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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Withdrawn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
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fractures, Bone

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 12, 2016
    Last Updated
    October 29, 2019
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Brigham and Women's Hospital
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    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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