ARDSINPUTNCT04663802

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

A study testing Default order set, Physician-targeted accountable justification and Respiratory therapist (RT)-targeted accountable justification in people with ARDS and Critical Illness, run by University of Pennsylvania at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: ARDS, Critical Illness, Acute Respiratory Distress Syndrome
What is being tested?: Default order set, Physician-targeted accountable justification and Respiratory therapist (RT)-targeted accountable justification
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7,342 participants
Where: 5 sitesUnited States
Study dates: 22 Feb 2021to 15 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

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

Other trials in United States

About this 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.

Read the 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.

Conditions: ARDS, Critical Illness, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
Being tested: Default order set, Physician-targeted accountable justification, Respiratory therapist (RT)-targeted accountable justification
Keywords: mechanical ventilation, lung-protective ventilation
Medical subject headings: Critical Illness, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Default order setBehavioural
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 justificationBehavioural
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 justificationBehavioural
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.

Study groups in NCT04663802
Study group	Role	What they receive
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 Receives: Behavioral: Default order set
Physician-targeted accountable justification	Active comparator	This arm will have the physician-targeted accountable justification implementation strategy Receives: 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 Receives: 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 Receives: Behavioral: Physician-targeted accountable justification; Behavioral: Respiratory therapist (RT)-targeted accountable justification

What is being measured

The primary outcome is the main question the study is designed to answer.

Fidelity to LPV
percentage of time that a patient is exposed to tidal volume <6.5 cc/kg ideal body weight
Measured: 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
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.
Measured: 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
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.
Measured: from initiation to discontinuation of mechanical ventilation in the study ICU, up to 720 hours (30 days)
Initial Tidal Volume Administered
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)
Measured: within 24 hours of initiation of mechanical ventilation in a study ICU
Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)
Binary variable for whether initial plateau pressure (Pplat) > 30 cm H2O (first documented value after initiation of mechanical ventilation in a study ICU)
Measured: within 24 hours of initiation of mechanical ventilation in a study ICU
Hospital Mortality
All-cause mortality occurring during hospitalization.
Measured: 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
days alive and not admitted to an ICU; composite of ICU length of stay and death
Measured: from time of first eligibility to 30 days
Hospital Free Days
days alive and not admitted to a hospital;composite of hospital length of stay and death
Measured: from time of first eligibility to 30 days
Ventilator Free Days
days alive and not on mechanical ventilation; composite of ventilator free days and death
Measured: from time of first eligiblity to 30 days
Hospital Discharge Disposition
Location to which the patient was discharged after the end of the hospital admission
Measured: 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
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.
Measured: up to 72 hours, from the initiation to the discontinuation of mechanical ventilation in the ICU
Average Sedation Intensity Within the First 72 Hours
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.
Measured: 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
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.
Measured: up to 72 hours, from initiation until discontinuation of mechanical ventilation in a study ICU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 202115 Dec 2023

First posted11 Dec 2020
Study start22 Feb 2021
Primary completion15 Jun 2023
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ARDSStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 7,342 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04663802
Sponsor's protocol ID: 833400
Other IDs: 1R01HL141608-01A1
Acronym: INPUT
Status last verified: Sep 2024
First submitted: 5 Jun 2020
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie published results will be made available to other researchers, after deidentification.

Publications

Kerlin MP, Harhay MO, Li F, Small DS, Lu Y, Wang W, Fuchs BD, Mikkelsen ME, Tran T, Belk A, Silvestri JA, Klaiman T, Scott S, Levy E, Sjoding MW, Kohn R, Roberts KJ, Beidas RS, Halpern SD. Nudging implementation of low tidal volume ventilation: a stepped wedge, cluster randomized trial. Implement Sci. 2026 May 7;21(1):40. doi: 10.1186/s13012-026-01500-8.
PubMed 42098760
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.
PubMed 34376233

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of Nudges to Promote Utilization of Low Tidal Volume Ventilation (INPUT) Study
ClinicalTrials.gov ID: NCT04663802
Acronym / sponsor ID: INPUT / 833400
Conditions: ARDS, Critical Illness, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
Keywords: mechanical ventilation, lung-protective ventilation
Study type: Interventional
Recruitment status: Completed
Enrolment: 7,342 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 22 Feb 2021 (actual)
Primary completion: 15 Jun 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 11 Dec 2020 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Usual care	No intervention	–This arm will have no interventions and standard of care practices will be in place.
Default order set	Active comparator	Behavioral: Default order setThis arm will have the default order set implementation strategy
Physician-targeted accountable justification	Active comparator	Behavioral: Physician-targeted accountable justificationThis arm will have the physician-targeted accountable justification implementation strategy
Default order set + RT-targeted accountable justification	Active comparator	Behavioral: Default order set, Behavioral: Respiratory therapist (RT)-targeted accountable justificationThis arm will have the default order set and respiratory therapist-targeted accountable justification
Physician-targeted accountable justification + RT-targeted accountable justification	Active comparator	Behavioral: Physician-targeted accountable justification, Behavioral: Respiratory therapist (RT)-targeted accountable justificationThis arm will have the default order set and respiratory therapist-targeted accountable justification

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Default order setWith 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.	Behavioural	Default order set, Default order set + RT-targeted accountable justification
Physician-targeted accountable justificationWhen 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.	Behavioural	Physician-targeted accountable justification, Physician-targeted accountable justification + RT-targeted accountable justification
Respiratory therapist (RT)-targeted accountable justificationIf 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.	Behavioural	Default order set + RT-targeted accountable justification, Physician-targeted accountable justification + RT-targeted accountable justification

Primary outcome

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

12 secondary outcomes

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 >10 cc/kg PBW
Time frame: 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
Initial Plateau Pressure (Pplat)>30 Centimeters of Water (cm H2O)
Time frame: 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.
ICU-free Days
Time frame: from time of first eligibility to 30 days
Hospital Free Days
Time frame: from time of first eligibility to 30 days
Ventilator Free Days
Time frame: 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
Early Deep Sedation
Time frame: 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
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

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Strategy A+C, Wedge 1 (ICU #1)	85	85
Strategy B+C, Wedge 1 (ICU #2)	91	91
Strategy A+C, Wedge 2 (ICU #3)	30	30
Strategy B+C, Wedge 2 (ICU #4)	28	28
Strategy A+C, Wedge 3 (ICU #5)	73	73
Strategy B+C, Wedge 3 (ICU #6)	53	53
Strategy A+C, Wedge 4 (ICU #7)	104	104
Strategy B+C, Wedge 4 (ICU #8)	66	66
Strategy A+C, Wedge 5 (ICU #9)	141	141
Strategy B+C, Wedge 5 (ICU #10)	55	55
Strategy A+C, Wedge 6 (ICU #11)	58	58
Strategy B+C, Wedge 6 (ICU #12)	40	40

Primary outcome: Fidelity to LPV

Time frame: up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilation. Median (Inter-Quartile Range). Unit: Percentage of time during first 72 hours

Measure	Standard of Care n = 2976	Default Order Set n = 956	Physician-targeted Accountable Justification n = 734	Default Order Set + RT-targeted Accountable Justification n = 1480	Physician-targeted Accountable Justification + RT-targeted Accountable Justification n = 1196
Value	43.3 (0 to 100)	19.1 (0 to 98.3)	83.9 (0.5 to 100)	31.0 (0 to 99.5)	67.8 (0 to 100)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events collected through 24 hours after study enrollment, which was defined as start of invasive mechanical ventilation in a study ICU. In addition, All-Cause Mortality was assessed through hospital discharge, up to 720 hours (i.e., 30 days), reported as outcome #6.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	95 of 2,976 (3.2%)	0 of 2,976 (0%)	844 of 2,976
Default Order Set	24 of 956 (2.5%)	0 of 956 (0%)	264 of 956
Physician-targeted Accountable Justification	39 of 734 (5.3%)	0 of 734 (0%)	231 of 734
Default Order Set + RT-targeted Accountable Justification	42 of 1,480 (2.8%)	0 of 1,480 (0%)	367 of 1,480
Physician-targeted Accountable Justification + RT-targeted Accountable Justification	64 of 1,196 (5.4%)	0 of 1,196 (0%)	394 of 1,196

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42098760Kerlin MP, Harhay MO, Li F, Small DS, Lu Y, Wang W, Fuchs BD, Mikkelsen ME, Tran T, Belk A, Silvestri JA, Klaiman T, Scott S, Levy E, Sjoding MW, Kohn R, Roberts KJ, Beidas RS, Halpern SD. Nudging implementation of low tidal volume ventilation: a stepped wedge, cluster randomized trial. Implement Sci. 2026 May 7;21(1):40. doi: 10.1186/s13012-026-01500-8.
Derived from this study: PubMed 34376233Kerlin 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.
Individual participant dataSharing planned: Yes. Individual participant data that underlie published results will be made available to other researchers, after deidentification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Meeta Kerlin, MD, MSCE principal investigator

University of Pennsylvania

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fidelity to LPV (time frame: up to 72 hours, from initiation of mechanical ventilation in a study ICU until discontinuation of mechanical ventilation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04663802, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.