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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL141608-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | This arm will have no interventions and standard of care practices will be in place. | |
| Default order set | Active Comparator | This arm will have the default order set implementation strategy |
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| Physician-targeted accountable justification | Active Comparator | This arm will have the physician-targeted accountable justification implementation strategy |
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| Default order set + RT-targeted accountable justification | Active Comparator | This arm will have the default order set and respiratory therapist-targeted accountable justification |
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| Physician-targeted accountable justification + RT-targeted accountable justification | Active Comparator | This arm will have the default order set and respiratory therapist-targeted accountable justification |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Default order set | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity to LPV | percentage of time that a patient is exposed to tidal volume <6.5 cc/kg ideal body weight | up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meeta Kerlin, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princeton Medical Center | Plainsboro | New Jersey | 08536 | United States | ||
| Hospital of the University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42098760 | Derived | Kerlin MP, Harhay MO, Li F, Small DS, Lu Y, Wang W, Fuchs BD, Mikkelsen ME, Tran T, Belk A, Silvestri JA, Klaiman T, Scott S, Levy E, Sjoding MW, Kohn R, Roberts KJ, Beidas RS, Halpern SD. Nudging implementation of low tidal volume ventilation: a stepped wedge, cluster randomized trial. Implement Sci. 2026 May 7;21(1):40. doi: 10.1186/s13012-026-01500-8. | |
| 34376233 | Derived | Kerlin MP, Small D, Fuchs BD, Mikkelsen ME, Wang W, Tran T, Scott S, Belk A, Silvestri JA, Klaiman T, Halpern SD, Beidas RS. Implementing nudges to promote utilization of low tidal volume ventilation (INPUT): a stepped-wedge, hybrid type III trial of strategies to improve evidence-based mechanical ventilation management. Implement Sci. 2021 Aug 10;16(1):78. doi: 10.1186/s13012-021-01147-7. |
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Individual participant data that underlie published results will be made available to other researchers, after deidentification.
Data will be available beginning 9 months after publication and up to 36 months following publication. After 36 months the data will be available in our University's data warehouse but without support, except for deposited metadata.
Proposals for data use will be reviewed by Principal Investigator and independent review boards (such as Institutional Review Board and Data Safety and Monitoring Board). Approved data requestors will need to sign data use agreements to access and use data
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| ID | Title | Description |
|---|---|---|
| FG000 | Strategy A+C, Wedge 1 (ICU #1) | 3 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 milliliters per kilogram predicted body weight [cc/kg PBW]that can be opted out of by the ordering clinician at any time with a click), followed by 18 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Step 1: 2/22/2021 to 5/16/2021 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2023 | Jun 17, 2024 |
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| Physician-targeted accountable justification | Behavioral | 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. |
|
| Respiratory therapist (RT)-targeted accountable justification | Behavioral | 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. |
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| 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. | 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) | 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) | within 24 hours of initiation of mechanical ventilation in a study ICU |
| Hospital Mortality | All-cause mortality occurring during hospitalization. | 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 | 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 | 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 | 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 | 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. | 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. | 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. | up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICU |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Chester County Hospital | West Chester | Pennsylvania | 19380 | United States |
| FG001 | Strategy B+C, Wedge 1 (ICU #2) | 3 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 18 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| FG002 | Strategy A+C, Wedge 2 (ICU #3) | 6 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 15 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| FG003 | Strategy B+C, Wedge 2 (ICU #4) | 6 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 15 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg PBW into the flowsheet). |
| FG004 | Strategy A+C, Wedge 3 (ICU #5) | 9 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 12 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| FG005 | Strategy B+C, Wedge 3 (ICU #6) | 9 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 12 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| FG006 | Strategy A+C, Wedge 4 (ICU #7) | 12 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 9 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| FG007 | Strategy B+C, Wedge 4 (ICU #8) | 12 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 9 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| FG008 | Strategy A+C, Wedge 5 (ICU #9) | 15 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 6 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| FG009 | Strategy B+C, Wedge 5 (ICU #10) | 15 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 6 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| FG010 | Strategy A+C, Wedge 6 (ICU #11) | 18 months of usual care followed by 6 months with Strategy A alone (a nudge embedded in the order panel including pre-specified settings for mechanical ventilation including tidal volume of 6 cc/kg PBW that can be opted out of by the ordering clinician at any time with a click), followed by 3 months with Strategy A+C (strategy A as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| FG011 | Strategy B+C, Wedge 6 (ICU #12) | 18 months of usual care followed by 6 months with Strategy B alone (a nudge embedded in the order panel requiring a free-text justification if a tidal volume greater than 6.5 cc/kg PBW is ordered), followed by 3 months with Strategy B+C (strategy B as above combined with nudge that requires that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6.5 cc/kg PBW into the flowsheet). |
| COMPLETED |
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| NOT COMPLETED |
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| Step 2: 5/17/2021 to 8/15/2021 |
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| Step 3: 8/16/2021 to 11/14/2021 |
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| Step 4: 11/15/2021 to 2/20/2022 |
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| Step 5: 2/21/2022 to 5/15/2022 |
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| Step 6: 5/16/2022 to 8/21/2022 |
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| Step 7: 8/22/2022 to11/20/2022 |
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| Step 8: 11/21/2022 to 2/19/2023 |
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| Step 9: 2/20/2023 to 5/15/2023 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fidelity to LPV | percentage of time that a patient is exposed to tidal volume <6.5 cc/kg ideal body weight | Posted | Median | Inter-Quartile Range | Percentage of time during first 72 hours | up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilation |
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| 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. | Posted | Median | Inter-Quartile Range | hours | from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days) |
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| 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. | Posted | Median | Inter-Quartile Range | hours | from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days) |
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| 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) | Posted | Count of Participants | Participants | within 24 hours of initiation of mechanical ventilation in a study ICU |
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| 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) | Posted | Count of Participants | Participants | within 24 hours of initiation of mechanical ventilation in a study ICU |
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| Secondary | Hospital Mortality | All-cause mortality occurring during hospitalization. | Posted | Count of Participants | Participants | 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. |
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| Secondary | ICU-free Days | days alive and not admitted to an ICU; composite of ICU length of stay and death | Posted | Median | Inter-Quartile Range | days | from time of first eligibility to 30 days |
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| Secondary | Hospital Free Days | days alive and not admitted to a hospital;composite of hospital length of stay and death | Posted | Median | Inter-Quartile Range | days | from time of first eligibility to 30 days |
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| Secondary | Ventilator Free Days | days alive and not on mechanical ventilation; composite of ventilator free days and death | Posted | Median | Inter-Quartile Range | days | from time of first eligiblity to 30 days |
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| Secondary | Hospital Discharge Disposition | Location to which the patient was discharged after the end of the hospital admission | Posted | Count of Participants | Participants | At the time of discharge from the hospital, up to 720 hours (30 days) after initiation of mechanical ventilation in a study ICU |
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| 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. | Posted | Median | Inter-Quartile Range | percentage of time | up to 72 hours, from the initiation to the discontinuation of mechanical ventilation in the ICU |
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| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 72 hours, from initiation to discontinuation of mechanical ventilation in a study ICU |
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| 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. | Posted | Count of Participants | Participants | up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICU |
|
All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.
Serious adverse events included (1) life threatening acidemia (pH <7.10), (2) mortality, or (3) cardiac arrest, all of which commonly occur in critically ill mechanically ventilated patients. Events were identified through daily reports reviewed by research coordinators and clinical experts to determine treatment-relatedness. Because this determination could be uncertain, we specified a priori that we would report all events in control and intervention groups for comparative purposes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | 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 | 844 | 2,976 | 95 | 2,976 | 0 | 2,976 |
| EG001 | 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. | 264 | 956 | 24 | 956 | 0 | 956 |
| EG002 | 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. | 231 | 734 | 39 | 734 | 0 | 734 |
| EG003 | 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. | 367 | 1,480 | 42 | 1,480 | 0 | 1,480 |
| EG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the physician-targeted accountable justification order set and respiratory therapist-targeted accountable justification flowsheet 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. | 394 | 1,196 | 64 | 1,196 | 0 | 1,196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| life-threatening acidemia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | pH less than 7.10 in the first blood gas after study enrollment, within 24 hours |
| |
| mortality within 24 hours | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | All-cause mortality within 24 hours of study enrollment |
| |
| cardiac arrest within 24 hours | Cardiac disorders | Systematic Assessment | cardiac arrest, within 24 hours of study enrollment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meeta Prasad Kerlin (PI) | University of Pennsylvania | 215-746-0446 | prasadm@pennmedicine.upenn.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2024 | Jun 17, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 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. |
| OG003 | 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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| 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. |
| OG003 | Default Order Set + RT-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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| OG003 | Default Order Set + RT-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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| OG003 | Default Order Set + RT-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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| OG003 | 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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| OG003 | 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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| OG003 | 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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| OG003 | 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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| OG003 | 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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| 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. |
| OG003 | Default Order Set + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
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. |
| OG003 | 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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
|
|
| OG002 |
| 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. |
| OG003 | 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. |
| OG004 | Physician-targeted Accountable Justification + RT-targeted Accountable Justification | This arm will have the default order set and respiratory therapist-targeted accountable justification 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. 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. |
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