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Using a Remote Patient Monitoring Alert System to Improve Care

29 ottobre 2019 aggiornato da: Aalok Agarwala, Massachusetts General Hospital

Using a Remote Patient Monitoring Alert System to Improve Care in Geriatric Orthopedic Trauma Patients

The purpose of this study is to determine the efficacy of a remote patient monitoring platform and alert system in reducing adverse events for hospitalized geriatric orthopedic trauma patients.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mortality
Lasso di tempo: One year
Whether a patient experiences death during their hospitalization.
One year
Transfer to the ICU
Lasso di tempo: One year
Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.
One year
Cardiac arrest
Lasso di tempo: One year
Whether the patient experiences a cardiac arrest during their hospitalization.
One year
Rapid response team called
Lasso di tempo: One year
Whether the a rapid response team is called to assess the patient during their hospitalization.
One year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to ordering of blood
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: One year
Time from potassium>6 to when diuretics or insulin/D50 is ordered for patient during their hospitalization.
One year
Time to ordering of appropriate fluids
Lasso di tempo: 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
Lasso di tempo: One year
Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.
One year
Time to improvement of hemoglobin
Lasso di tempo: One year
Time from hemoglobin <7 to hemoglobin>7
One year
Time to improvement of blood pressure
Lasso di tempo: 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
Lasso di tempo: One year
Time from oxygen saturation to <90% to oxygen saturation >90%
One year
Time to improvement of heart rate
Lasso di tempo: One year
Time from heart rate >130 to heart rate <130
One year
Time to improvement of glucose
Lasso di tempo: One year
Time from glucose >350 or <60 to glucose <350, >60
One year
Time to improvement of potassium
Lasso di tempo: One year
Time from potassium >6 to potassium to <6
One year
Time to improvement of sodium
Lasso di tempo: One year
Time from sodium >145 or <130 to sodium <145, >130
One year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Aalok V Agarwala, MD, MBA, Massachusetts General Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2017

Completamento primario (Effettivo)

1 gennaio 2017

Completamento dello studio (Effettivo)

1 gennaio 2017

Date di iscrizione allo studio

Primo inviato

12 ottobre 2016

Primo inviato che soddisfa i criteri di controllo qualità

13 ottobre 2016

Primo Inserito (Stima)

14 ottobre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

31 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 ottobre 2019

Ultimo verificato

1 ottobre 2019

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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