Correlation Between Monitoring Frequency and Clinical Deterioration in Hospitalized Patients

February 6, 2015 updated by: John Asger Petersen, Bispebjerg Hospital

Acute deterioration among hospitalised patient can result in serious adverse events like cardiac arrest, unexpected death or unanticipated intensive care unit (ICU) admission. Most events are preceeded by deteriorating vital signs, and potentially avoidable.

To detect and treat hospitalised at-risk patients early an early warning score (EWS) was introduced at the investigator site. EWS measures of a number of physiological parameters that are aggregated to a common score, that directs monitoring frequency, clinical interventions and competency of the provider.

Patients with low scores (0 - 1) are monitored every 12th hour and seldom experience serious adverse events. The optimal monitoring frequency for this group is unknown, and presently based on a compromise between patient safety and work load issues.

The aim of the present study is to explore if an 8 hourly monitoring interval (intervention) is correlated with a better outcome than 12 hour intervals (control), based on the number of patients that deteriorate to a higher EWS 24 hours after hospital admission in each group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Acute deterioration among hospitalised patient can result in serious adverse events like cardiac arrest, unexpected death or unanticipated intensive care unit (ICU) admission. Most events are preceeded by deteriorating vital signs, and potentially avoidable.

To detect and treat hospitalised patients at risk of clinical deterioration in a timely manner, an early warning score (EWS) was introduced at the investigator site. EWS includes measures for respiratory rate, arterial hemoglobin oxygen saturation, pulse rate, systolic blood pressure, level of consciousness according to AVPU score, temperature, and whether a patient receives supplementary oxygen. Each vital sign can be assigned between 0 to 3 points (supplementary oxygen 0 or 2) depending on how much it deviates from a predefined threshold; the values are added to an aggregated score from 0 to 20, higher scores indicating more severe disease. An escalation protocol that directs the type of clinical response and competency of the provider according to EWS triggers was also introduced as an integrated part of the system.

Patients with low scores (0 - 1) are monitored every 12th hour and seldom experience serious adverse events. The optimal monitoring frequency for this group is unknown, and presently based on a compromise between patient safety and work load issues.

The aim of the present study is to explore if an 8 hourly monitoring interval (intervention) is correlated with a better outcome than 12 hour intervals (control) in the group of patients that have an EWS of 0 or 1 on admission. Deterioration is based on the number of patients that deteriorate to a higher EWS 24 hours after the first EWS is measured. Since serious adverse events in this population are rare the primary outcome is clinical deterioration defined as number of patients with elevated EWS >/= 2 in each group, 24 hours after admission to the hospital.

This is a cluster-randomized, non-blinded, pragmatic, interventional study of acutely admitted, adult patients to surgical or medical wards at our hospital.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first EWS on admission = 0 or 1
  • age >/ = 18 years

Exclusion Criteria:

  • chronically elevated EWS
  • terminal disease and comfort care only
  • conditions that warrant closer observation according to hospital guidelines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention (8 hours)
EWS every 8 hours
Other: Increased monitoring frequency
Active Comparator: Control (12 hours)
EWS every 12 hours
Other: Control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with an EWS >/= 2
Time Frame: 24 hours after first EWS after admission
Clinical deterioration is correlated to elevated EWS
24 hours after first EWS after admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with an aggregated score of EWS >/= 5 or >/= 7
Time Frame: 24 to 48 hours
24 to 48 hours
EWS >/ = 2
Time Frame: 48 hours
48 hours
Mortality
Time Frame: 72 hours and 30 days
72 hours and 30 days
Length of hospital stay
Time Frame: 30 days
Participants will be followed for the duration of their hospital stay, which is on average 3 - 5 days. Assessment of this data point will take place 30 days after admission.
30 days
Number of patients with an individual score of EWS >/= 3
Time Frame: 24 to 48 hours after first EWS on admission
24 to 48 hours after first EWS on admission
Number of serious adverse events during first 72 hours of admission
Time Frame: 72 hours
Serious adverse events is either cardiac arrest, unexpected death or admission to intensive care unit (ICU)
72 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of EWS measurements performed during first 48 hours of admission
Time Frame: 48 hours
48 hours
Number of MET calls during first 72 hours of admission
Time Frame: 72 hours
MET = medical emergency team
72 hours
Number of patients where escalation protocol is adhered to
Time Frame: 48 hours

To evaluate whether hospital guidelines are followed in regard to:

  • monitoring frequency
  • review by physician (for EWS >/= 3)
  • review by MET or specialist (for EWS >/= 9)
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bispebjerg Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TrygFonden, Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John A Petersen, MD, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Delstudie4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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