Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study
Condition: ARDS; Critical Illness; Acute Respiratory Distress Syndrome; Acute Respiratory Failure
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury; Critical Illness
Study type: Interventional

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 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.
    

Intervention name(s): RT-targeted accountable justification; Default order set; physician-targeted accountable justification; Standard of Care
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): 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.; 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.; 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.; ICUs and clinicians will deliver standard of care to patients with no intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: mechanical ventilation; lung-protective ventilation