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

Not Applicable

Completed

• Conditions: Critical Illness; Acute Respiratory Distress Syndrome; Acute Respiratory Failure; ARDS
• Interventions: Behavioral: Default order set; Behavioral: Physician-targeted accountable justification; Behavioral: Respiratory therapist (RT)-targeted accountable justification

• Registration Number: NCT04663802
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-11
• Study Start: 2021-02-22
• Primary Completion: 2023-06-15
• Study Completion: 2023-12-15
• Results First Submitted: 2024-06-21
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Results First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7342

Inclusion Criteria

1. Aged 18 and over; AND
2. Admission to 1 of the 12 participating ICUs; AND
3. Undergoing mechanical ventilation

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Default order set	Default order set	This arm will have the default order set implementation strategy
Physician-targeted accountable justification	Physician-targeted accountable justification	This arm will have the physician-targeted accountable justification implementation strategy
Default order set + RT-targeted accountable justification	Default order set	This arm will have the default order set and respiratory therapist-targeted accountable justification
Default order set + RT-targeted accountable justification	Respiratory therapist (RT)-targeted accountable justification	This arm will have the default order set and respiratory therapist-targeted accountable justification
Physician-targeted accountable justification + RT-targeted accountable justification	Physician-targeted accountable justification	This arm will have the default order set and respiratory therapist-targeted accountable justification
Physician-targeted accountable justification + RT-targeted accountable justification	Respiratory therapist (RT)-targeted accountable justification	This arm will have the default order set and respiratory therapist-targeted accountable justification

Primary Outcome Measures

Name	Time	Method
Fidelity to LPV	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 Outcome Measures

Name	Time	Method
Total Duration of Exposure to Tidal Volume >8 cc/kg PBW	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.
Total Duration of Exposure to Tidal Volume >10 cc/kg PBW	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.
Initial Tidal Volume Administered	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)
Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)	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)
Hospital Mortality	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.
ICU-free Days	from time of first eligibility to 30 days	days alive and not admitted to an ICU; composite of ICU length of stay and death
Hospital Free Days	from time of first eligibility to 30 days	days alive and not admitted to a hospital;composite of hospital length of stay and death
Ventilator Free Days	from time of first eligiblity to 30 days	days alive and not on mechanical ventilation; composite of ventilator free days and death
Hospital Discharge Disposition	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
Early Deep Sedation	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.
Average Sedation Intensity Within the First 72 Hours	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.
Deep Sedation for the Entirety of the First 72 Hours of Mechanical Ventilation	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.

Trial Locations

Locations (5)

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Princeton Medical Center; 🇺🇸 Plainsboro, New Jersey, United States

Chester County Hospital; 🇺🇸 West Chester, Pennsylvania, United States