This study is a large pragmatic stepped-wedge trial of electronic health record (EHR)-based implementation strategies informed by behavioral economic principles to increase lung-protective ventilation (LPV) utilization among all mechanically ventilated (MV), adult patients. The study will compare the standard approach to managing MV across 12 study Intensive Care Units (ICUs) within University of Pennsylvania Health System (UPHS) versus interventions prompting physicians and respiratory therapists (RTs) to employ LPV settings promote LPV utilization among all MV patients.
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 intensive care units (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 accountable justification strategy targeting respiratory therapists (RT; 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 6-month observational period where trial monitoring will cease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
7,342
With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 milliliters per kilogram of predicted body weight (cc/kg PBW; as determined by each patient's height and gender). The physician will have the option to opt out of any of the specified LPV settings and select other values.
When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg PBW, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
If an RT enters a tidal volume in a flowsheet documentation field value greater than 6 cc/kg PBW, an alert will appear requiring them to enter a reason for entering a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The RT will not be able to save the documentation in the EHR until after a response is entered.
Princeton Medical Center
Plainsboro, New Jersey, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Chester County Hospital
West Chester, Pennsylvania, United States
Fidelity to LPV
percentage of time that a patient is exposed to tidal volume \<6.5 cc/kg ideal body weight
Time frame: up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilation
Total Duration of Exposure to Tidal Volume >8 cc/kg PBW
Total duration of exposure to tidal volume greater than 8 cc/kg PBW, in hours. The time frame for follow-up is based on the total duration of IMV during the total follow-up period of 30 days. Note it is intentionally different from the time frame of the primary outcome variable, which focuses on the initial 72 hours, as the period most likely to be influenced by the study interventions.
Time frame: from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)
Total Duration of Exposure to Tidal Volume >10 cc/kg PBW
Total duration of exposure to tidal volume greater than 10 cc/kg PBW, in hours. The time frame for follow-up is based on the total duration of IMV during the total follow-up period of 30 days. Note it is intentionally different from the time frame of the primary outcome variable, which focuses on the initial 72 hours, as the period most likely to be influenced by the study interventions.
Time frame: from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)
Initial Tidal Volume Administered
Binary variable for whether initial tidal volume (first documented value after initiation of mechanical ventilation in a study ICU) is less than or equal to 6.5 milliliters per kilogram of predicted body weight (cc/kg PBW)
Time frame: within 24 hours of initiation of mechanical ventilation in a study ICU
Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)
Binary variable for whether initial plateau pressure (Pplat) \> 30 cm H2O (first documented value after initiation of mechanical ventilation in a study ICU)
Time frame: within 24 hours of initiation of mechanical ventilation in a study ICU
Hospital Mortality
All-cause mortality occurring during hospitalization.
Time frame: All-cause mortality as a study outcome was assessed through hospital discharge, up to 720 hours (30 days); all adverse events (including mortality) were assessed though 24 hours after initiation of mechanical ventilation.
ICU-free Days
days alive and not admitted to an ICU; composite of ICU length of stay and death
Time frame: from time of first eligibility to 30 days
Hospital Free Days
days alive and not admitted to a hospital;composite of hospital length of stay and death
Time frame: from time of first eligibility to 30 days
Ventilator Free Days
days alive and not on mechanical ventilation; composite of ventilator free days and death
Time frame: from time of first eligiblity to 30 days
Hospital Discharge Disposition
Location to which the patient was discharged after the end of the hospital admission
Time frame: At the time of discharge from the hospital, up to 720 hours (30 days) after initiation of mechanical ventilation in a study ICU
Early Deep Sedation
The percentage of time during the first 72 hours of mechanical ventilation that patients were alive, in the ICU, and with Richmond Agitation-Sedation Scale (RASS) of -3 to -5 . The RASS measures a patient's depth of sedation and ranges from -5 (comatose) to +4 (combative), with a normal level of 0 (defined as "alert and calm"). Negative values indicate a patient is sedated and positive values indicate some degree of agitation.
Time frame: up to 72 hours, from the initiation to the discontinuation of mechanical ventilation in the ICU
Average Sedation Intensity Within the First 72 Hours
Average Richmond Agitation-Sedation Scale (RASS) value, weighted by duration of time at that value. The RASS measures a patient's depth of sedation and ranges from -5 (comatose) to +4 (combative), with a normal level of 0 (defined as "alert and calm"). Negative values indicate a patient is sedated and positive values indicate some degree of agitation.
Time frame: Up to 72 hours, from initiation to discontinuation of mechanical ventilation in a study ICU
Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation
Binary variable for whether a patient had Richmond Agitation-Sedation Scale (RASS) score of -3 to -5 for the entirety of the first 72 hours of mechanical ventilation. The RASS measures a patient's depth of sedation and ranges from -5 (comatose) to +4 (combative), with a normal level of 0 (defined as "alert and calm"). Negative values indicate a patient is sedated and positive values indicate some degree of agitation.
Time frame: up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICU
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