Escalation of CareNCT01280942
Early Warning System for Clinical Deterioration on General Hospital Wards
A study testing EWS Nursing Alerts and Wireless Remote Sensor in people with Escalation of Care and Cardiopulmonary Arrest, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Escalation of Care, Cardiopulmonary Arrest, Respiratory Arrest
- What is being tested?
- EWS Nursing Alerts and Wireless Remote Sensor
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,031 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital.
Who cannot join
- Minors, patients younger than 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Warning System for Clinical Deterioration on General Hospital Wards.
The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.
- Conditions
- Escalation of Care, Cardiopulmonary Arrest, Respiratory Arrest, Severe Sepsis, Septic Shock
- Being tested
- EWS Nursing Alerts, Wireless Remote Sensor
- Keywords
- clinical deterioration, detection algorithms, automated warning systems
- Medical subject headings
- Heart Arrest, Apnea, Sepsis, Shock, Septic, Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EWS Nursing AlertsBehavioural
An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.
Wireless Remote SensorDevice
A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices. |
| Nurse notification of EWS alert | Experimental | Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors. Receives: Behavioral: EWS Nursing Alerts; Device: Wireless Remote Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
Measured: Within 24 hrs of an EWS alert
Secondary outcomes (1)
Clinical Outcomes and Process Measures
length of stay
Measured: Hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Escalation of CareStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Random allocation of study wards to intervention and control, with washout period and crossover of assignment.
- Masking
- None (open label)
- Enrolment
- 20,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas C Bailey, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280942
- Sponsor's protocol ID
- 10-0514
- Other IDs
- 7322-01
- Status last verified
- Feb 2018
- First submitted
- 19 Jan 2011
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bailey TC, Chen Y, Mao Y, Lu C, Hackmann G, Micek ST, Heard KM, Faulkner KM, Kollef MH. A trial of a real-time alert for clinical deterioration in patients hospitalized on general medical wards. J Hosp Med. 2013 May;8(5):236-42. doi: 10.1002/jhm.2009. Epub 2013 Feb 25.
PubMed 23440923
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Warning System for Clinical Deterioration on General Hospital Wards.
- ClinicalTrials.gov ID
- NCT01280942
- Acronym / sponsor ID
- 10-0514
- Conditions
- Escalation of Care, Cardiopulmonary Arrest, Respiratory Arrest, Severe Sepsis, Septic Shock
- Keywords
- clinical deterioration, detection algorithms, automated warning systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,031 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Posted 14 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random allocation of study wards to intervention and control, with washout period and crossover of assignment.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices. |
| Nurse notification of EWS alert | Experimental | Behavioral: EWS Nursing Alerts, Device: Wireless Remote SensorPatients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital.
Key exclusion criteria (1 listed)
- Minors, patients younger than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EWS Nursing AlertsAn automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required. | Behavioural | Nurse notification of EWS alert |
| Wireless Remote SensorA subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood. | Device | Nurse notification of EWS alert |
Primary outcome
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
Time frame: Within 24 hrs of an EWS alert
The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
1 secondary outcome
Clinical Outcomes and Process Measures
Time frame: Hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23440923Bailey TC, Chen Y, Mao Y, Lu C, Hackmann G, Micek ST, Heard KM, Faulkner KM, Kollef MH. A trial of a real-time alert for clinical deterioration in patients hospitalized on general medical wards. J Hosp Med. 2013 May;8(5):236-42. doi: 10.1002/jhm.2009. Epub 2013 Feb 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C Bailey, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EWS Nursing Alerts and Wireless Remote Sensor in people with Escalation of Care and Cardiopulmonary Arrest, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm (time frame: Within 24 hrs of an EWS alert). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01280942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.