Physician-targeted accountable justification for Critical Illness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Critical Illness+6 More
Default order set - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether EHR-based interventions can increase the use of lung-protective ventilation among all mechanically ventilated patients in 12 ICUs.

Eligible Conditions
  • Critical Illness
  • Acute Respiratory Failure
  • Respiratory Distress Syndrome, Newborn

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: through time of hospital discharge, average of 264 hours

Hour 72
initial tidal volume administered
Hour 72
fidelity to LPV
Hour 72
sustainability
Hour 120
hospital mortality
Hour 264
Total number of days with acute brain dysfunction during hospitalization
total cumulative doses of sedative medications during and after mechanical ventilation
Hour 72
Duration of time exposed to plateau pressure (Pplat)>30 mmHg
Total duration of exposure to tidal volume >8 cc/kg and >10 cc/kg IBW
mechanical ventilation duration
Hour 120
ICU length of stay
Hour 264
hospital length of stay
Hour 264
hospital discharge disposition

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Physician-targeted accountable justification
1 of 5
Default order set + physician-targeted accountable justification
1 of 5
Default order set
1 of 5
Physician-targeted accountable justification + RT-targeted accountable justifica...
1 of 5
Standard of Care
1 of 5

Active Control

Non-Treatment Group

15100 Total Participants · 5 Treatment Groups

Primary Treatment: Physician-targeted accountable justification · Has Placebo Group · N/A

Physician-targeted accountable justification
Behavioral
ActiveComparator Group · 1 Intervention: physician-targeted accountable justification · Intervention Types: Behavioral
Default order set + physician-targeted accountable justificationActiveComparator Group · 2 Interventions: Default order set, physician-targeted accountable justification · Intervention Types: Behavioral, Behavioral
Default order set
Behavioral
ActiveComparator Group · 1 Intervention: Default order set · Intervention Types: Behavioral
Physician-targeted accountable justification + RT-targeted accountable justificationActiveComparator Group · 2 Interventions: RT-targeted accountable justification, physician-targeted accountable justification · Intervention Types: Behavioral, Behavioral
Standard of Care
Other
PlaceboComparator Group · 1 Intervention: Standard of Care · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through time of hospital discharge, average of 264 hours

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,580 Previous Clinical Trials
46,953,896 Total Patients Enrolled
15 Trials studying Critical Illness
3,149 Patients Enrolled for Critical Illness
University of PennsylvaniaLead Sponsor
1,822 Previous Clinical Trials
41,101,123 Total Patients Enrolled
10 Trials studying Critical Illness
10,472 Patients Enrolled for Critical Illness
Meeta Kerlin, MD, MSCEPrincipal InvestigatorUniversity of Pennsylvania

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible for admission to 1 of the 12 participating ICUs if you are in a life-threatening situation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.