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

Strategies to Predict and Prevent In-Hospital Cardiac Arrest

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Arrest
• Intervention / Treatment: Other: Preemptive Rapid Response Team intervention

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: prevention

Other: Preemptive 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of stay	15 months
Cost	15 months
Time to ICU transfer	15 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Dana P Edelson, MD, MS, University of Chicago

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: March 5, 2010
• First Submitted That Met QC Criteria: March 8, 2010
• First Posted (Estimate): March 9, 2010

Study Record Updates

• Last Update Posted (Estimate): April 7, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 15723A; 1K23HL097157-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No