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A Strategy to Improve Implementation of LTVV for Patients w/ ARDS

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ClinicalTrials.gov Identifier: NCT03051139
Recruitment Status : Withdrawn (PI left institution)
First Posted : February 13, 2017
Last Update Posted : March 6, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Curtis Weiss, Northwestern University

Brief Summary:
The primary objective of this study is to evaluate whether a multi-component implementation strategy/quality improvement intervention comprised of 1) clinical decision support that couples a natural language processing (NLP) acute respiratory distress syndrome (ARDS) recognition tool with a clinician alert system, and 2) audit and feedback improves the implementation of low tidal volume ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS). This will be accomplished with a cluster randomized controlled trial comparing the implementation strategy to usual care

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Behavioral: Multi-component LTVV implementation strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Cluster Randomized Controlled Trial of a Multi-component Strategy to Improve Implementation of Low Tidal Volume Ventilation for Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date : June 24, 2013
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017


Arm Intervention/treatment
Experimental: ICU A and ICU B
This is the intervention group.
Behavioral: Multi-component LTVV implementation strategy
Multicomponent LTVV implementation strategy consisting of: 1) physician orientation, 2) physician audit and feedback, and 3) clinical decision support comprised of a) an ARDS screening tool using a natural language processing (NLP) algorithm, b) EHR-based tasks for clinicians to complete, and c) a clinician reminder system.

No Intervention: ICU C and ICU D
This is the usual care group.



Primary Outcome Measures :
  1. LTVV rate [ Time Frame: 12 months ]
    The primary endpoint is the difference between intervention ICUs (ICUs A and B) and usual care ICUs (ICUs C and D) in the change in the LTVV rate between the pre-trial period and the trial period. The statistical analysis of the primary endpoint will be to test the null hypothesis that there is no difference in the change in the LTVV rate between intervention and usual care groups. LTVV is defined as a patient who receives any single tidal volume less than 6.5mL/kg predicted body weight between ARDS onset and the earlier or extubation, death, or ICU discharge. ARDS onset is defined as the time at which the latter of the following two events occurred: PaO2/FIO2 <= 300 and bilateral infiltrates reported on a chest imaging radiology report, which themselves must occur within 24 hours of each other.


Secondary Outcome Measures :
  1. Difference in proportions of patients receiving LTVV between intervention and usual care groups during pre-trial period [ Time Frame: 12 months ]
    Difference in proportions of patients receiving LTVV between intervention and usual care groups during pre-trial period

  2. Difference in proportions of patients receiving LTVV between intervention and usual care groups during trial period [ Time Frame: 12 Months ]
    Difference in proportions of patients receiving LTVV between intervention and usual care groups during trial period

  3. LTVV rate in individual ICUs [ Time Frame: 12 Months ]
    LTVV rate in individual ICUs

  4. Difference in overall LTVV rate between pre-trial and trial periods [ Time Frame: 12 Months ]
    Difference in overall LTVV rate between pre-trial and trial periods

  5. Percentage of time receiving LTVV [ Time Frame: 12 Months ]
    Percentage of time receiving LTVV

  6. Time from ARDS onset to LTVV initiation [ Time Frame: 12 Months ]
    Time from ARDS onset to LTVV initiation

  7. Percentage of ventilator settings adherent to LTVV [ Time Frame: 12 Months ]
    Percentage of ventilator settings adherent to LTVV

  8. ARDS duration [ Time Frame: 12 Months ]
    ARDS duration

  9. Proportion of clinicians using LTVV [ Time Frame: 12 Months ]
    Proportion of clinicians using LTVV

  10. Plateau pressure [ Time Frame: 12 Months ]
    Plateau pressure

  11. ICU and hospital length of stay [ Time Frame: 12 Months ]
    ICU and hospital length of stay

  12. ICU, hospital, 30-, 60-, 90-, 180-day and one year mortality [ Time Frame: 12 Months ]
    ICU, hospital, 30-, 60-, 90-, 180-day and one year mortality

  13. Discharge status [ Time Frame: 12 Months ]
    Discharge status

  14. Ventilator duration [ Time Frame: 12 Months ]
    Ventilator duration

  15. Intervention delivered as intended [ Time Frame: 12 Months ]
    Intervention delivered as intended

  16. Subgroup analyses of primary and secondary endpoints based on ARDS severity [ Time Frame: 12 Months ]
    Subgroup analyses of primary and secondary endpoints based on ARDS severity

  17. Subgroup analyses of primary and secondary endpoints based on FiO2 [ Time Frame: 12 months ]
    Subgroup analyses of primary and secondary endpoints based on FiO2

  18. Subgroup analyses of primary and secondary endpoints based on plateau pressure [ Time Frame: 12 months ]
    Subgroup analyses of primary and secondary endpoints based on plateau pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Clinician Inclusion Criteria:

  • All critical care attending physicians and critical care fellows who provide patient care on one of the participating ICU physician services at Northwestern Memorial Hospital (medical ICU [MICU], surgical critical care [SCC], anesthesia/critical care [ACC], neurocritical care [NCC]) during the study period
  • All resident physicians who provide patient care on the participating ICU services during the study period
  • All nurses who provide patient care in the participating ICUs during the study period
  • All respiratory therapists (RTs) who provide patient care in the participating ICUs during the study period

Patient Inclusion Criteria:

  • All patients admitted to a participating ICU service listed above during the study period and meeting the following additional criteria:
  • Age 18 or older
  • Receiving mechanical ventilation via endotracheal tube or tracheostomy
  • For primary analysis: meeting Berlin Definition of ARDS (as adjudicated by NLP algorithm)(2)
  • For non-ARDS comparator group: all patients meeting other inclusion criteria and not adjudicated as having ARDS
  • For pre-trial period: all patients age 18 or older and receiving mechanical ventilation

Exclusion Criteria:

- Patients whose time from ARDS onset to the earlier of extubation, death, or ICU discharge is less than 24 hours. ARDS onset is defined as the time at which the latter of the following two events occurred: PaO2/FIO2 <= 300 and bilateral infiltrates reported on a chest imaging radiology report (these must be within 24 hours of each other).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051139


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Curtis H Weiss, MD, MS Northwestern Univeristy
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Responsible Party: Curtis Weiss, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03051139    
Other Study ID Numbers: STU00202855
K23HL118139 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Curtis Weiss, Northwestern University:
Implementation Science
Low Tidal Volume Ventilation (LTVV)
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury