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Fractures, BoneNCT02933840

Using a Remote Patient Monitoring Alert System to Improve Care

A study testing AlertWatch in people with Fractures, Bone and Cardiovascular Abnormalities, run by Massachusetts General Hospital.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
AlertWatch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2017to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • Admitted to service other than orthopedic trauma surgery

About this study

Official title: 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.

Read the 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.

Being tested
AlertWatch
Medical subject headings
Fractures, Bone, Cardiovascular Abnormalities, Respiratory System Abnormalities, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlertWatchDevice

    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.

Study groups in NCT02933840
Study groupRoleWhat they receive
AlertWatchExperimentalPatients 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.
Receives: Device: AlertWatch
No AlertWatchNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Whether a patient experiences death during their hospitalization.

    Measured: One year

  2. Transfer to the ICU

    Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.

    Measured: One year

  3. Cardiac arrest

    Whether the patient experiences a cardiac arrest during their hospitalization.

    Measured: One year

  4. Rapid response team called

    Whether the a rapid response team is called to assess the patient during their hospitalization.

    Measured: One year

Secondary outcomes (15)
  1. Time to ordering of blood

    Time from hemoglobin < 7 to when blood product is ordered for patient during their hospitalization.

    Measured: One year

  2. 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.

    Measured: One year

  3. 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.

    Measured: One year

  4. 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.

    Measured: One year

  5. Time to ordering of insulin

    Time from glucose >350 or <60 to when insulin is ordered for patient during their hospitalization.

    Measured: One year

  6. 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.

    Measured: One year

  7. Time to ordering of appropriate fluids

    Time from sodium>145 or sodium<130 to when appropriate fluids are ordered for patient during their hospitalization.

    Measured: One year

  8. Time to ordering to discontinue foley catheter

    Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.

    Measured: One year

  9. Time to improvement of hemoglobin

    Time from hemoglobin <7 to hemoglobin>7

    Measured: One year

  10. Time to improvement of blood pressure

    Time from systolic blood pressure<80, diastolic<40 to systolic blood pressure>80, diastolic>40

    Measured: One year

  11. Time to improvement of oxygen saturation

    Time from oxygen saturation to <90% to oxygen saturation >90%

    Measured: One year

  12. Time to improvement of heart rate

    Time from heart rate >130 to heart rate <130

    Measured: One year

  13. Time to improvement of glucose

    Time from glucose >350 or <60 to glucose <350, >60

    Measured: One year

  14. Time to improvement of potassium

    Time from potassium >6 to potassium to <6

    Measured: One year

  15. Time to improvement of sodium

    Time from sodium >145 or <130 to sodium <145, >130

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2017
  4. Study completionJan 2017

Why it stopped: Target patient population reevaluated prior to enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02933840
Sponsor's protocol ID
2016P002227
Status last verified
Oct 2019
First submitted
12 Oct 2016
Last updated
31 Oct 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AlertWatch in people with Fractures, Bone and Cardiovascular Abnormalities, run by Massachusetts General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.

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