Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Respiratory Distress Syndrome
  • Acute Respiratory Failure
  • ARDS
  • Critical Illness
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

Description

The study is a 5-arm, stepped-wedge cluster randomized trial of electronic health record (EHR)-based implementation strategies set in 12 community and academic ICUs in 5 hospitals of UPHS all currently using an EHR-based algorithm to identify patients with Acute Respiratory Distress Syndrome (ARDS) ...

The study is a 5-arm, stepped-wedge cluster randomized trial of electronic health record (EHR)-based implementation strategies set in 12 community and academic ICUs in 5 hospitals of UPHS all currently using an EHR-based algorithm to identify patients with Acute Respiratory Distress Syndrome (ARDS) and prompt physicians to employ LPV will sequentially add two of three EHR-based implementation strategies to further promote LPV utilization among all MV patients. ICUs will be randomly assigned to first receive either a default order set (Strategy A) or physician-targeted accountable justification strategy (Strategy B). ICUs will be assigned to one of six wedges using computerized random-number generation, thereby determining the date on which they adopt their assigned EHR-based strategy. The first wedge will begin in the fourth month of the trial phase, so that all hospitals will contribute a minimum of 3 months of data prior to having adopted the implementation strategy. Six months after adoption, ICUs will add on an RT-targeted accountable justification strategy (Strategy C). By the end of the 27-month study period, all hospitals will have been utilizing two strategies in combination for at least 3 months. This design enables comparisons of outcomes before and after implementation within ICUs, as well as at a given point in time among ICUs which will have been randomly assigned to different strategies. During the two months after the implementation strategy rolls out in each ICU, researchers will perform semi-structured interviews of all physicians and RTs who staff study ICUs. After intervention period, there will be a 12 month observational period where ICUs will resume usual processes for care of mechanically ventilated patients and no study intervention will occur.

Tracking Information

NCT #
NCT04663802
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Meeta Kerlin, MD, MSCE University of Pennsylvania