Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ARDS
- Sponsor
- University of Pennsylvania
- Enrollment
- 7342
- Locations
- 5
- Primary Endpoint
- Fidelity to LPV
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Fidelity to LPV
Time Frame: 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 Outcomes
- 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 >10 cc/kg PBW(from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days))
- Initial Tidal Volume Administered(within 24 hours of initiation of mechanical ventilation in a study ICU)
- Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)(within 24 hours of 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.)
- ICU-free Days(from time of first eligibility to 30 days)
- Hospital Free Days(from time of first eligibility to 30 days)
- Ventilator Free Days(from time of first eligiblity to 30 days)
- 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)
- Early Deep Sedation(up to 72 hours, from the initiation to the discontinuation of mechanical ventilation in the ICU)
- Average Sedation Intensity Within the First 72 Hours(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(up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICU)