Using a Remote Patient Monitoring Alert System to Improve Care
Primary Purpose
Fractures, Bone, Cardiovascular Abnormalities, Respiratory System Abnormalities
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AlertWatch
Sponsored by
About this trial
This is an interventional prevention trial for Fractures, Bone
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AlertWatch
No AlertWatch
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mortality
Whether a patient experiences death during their hospitalization.
Transfer to the ICU
Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.
Cardiac arrest
Whether the patient experiences a cardiac arrest during their hospitalization.
Rapid response team called
Whether the a rapid response team is called to assess the patient during their hospitalization.
Secondary Outcome Measures
Time to ordering of blood
Time from hemoglobin < 7 to when blood product is ordered for patient during their hospitalization.
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.
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.
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.
Time to ordering of insulin
Time from glucose >350 or <60 to when insulin is ordered for patient during their hospitalization.
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.
Time to ordering of appropriate fluids
Time from sodium>145 or sodium<130 to when appropriate fluids are ordered for patient during their hospitalization.
Time to ordering to discontinue foley catheter
Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.
Time to improvement of hemoglobin
Time from hemoglobin <7 to hemoglobin>7
Time to improvement of blood pressure
Time from systolic blood pressure<80, diastolic<40 to systolic blood pressure>80, diastolic>40
Time to improvement of oxygen saturation
Time from oxygen saturation to <90% to oxygen saturation >90%
Time to improvement of heart rate
Time from heart rate >130 to heart rate <130
Time to improvement of glucose
Time from glucose >350 or <60 to glucose <350, >60
Time to improvement of potassium
Time from potassium >6 to potassium to <6
Time to improvement of sodium
Time from sodium >145 or <130 to sodium <145, >130
Full Information
NCT ID
NCT02933840
First Posted
October 12, 2016
Last Updated
October 29, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02933840
Brief Title
Using a Remote Patient Monitoring Alert System to Improve Care
Official Title
Using a Remote Patient Monitoring Alert System to Improve Care in Geriatric Orthopedic Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Target patient population reevaluated prior to enrollment
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone, Cardiovascular Abnormalities, Respiratory System Abnormalities, Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AlertWatch
Arm Type
Experimental
Arm Description
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.
Arm Title
No AlertWatch
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AlertWatch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality
Description
Whether a patient experiences death during their hospitalization.
Time Frame
One year
Title
Transfer to the ICU
Description
Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.
Time Frame
One year
Title
Cardiac arrest
Description
Whether the patient experiences a cardiac arrest during their hospitalization.
Time Frame
One year
Title
Rapid response team called
Description
Whether the a rapid response team is called to assess the patient during their hospitalization.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Time to ordering of blood
Description
Time from hemoglobin < 7 to when blood product is ordered for patient during their hospitalization.
Time Frame
One year
Title
Time to ordering of fluids or vasopressors
Description
Time from systolic blood pressure<80, diastolic<40 to when fluids or vasopressors are ordered for patient during their hospitalization.
Time Frame
One year
Title
Time to ordering of diuretics, NIPPV, or intubation
Description
Time from oxygen saturation<90% to when diuretics, NIPPV, or intubation are ordered for patient during their hospitalization.
Time Frame
One year
Title
Time to ordering of nodal blocking agent
Description
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.
Time Frame
One year
Title
Time to ordering of insulin
Description
Time from glucose >350 or <60 to when insulin is ordered for patient during their hospitalization.
Time Frame
One year
Title
Time to ordering of diuretics or insulin/D50
Description
Time from potassium>6 to when diuretics or insulin/D50 is ordered for patient during their hospitalization.
Time Frame
One year
Title
Time to ordering of appropriate fluids
Description
Time from sodium>145 or sodium<130 to when appropriate fluids are ordered for patient during their hospitalization.
Time Frame
One year
Title
Time to ordering to discontinue foley catheter
Description
Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.
Time Frame
One year
Title
Time to improvement of hemoglobin
Description
Time from hemoglobin <7 to hemoglobin>7
Time Frame
One year
Title
Time to improvement of blood pressure
Description
Time from systolic blood pressure<80, diastolic<40 to systolic blood pressure>80, diastolic>40
Time Frame
One year
Title
Time to improvement of oxygen saturation
Description
Time from oxygen saturation to <90% to oxygen saturation >90%
Time Frame
One year
Title
Time to improvement of heart rate
Description
Time from heart rate >130 to heart rate <130
Time Frame
One year
Title
Time to improvement of glucose
Description
Time from glucose >350 or <60 to glucose <350, >60
Time Frame
One year
Title
Time to improvement of potassium
Description
Time from potassium >6 to potassium to <6
Time Frame
One year
Title
Time to improvement of sodium
Description
Time from sodium >145 or <130 to sodium <145, >130
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aalok V Agarwala, MD, MBA
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Using a Remote Patient Monitoring Alert System to Improve Care
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