Using a Remote Patient Monitoring Alert System to Improve Care

NCT02933840 | Withdrawn

• 1 other identifier: 2016P002227
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Mortality

  Whether a patient experiences death during their hospitalization.

  One year

• Transfer to the ICU

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

  One year

• Cardiac arrest

  Whether the patient experiences a cardiac arrest during their hospitalization.

  One year

• Rapid response team called

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

  One year

Secondary Outcomes (15)

• Time to ordering of blood

  One year

• Time to ordering of fluids or vasopressors

  One year

• Time to ordering of diuretics, NIPPV, or intubation

  One year

• Time to ordering of nodal blocking agent

  One year

• Time to ordering of insulin

  One year

Study Arms (2)

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.

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.

Interventions

AlertWatch 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.

AlertWatch

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Admitted to service other than orthopedic trauma surgery

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aalok V Agarwala, MD, MBA

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of General Surgery Anesthesia, Associate Director of Quality and Safety

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share