Acute Respiratory Distress Syndrome, Acute Respiratory Failure, ARDS, Critical Illness
Conditions
Keywords
mechanical ventilation, lung-protective ventilation
Brief summary
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.
Detailed 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 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.
Interventions
BEHAVIORALDefault order set
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.
BEHAVIORALPhysician-targeted accountable justification
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.
BEHAVIORALRespiratory therapist (RT)-targeted accountable justification
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 and over; AND 2. Admission to 1 of the 12 participating ICUs; AND 3. Undergoing mechanical ventilation
Exclusion criteria
1. The episode of MV lasts less than 12 hours, because we believe that the evidence-based practice may not apply to these patients nor alter their outcomes. 2. The patient is on minimal settings for the entirety of MV, defined as a spontaneous mode (e.g., pressure support ventilation) with pressure support \<10 Centimeters of Water Column (cmH2O), AND positive end-expiratory pressure (PEEP) \<8 cmH20, AND fraction of inspired oxygen (FiO2) \<50%, because the clinical significance of spontaneous tidal volumes is unknown and low tidal volumes may not be beneficial or desirable. 3. Goals of care are documented as comfort measures only (as identified through their code status field in the EHR) during the first 72 hours during episode of MV, because mechanical ventilation is managed differently during care focused exclusively on comfort and low tidal volume ventilation may not be appropriate, nor would it likely influence clinical outcomes. 4. There is no height documented in the EHR at the time of initiation of MV, because we will be unable to estimate ideal body weight, a necessary parameter to calculate the primary outcome, and because they will not receive the interventions. 5. The height documented is less than 4 feet, because the formula for ideal body weight does not hold true below this height.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity to LPV | up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilation | percentage of time that a patient is exposed to tidal volume \<6.5 cc/kg ideal body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Duration of Exposure to Tidal Volume >10 cc/kg PBW | from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days) | 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. |
| Initial Tidal Volume Administered | within 24 hours of initiation of mechanical ventilation in a study ICU | 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) |
| Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | within 24 hours of initiation of mechanical ventilation in a study ICU | Binary variable for whether initial plateau pressure (Pplat) \> 30 cm H2O (first documented value after initiation of mechanical ventilation in a study ICU) |
| Hospital Mortality | 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. | All-cause mortality occurring during hospitalization. |
| ICU-free Days | from time of first eligibility to 30 days | days alive and not admitted to an ICU; composite of ICU length of stay and death |
| Total Duration of Exposure to Tidal Volume >8 cc/kg PBW | from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days) | 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. |
| Ventilator Free Days | from time of first eligiblity to 30 days | days alive and not on mechanical ventilation; composite of ventilator free days and death |
| Hospital Discharge Disposition | At the time of discharge from the hospital, up to 720 hours (30 days) after initiation of mechanical ventilation in a study ICU | Location to which the patient was discharged after the end of the hospital admission |
| Early Deep Sedation | up to 72 hours, from the initiation to the discontinuation of mechanical ventilation in the ICU | 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. |
| Average Sedation Intensity Within the First 72 Hours | Up to 72 hours, from initiation to discontinuation of mechanical ventilation in a study ICU | 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. |
| Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICU | 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. |
| Hospital Free Days | from time of first eligibility to 30 days | days alive and not admitted to a hospital;composite of hospital length of stay and death |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (Baseline) This arm will have no interventions and standard of care practices will be in place.
Standard of Care: ICUs and clinicians will deliver standard of care to patients with no intervention | 2,976 |
| Default Order Set This arm will have the default order set implementation strategy
Default order set: 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 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values. | 956 |
| Physician-targeted Accountable Justification This arm will have the physician-targeted accountable justification implementation strategy
Physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, 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. | 734 |
| Default Order Set + RT-targeted Accountable Justification This arm will have the default order set and physician-targeted accountable justification
Default order set: 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 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy. | 1,480 |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification This arm will have both the physician-targeted and respiratory therapist-targeted accountable justification interventions
Physician-targeted accountable justification: When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, 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.
RT-targeted accountable justification: This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy. | 1,196 |
| Total | 7,342 |
Baseline characteristics
| Characteristic | Standard of Care (Baseline) | Default Order Set | Physician-targeted Accountable Justification | Default Order Set + RT-targeted Accountable Justification | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 62 years | 61 years | 64 years | 63 years | 63 years | 63 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 13 Participants | 11 Participants | 6 Participants | 2 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2853 Participants | 915 Participants | 710 Participants | 1452 Participants | 1186 Participants | 7116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 98 Participants | 28 Participants | 13 Participants | 22 Participants | 8 Participants | 169 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 15 Participants |
| Race (NIH/OMB) Asian | 96 Participants | 32 Participants | 43 Participants | 37 Participants | 60 Participants | 268 Participants |
| Race (NIH/OMB) Black or African American | 1063 Participants | 328 Participants | 250 Participants | 521 Participants | 407 Participants | 2569 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 26 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 4 Participants | 4 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 304 Participants | 132 Participants | 51 Participants | 241 Participants | 115 Participants | 843 Participants |
| Race (NIH/OMB) White | 1496 Participants | 455 Participants | 381 Participants | 671 Participants | 607 Participants | 3610 Participants |
| Region of Enrollment United States | 2976 participants | 956 participants | 734 participants | 1480 participants | 1196 participants | 7342 participants |
| Sex: Female, Male Female | 1199 Participants | 336 Participants | 325 Participants | 569 Participants | 512 Participants | 2941 Participants |
| Sex: Female, Male Male | 1777 Participants | 620 Participants | 409 Participants | 911 Participants | 684 Participants | 4401 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 844 / 2,976 | 264 / 956 | 231 / 734 | 367 / 1,480 | 394 / 1,196 |
| other Total, other adverse events | 0 / 2,976 | 0 / 956 | 0 / 734 | 0 / 1,480 | 0 / 1,196 |
| serious Total, serious adverse events | 95 / 2,976 | 24 / 956 | 39 / 734 | 42 / 1,480 | 64 / 1,196 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Fidelity to LPV | 43.3 Percentage of time during first 72 hours |
| Default Order Set | Fidelity to LPV | 19.1 Percentage of time during first 72 hours |
| Physician-targeted Accountable Justification | Fidelity to LPV | 83.9 Percentage of time during first 72 hours |
| Default Order Set + RT-targeted Accountable Justification | Fidelity to LPV | 31.0 Percentage of time during first 72 hours |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Fidelity to LPV | 67.8 Percentage of time during first 72 hours |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Average Sedation Intensity Within the First 72 Hours | -2.09 score on a scale |
| Default Order Set | Average Sedation Intensity Within the First 72 Hours | -2.56 score on a scale |
| Physician-targeted Accountable Justification | Average Sedation Intensity Within the First 72 Hours | -1.8 score on a scale |
| Default Order Set + RT-targeted Accountable Justification | Average Sedation Intensity Within the First 72 Hours | -2.59 score on a scale |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Average Sedation Intensity Within the First 72 Hours | -1.99 score on a scale |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Yes | 594 Participants |
| Standard of Care | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Missing | 20 Participants |
| Standard of Care | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | No | 2362 Participants |
| Default Order Set | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | No | 687 Participants |
| Default Order Set | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Yes | 264 Participants |
| Default Order Set | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Missing | 5 Participants |
| Physician-targeted Accountable Justification | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | No | 609 Participants |
| Physician-targeted Accountable Justification | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Yes | 119 Participants |
| Physician-targeted Accountable Justification | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Missing | 6 Participants |
| Default Order Set + RT-targeted Accountable Justification | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Yes | 392 Participants |
| Default Order Set + RT-targeted Accountable Justification | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Missing | 5 Participants |
| Default Order Set + RT-targeted Accountable Justification | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | No | 1083 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | No | 962 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Yes | 229 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation | Missing | 5 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Early Deep Sedation | 33 percentage of time |
| Default Order Set | Early Deep Sedation | 33 percentage of time |
| Physician-targeted Accountable Justification | Early Deep Sedation | 33 percentage of time |
| Default Order Set + RT-targeted Accountable Justification | Early Deep Sedation | 33 percentage of time |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Early Deep Sedation | 33 percentage of time |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Hospital Discharge Disposition | SNF | 372 Participants |
| Standard of Care | Hospital Discharge Disposition | REHAB | 459 Participants |
| Standard of Care | Hospital Discharge Disposition | OTHER | 26 Participants |
| Standard of Care | Hospital Discharge Disposition | EXPIRED | 844 Participants |
| Standard of Care | Hospital Discharge Disposition | ACH | 188 Participants |
| Standard of Care | Hospital Discharge Disposition | HOME | 954 Participants |
| Standard of Care | Hospital Discharge Disposition | HOSPICE | 133 Participants |
| Default Order Set | Hospital Discharge Disposition | HOSPICE | 30 Participants |
| Default Order Set | Hospital Discharge Disposition | HOME | 310 Participants |
| Default Order Set | Hospital Discharge Disposition | ACH | 63 Participants |
| Default Order Set | Hospital Discharge Disposition | SNF | 104 Participants |
| Default Order Set | Hospital Discharge Disposition | OTHER | 8 Participants |
| Default Order Set | Hospital Discharge Disposition | EXPIRED | 264 Participants |
| Default Order Set | Hospital Discharge Disposition | REHAB | 177 Participants |
| Physician-targeted Accountable Justification | Hospital Discharge Disposition | HOME | 228 Participants |
| Physician-targeted Accountable Justification | Hospital Discharge Disposition | SNF | 114 Participants |
| Physician-targeted Accountable Justification | Hospital Discharge Disposition | ACH | 63 Participants |
| Physician-targeted Accountable Justification | Hospital Discharge Disposition | EXPIRED | 231 Participants |
| Physician-targeted Accountable Justification | Hospital Discharge Disposition | HOSPICE | 37 Participants |
| Physician-targeted Accountable Justification | Hospital Discharge Disposition | OTHER | 9 Participants |
| Physician-targeted Accountable Justification | Hospital Discharge Disposition | REHAB | 52 Participants |
| Default Order Set + RT-targeted Accountable Justification | Hospital Discharge Disposition | EXPIRED | 367 Participants |
| Default Order Set + RT-targeted Accountable Justification | Hospital Discharge Disposition | HOSPICE | 50 Participants |
| Default Order Set + RT-targeted Accountable Justification | Hospital Discharge Disposition | ACH | 108 Participants |
| Default Order Set + RT-targeted Accountable Justification | Hospital Discharge Disposition | REHAB | 270 Participants |
| Default Order Set + RT-targeted Accountable Justification | Hospital Discharge Disposition | OTHER | 5 Participants |
| Default Order Set + RT-targeted Accountable Justification | Hospital Discharge Disposition | SNF | 192 Participants |
| Default Order Set + RT-targeted Accountable Justification | Hospital Discharge Disposition | HOME | 488 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Hospital Discharge Disposition | EXPIRED | 394 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Hospital Discharge Disposition | REHAB | 123 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Hospital Discharge Disposition | OTHER | 12 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Hospital Discharge Disposition | HOSPICE | 43 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Hospital Discharge Disposition | ACH | 100 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Hospital Discharge Disposition | SNF | 170 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Hospital Discharge Disposition | HOME | 354 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Hospital Free Days | 2 days |
| Default Order Set | Hospital Free Days | 0 days |
| Physician-targeted Accountable Justification | Hospital Free Days | 0.5 days |
| Default Order Set + RT-targeted Accountable Justification | Hospital Free Days | 2 days |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Hospital Free Days | 0 days |
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Hospital Mortality | 977 Participants |
| Default Order Set | Hospital Mortality | 294 Participants |
| Physician-targeted Accountable Justification | Hospital Mortality | 268 Participants |
| Default Order Set + RT-targeted Accountable Justification | Hospital Mortality | 417 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Hospital Mortality | 437 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | ICU-free Days | 18 days |
| Default Order Set | ICU-free Days | 16 days |
| Physician-targeted Accountable Justification | ICU-free Days | 18.5 days |
| Default Order Set + RT-targeted Accountable Justification | ICU-free Days | 19 days |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | ICU-free Days | 18 days |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | >30 | 126 Participants |
| Standard of Care | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | missing | 540 Participants |
| Standard of Care | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | < 30 | 2310 Participants |
| Default Order Set | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | < 30 | 806 Participants |
| Default Order Set | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | >30 | 26 Participants |
| Default Order Set | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | missing | 124 Participants |
| Physician-targeted Accountable Justification | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | < 30 | 507 Participants |
| Physician-targeted Accountable Justification | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | >30 | 37 Participants |
| Physician-targeted Accountable Justification | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | missing | 190 Participants |
| Default Order Set + RT-targeted Accountable Justification | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | >30 | 34 Participants |
| Default Order Set + RT-targeted Accountable Justification | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | missing | 259 Participants |
| Default Order Set + RT-targeted Accountable Justification | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | < 30 | 1187 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | < 30 | 903 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | >30 | 43 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O) | missing | 250 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Initial Tidal Volume Administered | > 6.5 cc/kg PBW | 1628 Participants |
| Standard of Care | Initial Tidal Volume Administered | < or equal to 6.5 cc/kg PBW | 1348 Participants |
| Default Order Set | Initial Tidal Volume Administered | > 6.5 cc/kg PBW | 539 Participants |
| Default Order Set | Initial Tidal Volume Administered | < or equal to 6.5 cc/kg PBW | 417 Participants |
| Physician-targeted Accountable Justification | Initial Tidal Volume Administered | > 6.5 cc/kg PBW | 347 Participants |
| Physician-targeted Accountable Justification | Initial Tidal Volume Administered | < or equal to 6.5 cc/kg PBW | 387 Participants |
| Default Order Set + RT-targeted Accountable Justification | Initial Tidal Volume Administered | < or equal to 6.5 cc/kg PBW | 658 Participants |
| Default Order Set + RT-targeted Accountable Justification | Initial Tidal Volume Administered | > 6.5 cc/kg PBW | 822 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Initial Tidal Volume Administered | > 6.5 cc/kg PBW | 562 Participants |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Initial Tidal Volume Administered | < or equal to 6.5 cc/kg PBW | 634 Participants |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Total Duration of Exposure to Tidal Volume >10 cc/kg PBW | 0 hours |
| Default Order Set | Total Duration of Exposure to Tidal Volume >10 cc/kg PBW | 0 hours |
| Physician-targeted Accountable Justification | Total Duration of Exposure to Tidal Volume >10 cc/kg PBW | 0 hours |
| Default Order Set + RT-targeted Accountable Justification | Total Duration of Exposure to Tidal Volume >10 cc/kg PBW | 0 hours |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Total Duration of Exposure to Tidal Volume >10 cc/kg PBW | 0 hours |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Total Duration of Exposure to Tidal Volume >8 cc/kg PBW | 0.08 hours |
| Default Order Set | Total Duration of Exposure to Tidal Volume >8 cc/kg PBW | 0.51 hours |
| Physician-targeted Accountable Justification | Total Duration of Exposure to Tidal Volume >8 cc/kg PBW | 0 hours |
| Default Order Set + RT-targeted Accountable Justification | Total Duration of Exposure to Tidal Volume >8 cc/kg PBW | 0.37 hours |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Total Duration of Exposure to Tidal Volume >8 cc/kg PBW | 0.09 hours |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Ventilator Free Days | 22 days |
| Default Order Set | Ventilator Free Days | 23 days |
| Physician-targeted Accountable Justification | Ventilator Free Days | 21 days |
| Default Order Set + RT-targeted Accountable Justification | Ventilator Free Days | 25 days |
| Physician-targeted Accountable Justification + RT-targeted Accountable Justification | Ventilator Free Days | 21.5 days |