Using a Remote Patient Monitoring Alert System to Improve Care

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02933840
• Other study ID #: 2016P002227
• Status: Withdrawn
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2017

Study information

• Verified date: October 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Congenital Abnormalities
• Fractures, Bone
• Hemorrhage
• Respiratory System Abnormalities

Intervention

Device:
• AlertWatch
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Whether a patient experiences death during their hospitalization.	One year
Primary	Transfer to the ICU	Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.	One year
Primary	Cardiac arrest	Whether the patient experiences a cardiac arrest during their hospitalization.	One year
Primary	Rapid response team called	Whether the a rapid response team is called to assess the patient during their hospitalization.	One year
Secondary	Time to ordering of blood	Time from hemoglobin < 7 to when blood product is ordered for patient during their hospitalization.	One year
Secondary	Time to ordering of fluids or vasopressors	Time from systolic blood pressure<80, diastolic<40 to when fluids or vasopressors are ordered for patient during their hospitalization.	One year
Secondary	Time to ordering of diuretics, NIPPV, or intubation	Time from oxygen saturation<90% to when diuretics, NIPPV, or intubation are ordered for patient during their hospitalization.	One year
Secondary	Time to ordering of nodal blocking agent	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
Secondary	Time to ordering of insulin	Time from glucose >350 or <60 to when insulin is ordered for patient during their hospitalization.	One year
Secondary	Time to ordering of diuretics or insulin/D50	Time from potassium>6 to when diuretics or insulin/D50 is ordered for patient during their hospitalization.	One year
Secondary	Time to ordering of appropriate fluids	Time from sodium>145 or sodium<130 to when appropriate fluids are ordered for patient during their hospitalization.	One year
Secondary	Time to ordering to discontinue foley catheter	Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.	One year
Secondary	Time to improvement of hemoglobin	Time from hemoglobin <7 to hemoglobin>7	One year
Secondary	Time to improvement of blood pressure	Time from systolic blood pressure<80, diastolic<40 to systolic blood pressure>80, diastolic>40	One year
Secondary	Time to improvement of oxygen saturation	Time from oxygen saturation to <90% to oxygen saturation >90%	One year
Secondary	Time to improvement of heart rate	Time from heart rate >130 to heart rate <130	One year
Secondary	Time to improvement of glucose	Time from glucose >350 or <60 to glucose <350, >60	One year
Secondary	Time to improvement of potassium	Time from potassium >6 to potassium to <6	One year
Secondary	Time to improvement of sodium	Time from sodium >145 or <130 to sodium <145, >130	One year