Using a Remote Patient Monitoring Alert System to Improve Care

NCT ID: NCT02933840

Last Updated: 2019-10-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Fractures, Bone; Cardiovascular Abnormalities; Respiratory System Abnormalities; Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

AlertWatch

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.

Group Type: EXPERIMENTAL

AlertWatch

Intervention Type: DEVICE

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.

No AlertWatch

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AlertWatch

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aalok Agarwala

Division Chief of General Surgery Anesthesia, Associate Director of Quality and Safety

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aalok V Agarwala, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

2016P002227

Identifier Type: -

Identifier Source: org_study_id