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

Early Phase 1

Withdrawn

• Conditions: Heart Arrest
• Interventions: Other: Preemptive Rapid Response Team intervention

• Registration Number: NCT01082991
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-06
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prevention	Preemptive Rapid Response Team intervention	-

Primary Outcome Measures

Name	Time	Method
Mortality and cardiac arrest rates	15 months	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.

Secondary Outcome Measures

Name	Time	Method
Length of stay	15 months
Cost	15 months
Time to ICU transfer	15 months

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States