Cancer, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Diabetes Mellitus, Obstructive Sleep Apnea
Conditions
Keywords
Outcomes, Early warning systems, ICU transfer
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).
Interventions
OTHEREarly warning system monitoring.
General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system monitoring developed at Washington University.
OTHERroutine care
Sponsors
The Foundation for Barnes-Jewish Hospital
American College of Chest Physicians
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU Transfer | Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days. | Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Patients will be asessed for the secondary outcome measure during an average of 28 days.. | Death during hospitalization will be used to determine the presence of this outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Routine Care General hospital ward patients will receive routine care.
routine care | 285 |
| Intervention Arm Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration.
Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University. | 286 |
| Total | 571 |
Baseline characteristics
| Characteristic | Routine Care | Intervention Arm | Total |
|---|---|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 15.4 | 63.7 years STANDARD_DEVIATION 16 | 63.3 years STANDARD_DEVIATION 15.5 |
| Region of Enrollment United States | 285 participants | 286 participants | 571 participants |
| Sex: Female, Male Female | 140 Participants | 132 Participants | 272 Participants |
| Sex: Female, Male Male | 145 Participants | 154 Participants | 299 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 285 | 0 / 286 |
| serious Total, serious adverse events | 0 / 285 | 0 / 286 |
Outcome results
Primary
ICU Transfer
Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.
Time frame: Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Routine Care | ICU Transfer | 52 participants |
| Intervention Arm | ICU Transfer | 51 participants |
Secondary
Mortality
Death during hospitalization will be used to determine the presence of this outcome.
Time frame: Patients will be asessed for the secondary outcome measure during an average of 28 days..