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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01082991
First received: March 5, 2010
Last updated: September 4, 2013
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Heart Arrest
Other: Preemptive Rapid Response Team intervention
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Strategies to Predict and Prevent In-Hospital Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Mortality and cardiac arrest rates [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Cost [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Time to ICU transfer [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20768
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082991

Contacts
Contact: Deborah L Walsh, MS, RN 7737028828 dwalsh@medicine.bsd.uchicago.edu
Contact: Dana P Edelson, MD, MS 773834-2191 dperes@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Deborah L Walsh, MS, RN    773-702-8828    dwalsh@medicine.bsd.uchicago.edu   
Contact: Dana P Edelson, MD, MS    7738342191    dperes@medicine.bsd.uchicago.edu   
Principal Investigator: Dana P Edelson, MD, MS         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Dana P Edelson, MD, MS University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01082991     History of Changes
Other Study ID Numbers: 15723A, 1K23HL097157-01
Study First Received: March 5, 2010
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014