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

Critical Illness Clinical Trial

— INPUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663802
• Other study ID #: 833400
• Secondary ID: 1R01HL141608-01A
• Status: Completed
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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 RT-targeted accountable justification strategy (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6941
• Est. completion date: December 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• ARDS
• Critical Illness
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Behavioral:
• RT-targeted accountable justification
This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
• 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 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
• physician-targeted accountable justification
When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, 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.

Other:
• Standard of Care
ICUs and clinicians will deliver standard of care to patients with no intervention

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Princeton Medical Center	Plainsboro	New Jersey
United States	Chester County Hospital	West Chester	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fidelity to LPV	percentage of time that a patient is exposed to tidal volume <6.5 cc/kg ideal body weight (hours)	first 72 hours of mechanical ventilation, during study intervention period
Primary	sustainability	the percentage of time that a patient is exposed to tidal volume <6.5 cc/kg ideal body weight (IBW) among MV patients (hours)	first 72 hours of mechanical ventilation, during study observation period
Secondary	Total duration of exposure to tidal volume >8 cc/kg and >10 cc/kg IBW	Total duration of exposure to tidal volume >8 cc/kg and >10 cc/kg IBW (hours)	from initiation to discontinuation of mechanical ventilation, average of 72 hours
Secondary	hospital mortality	patient mortality occurring during hospitalization	from hospital admission to hospital discharge, average of 120 hours
Secondary	ICU length of stay	ICU length of stay (hours)	from time of first eligibility to ICU discharge, average of 120 hours
Secondary	hospital length of stay	hospital length of stay (hours)	from time of first eligibility to hospital discharge, average of 264 hours
Secondary	hospital discharge disposition	patient disposition at time of hospital discharge	through time of hospital discharge, average of 264 hours
Secondary	mechanical ventilation duration	mechanical ventilation duration (hours)	from initiation to discontinuation of mechanical ventilation, average of 72 hours
Secondary	initial tidal volume administered	initial tidal volume (cc/kg)	at time of mechanical ventilation initiation, average of 72 hours
Secondary	Duration of time exposed to plateau pressure (Pplat)>30 mmHg	Duration of time exposed to plateau pressure (Pplat)>30 mmHg (hours)	from initiation to discontinuation of mechanical ventilation, average of 72 hours
Secondary	total cumulative doses of sedative medications during and after mechanical ventilation	Total cumulative doses of sedative medications during and after mechanical ventilation	from initiation of mechanical ventilation to hospital discharge, average of 264 hours
Secondary	Total number of days with acute brain dysfunction during hospitalization	Total number of days with acute brain dysfunction during hospitalization, during and after mechanical ventilation	from initiation of mechanical ventilation to hospital discharge, average of 264 hours