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.
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
- Conditions the study is for
- Fractures, Bone, Cardiovascular Abnormalities, Respiratory System Abnormalities
- 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.
- Conditions
- Fractures, Bone, Cardiovascular Abnormalities, Respiratory System Abnormalities, Hemorrhage
- 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 group | Role | What they receive |
|---|---|---|
| AlertWatch | Experimental | 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. Receives: Device: AlertWatch |
| No AlertWatch | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Whether a patient experiences death during their hospitalization.
Measured: One year
Transfer to the ICU
Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.
Measured: One year
Cardiac arrest
Whether the patient experiences a cardiac arrest during their hospitalization.
Measured: One year
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)
Time to ordering of blood
Time from hemoglobin < 7 to when blood product is ordered for patient during their hospitalization.
Measured: One year
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
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
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
Time to ordering of insulin
Time from glucose >350 or <60 to when insulin is ordered for patient during their hospitalization.
Measured: One year
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
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
Time to ordering to discontinue foley catheter
Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.
Measured: One year
Time to improvement of hemoglobin
Time from hemoglobin <7 to hemoglobin>7
Measured: One year
Time to improvement of blood pressure
Time from systolic blood pressure<80, diastolic<40 to systolic blood pressure>80, diastolic>40
Measured: One year
Time to improvement of oxygen saturation
Time from oxygen saturation to <90% to oxygen saturation >90%
Measured: One year
Time to improvement of heart rate
Time from heart rate >130 to heart rate <130
Measured: One year
Time to improvement of glucose
Time from glucose >350 or <60 to glucose <350, >60
Measured: One year
Time to improvement of potassium
Time from potassium >6 to potassium to <6
Measured: One year
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.
- First posted14 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Target patient population reevaluated prior to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Aalok Agarwala, Massachusetts General Hospital
- Investigators
- Aalok V Agarwala, MD, MBA, Principal investigator, Massachusetts General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Remote Patient Monitoring Alert System to Improve Care in Geriatric Orthopedic Trauma Patients
- ClinicalTrials.gov ID
- NCT02933840
- Acronym / sponsor ID
- 2016P002227
- Conditions
- Fractures, Bone, Cardiovascular Abnormalities, Respiratory System Abnormalities, Hemorrhage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Target patient population reevaluated prior to enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jan 2017
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AlertWatch | Experimental | Device: AlertWatchPatients 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. |
| No AlertWatch | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Admitted to service other than orthopedic trauma surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlertWatchAlertWatch 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. | Device | AlertWatch |
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.
15 secondary outcomes
Time to ordering of blood
Time frame: One year
Time to ordering of fluids or vasopressors
Time frame: One year
Time to ordering of diuretics, NIPPV, or intubation
Time frame: One year
Time to ordering of nodal blocking agent
Time frame: One year
Time to ordering of insulin
Time frame: One year
Time to ordering of diuretics or insulin/D50
Time frame: One year
Time to ordering of appropriate fluids
Time frame: One year
Time to ordering to discontinue foley catheter
Time frame: One year
Time to improvement of hemoglobin
Time frame: One year
Time to improvement of blood pressure
Time frame: One year
Time to improvement of oxygen saturation
Time frame: One year
Time to improvement of heart rate
Time frame: One year
Time to improvement of glucose
Time frame: One year
Time to improvement of potassium
Time frame: One year
Time to improvement of sodium
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Fractures, Bone
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aalok V Agarwala, MD, MBA principal investigator
Massachusetts General Hospital
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.