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

Primary Purpose

Heart Arrest

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Preemptive Rapid Response Team intervention
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

prevention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of stay
Cost
Time to ICU transfer

Full Information

First Posted
March 5, 2010
Last Updated
April 6, 2016
Sponsor
University of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01082991
Brief Title
Patient Acuity Rating: a Tool to Prevent In-Hospital Cardiac Arrest
Acronym
PAR
Official Title
Strategies to Predict and Prevent In-Hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Arrest

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prevention
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Preemptive Rapid Response Team intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality and cardiac arrest rates
Description
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 Outcome Measure Information:
Title
Length of stay
Time Frame
15 months
Title
Cost
Time Frame
15 months
Title
Time to ICU transfer
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana P Edelson, MD, MS
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23129163
Citation
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.
Results Reference
derived

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

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