Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is a 5-arm, stepped-wedge cluster randomized trial of electronic health record (EHR)-based implementation strategies set in 12 community and academic ICUs in 5 hospitals of UPHS all currently using an EHR-based algorithm to identify patients with Acute Respiratory Distress Syndrome (ARDS) and prompt physicians to employ LPV will sequentially add two of three EHR-based implementation strategies to further promote LPV utilization among all MV patients. ICUs will be randomly assigned to first receive either a default order set (Strategy A) or physician-targeted accountable justification strategy (Strategy B). ICUs will be assigned to one of six wedges using computerized random-number generation, thereby determining the date on which they adopt their assigned EHR-based strategy. The first wedge will begin in the fourth month of the trial phase, so that all hospitals will contribute a minimum of 3 months of data prior to having adopted the implementation strategy. Six months after adoption, ICUs will add on an RT-targeted accountable justification strategy (Strategy C). By the end of the 27-month study period, all hospitals will have been utilizing two strategies in combination for at least 3 months. This design enables comparisons of outcomes before and after implementation within ICUs, as well as at a given point in time among ICUs which will have been randomly assigned to different strategies. During the two months after the implementation strategy rolls out in each ICU, researchers will perform semi-structured interviews of all physicians and RTs who staff study ICUs. After intervention period, there will be a 6-month observational period where trial monitoring will cease.

Official Title
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Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study

Conditions
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ARDS, Critical Illness, Acute Respiratory Distress Syndrome, Acute Respiratory Failure

Intervention / Treatment
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* Behavioral: RT-targeted accountable justification
* Behavioral: Default order set
* Behavioral: physician-targeted accountable justification
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 and over; AND Admission to 1 of the 12 participating ICUs; AND Undergoing mechanical ventilation Exclusion Criteria: 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. 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. 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. 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. The height documented is less than 4 feet, because the formula for ideal body weight does not hold true below this height.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Default order set<br>This arm will have the default order set implementation strategy | Behavioral: Default order set<br>* 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.<br>|
| Active Comparator: Physician-targeted accountable justification<br>This arm will have the physician-targeted accountable justification implementation strategy | Behavioral: physician-targeted accountable justification<br>* 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.<br>|
| Active Comparator: Default order set + physician-targeted accountable justification<br>This arm will have the default order set and physician-targeted accountable justification | Behavioral: Default order set<br>* 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.<br>Behavioral: physician-targeted accountable justification<br>* 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.<br>|
| Placebo Comparator: Standard of Care<br>This arm will have no interventions and standard of care practices will be in place. | Other: Standard of Care<br>* ICUs and clinicians will deliver standard of care to patients with no intervention<br>|
| Active Comparator: Physician-targeted accountable justification + RT-targeted accountable justification<br>This arm will have the default order set and respiratory therapist-targeted accountable justification | Behavioral: RT-targeted accountable justification<br>* 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.<br>Behavioral: physician-targeted accountable justification<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 (hours) | first 72 hours of mechanical ventilation, during study intervention period | 
| sustainability | the percentage of time that a patient is exposed to tidal volume <6.5 cc/kg ideal body weight (IBW) among MV patients (hours) | first 72 hours of mechanical ventilation, during study observation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of exposure to tidal volume >8 cc/kg and >10 cc/kg IBW | Total duration of exposure to tidal volume >8 cc/kg and >10 cc/kg IBW (hours) | from initiation to discontinuation of mechanical ventilation, average of 72 hours | 
| hospital mortality | patient mortality occurring during hospitalization | from hospital admission to hospital discharge, average of 120 hours | 
| ICU length of stay | ICU length of stay (hours) | from time of first eligibility to ICU discharge, average of 120 hours | 
| hospital length of stay | hospital length of stay (hours) | from time of first eligibility to hospital discharge, average of 264 hours | 
| hospital discharge disposition | patient disposition at time of hospital discharge | through time of hospital discharge, average of 264 hours | 
| mechanical ventilation duration | mechanical ventilation duration (hours) | from initiation to discontinuation of mechanical ventilation, average of 72 hours | 
| initial tidal volume administered | initial tidal volume (cc/kg) | at time of mechanical ventilation initiation, average of 72 hours | 
| Duration of time exposed to plateau pressure (Pplat)>30 mmHg | Duration of time exposed to plateau pressure (Pplat)>30 mmHg (hours) | from initiation to discontinuation of mechanical ventilation, average of 72 hours | 
| total cumulative doses of sedative medications during and after mechanical ventilation | Total cumulative doses of sedative medications during and after mechanical ventilation | from initiation of mechanical ventilation to hospital discharge, average of 264 hours | 
| Total number of days with acute brain dysfunction during hospitalization | Total number of days with acute brain dysfunction during hospitalization, during and after mechanical ventilation | from initiation of mechanical ventilation to hospital discharge, average of 264 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, lung-protective ventilation