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

NCT04663802 | Completed Results DMC

• 2 other identifiers: 8334001R01HL141608-01A1
• Study Type: interventional
• Target: 7,342
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

mechanical ventilation; lung-protective ventilation

Outcome Measures

Primary Outcomes (1)

• Fidelity to LPV

  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 Outcomes (12)

• 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 >10 cc/kg PBW

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

• Initial Tidal Volume Administered

  within 24 hours of initiation of mechanical ventilation in a study ICU

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

  within 24 hours of 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.

Study Arms (5)

Usual care

NO INTERVENTION

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

Default order set

ACTIVE COMPARATOR

This arm will have the default order set implementation strategy

Behavioral: Default order set

Physician-targeted accountable justification

ACTIVE COMPARATOR

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

Behavioral: Physician-targeted accountable justification

Default order set + RT-targeted accountable justification

ACTIVE COMPARATOR

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

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

Physician-targeted accountable justification + RT-targeted accountable justification

ACTIVE COMPARATOR

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

Behavioral: Physician-targeted accountable justification; Behavioral: Respiratory therapist (RT)-targeted accountable justification

Interventions

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.

Default order set; Default order set + RT-targeted accountable justification

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.

Physician-targeted accountable justification; Physician-targeted accountable justification + RT-targeted accountable justification

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.

Default order set + RT-targeted accountable justification; Physician-targeted accountable justification + RT-targeted accountable justification

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

Princeton Medical Center

Plainsboro, New Jersey, 08536, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Chester County Hospital

West Chester, Pennsylvania, 19380, United States

Location

Related Publications (1)

• Kerlin MP, Small D, Fuchs BD, Mikkelsen ME, Wang W, Tran T, Scott S, Belk A, Silvestri JA, Klaiman T, Halpern SD, Beidas RS. Implementing nudges to promote utilization of low tidal volume ventilation (INPUT): a stepped-wedge, hybrid type III trial of strategies to improve evidence-based mechanical ventilation management. Implement Sci. 2021 Aug 10;16(1):78. doi: 10.1186/s13012-021-01147-7.

  PMID: 34376233 DERIVED

MeSH Terms

Conditions

Critical Illness; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Dr. Meeta Prasad Kerlin (PI)
• Organization: University of Pennsylvania

prasadm@pennmedicine.upenn.edu

215-746-0446

Study Officials

• Meeta Kerlin, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: December 11, 2020
• Study Start: February 22, 2021
• Primary Completion: June 15, 2023
• Study Completion: December 15, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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

Locations

US (5)