Hemorrhage Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02815670 -
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
|
Phase 3 | |
Completed |
NCT04588350 -
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
|
N/A | |
Recruiting |
NCT02972385 -
Pharmacogenomics of Warfarin in Hispanics and Latinos
|
||
Completed |
NCT02569606 -
Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
|
||
Completed |
NCT02554006 -
Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings
|
N/A | |
Recruiting |
NCT02446730 -
Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome
|
Phase 4 | |
Completed |
NCT01935427 -
Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume
|
N/A | |
Completed |
NCT01955720 -
Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
|
Phase 1 | |
Recruiting |
NCT01709786 -
Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage
|
N/A | |
Completed |
NCT01191554 -
Dose-ranging Study of Tranexamic Acid in Valve Surgery
|
N/A | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A | |
Completed |
NCT01136590 -
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery
|
Phase 4 | |
Completed |
NCT01085006 -
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
|
Phase 1/Phase 2 | |
Completed |
NCT00700141 -
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
|
N/A | |
Completed |
NCT00375466 -
Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.
|
N/A | |
Completed |
NCT00479362 -
Anticoagulant Therapy During Pacemaker Implantation
|
Phase 4 | |
Completed |
NCT00147420 -
RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet
|
N/A | |
Recruiting |
NCT05945680 -
Tranexamic Acid in Breast Esthetic Surgery.
|
Phase 4 | |
Completed |
NCT03273322 -
Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure
|
Phase 2/Phase 3 | |
Withdrawn |
NCT05672407 -
The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
|
Phase 4 |