Patient Acuity Rating: a Tool to Prevent In-Hospital Cardiac Arrest (PAR)
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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 |
- 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.
- 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 |
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| 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 |
| 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 | |
| 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: | Dana Peres Edelson, MD, MS, 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: | March 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Heart Arrest Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013