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

NCT04663802 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7342

Last updated 2024-10-08

Study results available
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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.

Conditions

  • ARDS
  • Critical Illness
  • Acute Respiratory Distress Syndrome
  • Acute Respiratory Failure

Interventions

BEHAVIORAL

Default order set

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 milliliters per kilogram of predicted body weight (cc/kg PBW; as determined by each patient's height and gender). The physician will have the option to opt out of any of the specified LPV settings and select other values.

BEHAVIORAL

Physician-targeted accountable justification

When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg PBW, 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.

BEHAVIORAL

Respiratory therapist (RT)-targeted accountable justification

If an RT enters a tidal volume in a flowsheet documentation field value greater than 6 cc/kg PBW, an alert will appear requiring them to enter a reason for entering 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 RT will not be able to save the documentation in the EHR until after a response is entered.

Sponsors & Collaborators

Principal Investigators

  • Meeta Kerlin, MD, MSCE · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2023-06-15
Completion
2023-12-15

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04663802 on ClinicalTrials.gov