Congestive Heart FailureNCT01741480
Early Warning System
A study testing Early warning system monitoring. and routine care in people with Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, run by Washington University School of Medicine at 1 site in United States.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Cancer
- What is being tested?
- Early warning system monitoring. and routine care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 571 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to May 2013
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized on the General Hospitals Wards of Barnes-Jewish Hospital.
Who cannot join
- Patients with a do-not-resuscitate order,
- Patients not expected to survive their hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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:
Read the 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:
- 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.
- 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.
- 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.
- 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).
- Conditions
- Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Cancer, Diabetes Mellitus, Obstructive Sleep Apnea
- Being tested
- Early warning system monitoring., routine care
- Keywords
- Outcomes, Early warning systems, ICU transfer
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Neoplasms, Diabetes Mellitus, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early warning system monitoring.Other
General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system monitoring developed at Washington University.
routine careOther
| Study group | Role | What they receive |
|---|---|---|
| Routine care | Placebo comparator | General hospital ward patients will receive routine care. Receives: Other: routine care |
| Intervention arm | Experimental | The intervention with early warning system monitoring is to have the rapid response team assess the patients real-time. Receives: Other: Early warning system monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Transfer
Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.
Measured: Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.
Secondary outcomes (1)
Mortality
Death during hospitalization will be used to determine the presence of this outcome.
Measured: Patients will be asessed for the secondary outcome measure during an average of 28 days..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
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.
- Other trials for Congestive Heart FailureStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital, American College of Chest Physicians
- Responsible party
- Sponsor
- Investigators
- Marin Kollef, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741480
- Sponsor's protocol ID
- 201210003
- Status last verified
- Apr 2022
- First submitted
- 27 Nov 2012
- Last updated
- 11 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01741480
- Acronym / sponsor ID
- 201210003
- Conditions
- Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Cancer, Diabetes Mellitus, Obstructive Sleep Apnea
- Keywords
- Outcomes, Early warning systems, ICU transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital, American College of Chest Physicians
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Posted 26 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care | Placebo comparator | Other: routine careGeneral hospital ward patients will receive routine care. |
| Intervention arm | Experimental | Other: Early warning system monitoring.The intervention with early warning system monitoring is to have the rapid response team assess the patients real-time. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients hospitalized on the General Hospitals Wards of Barnes-Jewish Hospital.
Key exclusion criteria (2 listed)
- Patients with a do-not-resuscitate order,
- Patients not expected to survive their hospitalization.
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 |
|---|---|---|
| Early 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. | Other | Intervention arm |
| routine care | Other | Routine care |
Primary outcome
ICU Transfer
Time frame: 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.
1 secondary outcome
Mortality
Time frame: Patients will be asessed for the secondary outcome measure during an average of 28 days..
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marin Kollef, 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 Early warning system monitoring. and routine care in people with Congestive Heart Failure and Chronic Obstructive Pulmonary Disease, 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 2 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 11 May 2022. 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. Some participants in this study may receive a placebo. 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 26 Jul 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?
ICU Transfer (time frame: Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2022.