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

University of Pennsylvania

Status: Completed

Conditions: Critical Illness; Acute Respiratory Distress Syndrome; Acute Respiratory Failure; ARDS

Treatments: Behavioral: Physician-targeted accountable justification; Behavioral: Default order set; Behavioral: Respiratory therapist (RT)-targeted accountable justification

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04663802

833400

1R01HL141608-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,342 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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7,342 participants in 5 patient groups

Usual care

No Intervention group

Description:

This arm will have no interventions and standard of care practices will be in place.

Default order set

Active Comparator group

Description:

This arm will have the default order set implementation strategy

Treatment:

Behavioral: Default order set

Physician-targeted accountable justification

Active Comparator group

Description:

This arm will have the physician-targeted accountable justification implementation strategy

Treatment:

Behavioral: Physician-targeted accountable justification

Default order set + RT-targeted accountable justification

Active Comparator group

Description:

This arm will have the default order set and respiratory therapist-targeted accountable justification

Treatment:

Behavioral: Respiratory therapist (RT)-targeted accountable justification

Behavioral: Default order set

Physician-targeted accountable justification + RT-targeted accountable justification

Active Comparator group

Description:

This arm will have the default order set and respiratory therapist-targeted accountable justification

Treatment:

Behavioral: Respiratory therapist (RT)-targeted accountable justification

Behavioral: Physician-targeted accountable justification