|
|
Time to ordering of nodal blocking agent
Periodo de tiempo: One year
|
Time from heart rate >130 to when a nodal blocking agent (beta blocker, calcium channel blocker, digoxin, or amiodarone) is ordered for patient during their hospitalization.
|
One year
|
|
Time to ordering of insulin
Periodo de tiempo: One year
|
Time from glucose >350 or <60 to when insulin is ordered for patient during their hospitalization.
|
One year
|
|
Time to ordering of diuretics or insulin/D50
Periodo de tiempo: One year
|
Time from potassium>6 to when diuretics or insulin/D50 is ordered for patient during their hospitalization.
|
One year
|
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Time to ordering of appropriate fluids
Periodo de tiempo: One year
|
Time from sodium>145 or sodium<130 to when appropriate fluids are ordered for patient during their hospitalization.
|
One year
|
|
Time to ordering to discontinue foley catheter
Periodo de tiempo: One year
|
Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.
|
One year
|
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Time to improvement of hemoglobin
Periodo de tiempo: One year
|
Time from hemoglobin <7 to hemoglobin>7
|
One year
|
|
Time to improvement of blood pressure
Periodo de tiempo: One year
|
Time from systolic blood pressure<80, diastolic<40 to systolic blood pressure>80, diastolic>40
|
One year
|
|
Time to improvement of oxygen saturation
Periodo de tiempo: One year
|
Time from oxygen saturation to <90% to oxygen saturation >90%
|
One year
|
|
Time to improvement of heart rate
Periodo de tiempo: One year
|
Time from heart rate >130 to heart rate <130
|
One year
|
|
Time to improvement of glucose
Periodo de tiempo: One year
|
Time from glucose >350 or <60 to glucose <350, >60
|
One year
|
|
Time to improvement of potassium
Periodo de tiempo: One year
|
Time from potassium >6 to potassium to <6
|
One year
|
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Time to improvement of sodium
Periodo de tiempo: One year
|
Time from sodium >145 or <130 to sodium <145, >130
|
One year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Aalok V Agarwala, MD, MBA, Massachusetts General Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2016P002227
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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