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

September 11, 2024 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7342

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • Plainsboro, New Jersey, United States, 08536
        • Princeton Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
      • West Chester, Pennsylvania, United States, 19380
        • Chester County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Default order set
This arm will have the default order set implementation strategy
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.
Active Comparator: Physician-targeted accountable justification
This arm will have the physician-targeted accountable justification implementation strategy
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.
Active Comparator: Physician-targeted accountable justification + RT-targeted accountable justification
This arm will have the default order set and respiratory therapist-targeted accountable justification
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.
No Intervention: Usual care
This arm will have no interventions and standard of care practices will be in place.
Active Comparator: Default order set + RT-targeted accountable justification
This arm will have the default order set and respiratory therapist-targeted accountable justification
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: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)
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.
from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)
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)
within 24 hours of initiation of mechanical ventilation in a study ICU
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)
within 24 hours of initiation of mechanical ventilation in a study ICU
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.
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.
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
from time of first eligibility to 30 days
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
from time of first eligibility to 30 days
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
from time of first eligiblity to 30 days
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
At the time of discharge from the hospital, up to 720 hours (30 days) after initiation of mechanical ventilation in a study ICU
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.
up to 72 hours, from the initiation to the discontinuation of mechanical ventilation in the ICU
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.
Up to 72 hours, from initiation to discontinuation of mechanical ventilation in a study ICU
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.
up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meeta Kerlin, MD, MSCE, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 833400
  • 1R01HL141608-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie published results will be made available to other researchers, after deidentification.

IPD Sharing Time Frame

Data will be available beginning 9 months after publication and up to 36 months following publication. After 36 months the data will be available in our University's data warehouse but without support, except for deposited metadata.

IPD Sharing Access Criteria

Proposals for data use will be reviewed by Principal Investigator and independent review boards (such as Institutional Review Board and Data Safety and Monitoring Board). Approved data requestors will need to sign data use agreements to access and use data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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