Clinical trial NCT01741480: Early Warning System
Official title: Comparing an Early Warning Alert With a Standardized Triage Intervention to Standard Care for the Management of Hospitalized Patients on General Hospital Wards.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Cancer
Diabetes Mellitus
Obstructive Sleep Apnea
Keywords: Outcomes
Early warning systems
ICU transfer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
name: American College of Chest Physicians
First posted: 2012-12-05
Enrollment: 571
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will begin in 2013 whereby patients having an early warning system (EWS) alert will be randomized to be seen by the rapid response team (RRT) for triage versus usual care. A RRT is usually made up of a nurse and/or a physician who respond to a requested activation of the RRT (called an "ACT"). The intervention will occur as follows:

Detailed description: The study will begin in 2013 whereby patients having an early warning system (EWS) alert will be randomized to be seen by the rapid response team (RRT) for triage versus usual care. A RRT is usually made up of a nurse and/or a physician who respond to a requested activation of the RRT (called an "ACT"). The intervention will occur as follows:

1. Real-time monitoring of the eight general hospital wards (GHWs)((10100, 10200, 11100,11200, 12100, 12200, 14400, 14500)will occur 24 hours daily. Through multiple past collaborative efforts and studies involving interventions at BJH, informatics personnel have already demonstrated that they can accomplish this task using their computing and algorithmic resources. The prediction tool (PT) employed is a validated PT aimed at identifying any form of clinical deterioration occurring on a GHW requiring ICU transfer or leading to patient death.
2. Patients meeting the prediction criteria for an increased risk of clinical deterioration will be identified on the GHWs. An automated text message will be generated that provides the patient's name, their room number, the date and time of the message, and text indicating that they meet the criteria for risk of deterioration. Messages will only be generated for patients assigned to the intervention group.
3. The EWS text message will be sent to the on-call RRT nurse's phone. These are phones that are transferred from one RRT nurse to the other as changes of shift occur. It is their primary means of communicating with the hospital.
4. The RRT nurse for the intervention patients will go into the flagged patient's room within 10 to 15 minutes of receiving the message and perform a clinical assessment. Based on the RRT nurse's assessment either no additional action need occur or he/she will call either the physician on duty or activate an ACT as well as apply the "four D's", which was internally established at Barnes-Jewish Hospital (BJH) for treatment of patients on GHWs identified to have impending clinical deterioration. The four "D's" refer to the following: Discuss level of care, Drugs for treatment (e.g., antibiotics), Diagnostics (lab tests, cultures), and Damage control (e.g., use of intravenous fluids, oxygen).

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized on the General Hospitals Wards of Barnes-Jewish Hospital.

Exclusion Criteria:

* Patients with a do-not-resuscitate order,
* Patients not expected to survive their hospitalization.

Primary outcomes:
measure: ICU Transfer
timeFrame: Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.
Secondary outcomes:
measure: Mortality
timeFrame: Patients will be asessed for the secondary outcome measure during an average of 28 days..
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Marin Kollef, MD
role: PRINCIPAL_INVESTIGATOR
References: