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Completed

NCT Number: NCT04663802

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princeton Medical Center, Plainsboro, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Default order set

Behavioral

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.

Physician-targeted accountable justification

Behavioral

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.

Respiratory therapist (RT)-targeted accountable justification

Behavioral

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.

Primary outcomes

  1. 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

  1. Total Duration of Exposure to Tidal Volume >8 cc/kg PBW

    Time frame: from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)

    Total duration of exposure to tidal volume greater than 8 cc/kg PBW, in hours. The time frame for follow-up is based on the total duration of IMV during the total follow-up period of 30 days. Note it is intentionally different from the time frame of the primary outcome variable, which focuses on the initial 72 hours, as the period most likely to be influenced by the study interventions.

  2. Total Duration of Exposure to Tidal Volume >10 cc/kg PBW

    Time frame: from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)

    Total duration of exposure to tidal volume greater than 10 cc/kg PBW, in hours. The time frame for follow-up is based on the total duration of IMV during the total follow-up period of 30 days. Note it is intentionally different from the time frame of the primary outcome variable, which focuses on the initial 72 hours, as the period most likely to be influenced by the study interventions.

  3. Initial Tidal Volume Administered

    Time frame: within 24 hours of initiation of mechanical ventilation in a study ICU

    Binary variable for whether initial tidal volume (first documented value after initiation of mechanical ventilation in a study ICU) is less than or equal to 6.5 milliliters per kilogram of predicted body weight (cc/kg PBW)

  4. Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)

    Time frame: within 24 hours of initiation of mechanical ventilation in a study ICU

    Binary variable for whether initial plateau pressure (Pplat) > 30 cm H2O (first documented value after initiation of mechanical ventilation in a study ICU)

  5. Hospital Mortality

    Time frame: 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.

    All-cause mortality occurring during hospitalization.

  6. ICU-free Days

    Time frame: from time of first eligibility to 30 days

    days alive and not admitted to an ICU; composite of ICU length of stay and death

  7. Hospital Free Days

    Time frame: from time of first eligibility to 30 days

    days alive and not admitted to a hospital;composite of hospital length of stay and death

  8. Ventilator Free Days

    Time frame: from time of first eligiblity to 30 days

    days alive and not on mechanical ventilation; composite of ventilator free days and death

  9. Hospital Discharge Disposition

    Time frame: At the time of discharge from the hospital, up to 720 hours (30 days) after initiation of mechanical ventilation in a study ICU

    Location to which the patient was discharged after the end of the hospital admission

  10. Early Deep Sedation

    Time frame: up to 72 hours, from the initiation to the discontinuation of mechanical ventilation in the ICU

    The percentage of time during the first 72 hours of mechanical ventilation that patients were alive, in the ICU, and with Richmond Agitation-Sedation Scale (RASS) of -3 to -5 . The RASS measures a patient's depth of sedation and ranges from -5 (comatose) to +4 (combative), with a normal level of 0 (defined as "alert and calm"). Negative values indicate a patient is sedated and positive values indicate some degree of agitation.

  11. Average Sedation Intensity Within the First 72 Hours

    Time frame: Up to 72 hours, from initiation to discontinuation of mechanical ventilation in a study ICU

    Average Richmond Agitation-Sedation Scale (RASS) value, weighted by duration of time at that value. The RASS measures a patient's depth of sedation and ranges from -5 (comatose) to +4 (combative), with a normal level of 0 (defined as "alert and calm"). Negative values indicate a patient is sedated and positive values indicate some degree of agitation.

  12. Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation

    Time frame: up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICU

    Binary variable for whether a patient had Richmond Agitation-Sedation Scale (RASS) score of -3 to -5 for the entirety of the first 72 hours of mechanical ventilation. The RASS measures a patient's depth of sedation and ranges from -5 (comatose) to +4 (combative), with a normal level of 0 (defined as "alert and calm"). Negative values indicate a patient is sedated and positive values indicate some degree of agitation.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: INPUT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2020
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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