Clinical trial NCT04663802: Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study
Official title: Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Critical Illness
Acute Respiratory Distress Syndrome
Acute Respiratory Failure
Keywords: mechanical ventilation
lung-protective ventilation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-12-11
Enrollment: 7342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fidelity to LPV
timeFrame: up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilation
Secondary outcomes:
measure: Total Duration of Exposure to Tidal Volume >8 cc/kg PBW
timeFrame: from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)
measure: Total Duration of Exposure to Tidal Volume >10 cc/kg PBW
timeFrame: from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)
measure: Initial Tidal Volume Administered
timeFrame: within 24 hours of initiation of mechanical ventilation in a study ICU
measure: Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)
timeFrame: within 24 hours of initiation of mechanical ventilation in a study ICU
measure: Hospital Mortality
timeFrame: 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.
measure: ICU-free Days
timeFrame: from time of first eligibility to 30 days
measure: Hospital Free Days
timeFrame: from time of first eligibility to 30 days
measure: Ventilator Free Days
timeFrame: from time of first eligiblity to 30 days
measure: Hospital Discharge Disposition
timeFrame: At the time of discharge from the hospital, up to 720 hours (30 days) after initiation of mechanical ventilation in a study ICU
measure: Early Deep Sedation
timeFrame: up to 72 hours, from the initiation to the discontinuation of mechanical ventilation in the ICU
measure: Average Sedation Intensity Within the First 72 Hours
timeFrame: Up to 72 hours, from initiation to discontinuation of mechanical ventilation in a study ICU
measure: Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation
timeFrame: up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICU
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Princeton Medical Center
state: New Jersey
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: West Chester
country: United States
facility: Chester County Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Meeta Kerlin, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.