Clinical Trial: Using a Remote Patient Monitoring Alert System to Improve Care

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.<
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

  • Mortality [ Time Frame: One year ]
    Whether a patient experiences death during their hospitalization.
  • Transfer to the ICU [ Time Frame: One year ]
    Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.
  • Cardiac arrest [ Time Frame: One year ]
    Whether the patient experiences a cardiac arrest during their hospitalization.
  • Rapid response team called [ Time Frame: One year ]
    Whether the a rapid response team is called to assess the patient during their hospitalization.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to ordering of blood [ Time Frame: One year ]
    Time from hemoglobin < 7 to when blood product is ordered for patient during their hospitalization.
  • Time to ordering of fluids or vasopressors [ Time Frame: One year ]
    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 Frame: One year ]
    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 Frame: 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.
  • Time to ordering of insulin [ Time Frame: One year ]
    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 Frame: One year ]
    Time from potassium>6 to when diuretics or insulin/D50 is ordered for patient during their hospitalization.
  • Time to ordering of appropriate fluids [ Time Frame: One year ]
    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 Frame: One year ]
    Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.
  • Time to improvement of hemoglobin [ Time Frame: One year ]
    Time from hemoglobin <7 to hemoglobin>7
  • Time to improvement of blood pressure [ Time Frame: One year ]
    Time from systolic blood pressure<80, diastolic<40 to systolic blood pressure>80, diastolic>40
  • Time to improvement of oxygen saturation [ Time Frame: One year ]
    Time from oxygen saturation to <90% to oxygen saturation >90%
  • Time to improvement of heart rate [ Time Frame: One year ]
    Time from heart rate >130 to heart rate <130
  • Time to improvement of glucose [ Time Frame: One year ]
    Time from glucose >350 or <60 to glucose <350, >60
  • Time to improvement of potassium [ Time Frame: One year ]
    Time from potassium >6 to potassium to <6
  • Time to improvement of sodium [ Time Frame: One year ]
    Time from sodium >145 or <130 to sodium <145, >130


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: October 12, 2016
Date Started: January 2017
Date Completion: March 2018
Last Updated: October 13, 2016
Last Verified: October 2016