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WithdrawnNCT01082991PARUpdated Apr 7, 2016

Patient Acuity Rating: a Tool to Prevent In-Hospital Cardiac Arrest

An Early Phase 1 interventional study of Preemptive Rapid Response Team intervention in Heart Arrest, sponsored by University of Chicago. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-07.

Sponsored by University of Chicago · Early Phase 1, Interventional, and Prevention

Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to evaluate the accuracy of medical personnel in their ability to predict the likelihood of non-intensive care (ICU), ward patients to clinically deteriorate (defined as a cardiac arrest, unplanned ICU transfer, or unexpected death)via the use of a clinical judgement-based tool designed for this study, Patient Acuity Rating (PAR), to predict short-term clinical deterioration. We will compare the ability of this tool to predict clinical deterioration compared to accepted physiology-based tools and tools combining judgment and physiology as well as other markers of deterioration such as physician order changes. We will compare the sensitivity, specificity and area under the curve of these combined models to the predictive models including only physiology or clinical judgment. We will assess the correlation between specific physician orders and patient deterioration to determine whether specific clinical activities, such as emergently obtained radiology exams, predict impending deterioration. We hypothesize that PAR will be a useful tool for predicting clinical deterioration across the institution and that it will have a higher average accuracy for predicting clinical deterioration in non-ICU inpatients within 24 hours than the physiology-based tools alone. We further hypothesize that a combined metric which includes both the PAR and the individual physiologic components that comprise physiologic tools will not significantly improve prediction over the PAR alone. We further propose to use PAR to prospectively risk stratify patients for preemptive evaluation by the Rapid Response Team. We hypothesize that intervening on high risk patients by preemptively activating the hospital's Rapid Response Team (to assess and treat patients as needed) will decrease cardiac arrest rates and mortality.

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Conditions studied

  • Heart Arrest

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03

In context

Heart Arrest

965 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.

Browse Heart Arrest studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Non-ICU ward inpatients
  • PAR of 5 or above
  • Ages 18+ years

Exclusion criteria

Exclusion Criteria:

  • ICU or outpatients
  • PAR of 4 or lower
  • Ages 17 years and under
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Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    prevention

    Other: Preemptive Rapid Response Team intervention

Interventions

  • OtherPreemptive Rapid Response Team intervention

    Non-ICU inpatients will be randomized on admission to an RRT surveillance group or standard of care. Daily risk prediction scores will be collected for all non-ICU inpatients. Those with high scores, who have been randomized to the surveillance arm, will be included on a list of patients, updated daily, that the Rapid Response Team will receive, with instructions to evaluate and intervene, if required, without waiting for formal activation by the usual channels.

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What researchers measure

Primary outcomes

  1. Mortality and cardiac arrest rates

    Non-ICU ward inpatients will be randomized on admission to an RRT surveillance group or standard of care. Daily risk prediction scores will be collected for all non-ICU inpatients. Those with high scores, who have been randomized to the surveillance arm, will be included on a list of patients, updated daily, that the Rapid Response Team will receive, with instructions to evaluate and intervene, if required, without waiting for formal activation by the usual channels. Outcomes for these patients will be compared to those with comparable risk scores who were randomized to the control group.

    Time frame: 15 months

Secondary outcomes

  1. Length of stay

    Time frame: 15 months

  2. Cost

    Time frame: 15 months

  3. Time to ICU transfer

    Time frame: 15 months

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Study locations

1 site
  • University of Chicago
    Chicago, Illinois 60637, United States
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References and documents

Publications

  • Phillips AW, Yuen TC, Retzer E, Woodruff J, Arora V, Edelson DP. Supplementing cross-cover communication with the patient acuity rating. J Gen Intern Med. 2013 Mar;28(3):406-11. doi: 10.1007/s11606-012-2257-4. Epub 2012 Nov 6. PubMed 23129163 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01082991
Lead sponsor
University of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Mar 9, 2010
Start date
Oct 2009
Primary completion
Dec 2013 (estimated)
Completion
Dec 2013 (estimated)
Last update
Apr 7, 2016

Study contacts

Dana P Edelson, MD, MS
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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