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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 : Unknown
Verified February 2017 by Northwestern University.
Recruitment status was:  Not yet recruiting
First Posted : February 13, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: 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
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : October 2019


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 ]
  2. Difference in proportions of patients receiving LTVV between intervention and usual care groups during trial period [ Time Frame: 12 Months ]
  3. LTVV rate in individual ICUs [ Time Frame: 12 Months ]
  4. Difference in overall LTVV rate between pre-trial and trial periods [ Time Frame: 12 Months ]
  5. Percentage of time receiving LTVV [ Time Frame: 12 Months ]
  6. Time from ARDS onset to LTVV initiation [ Time Frame: 12 Months ]
  7. Percentage of ventilator settings adherent to LTVV [ Time Frame: 12 Months ]
  8. ARDS duration [ Time Frame: 12 Months ]
  9. Proportion of clinicians using LTVV [ Time Frame: 12 Months ]
  10. Plateau pressure [ Time Frame: 12 Months ]
  11. ICU and hospital length of stay [ Time Frame: 12 Months ]
  12. ICU, hospital, 30-, 60-, 90-, 180-day and one year mortality [ Time Frame: 12 Months ]
  13. Discharge status [ Time Frame: 12 Months ]
  14. Ventilator duration [ Time Frame: 12 Months ]
  15. Intervention delivered as intended [ Time Frame: 12 Months ]
  16. Subgroup analyses of primary and secondary endpoints based on ARDS severity [ Time Frame: 12 Months ]
  17. Subgroup analyses of primary and secondary endpoints based on FiO2 [ Time Frame: 12 months ]
  18. Subgroup analyses of primary and secondary endpoints based on plateau pressure [ Time Frame: 12 months ]


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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


Contacts
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Contact: Curtis H Weiss, MD, MS curtisweiss@northwestern.edu
Contact: Katrina Tulas, BS ktulas@northwestern.edu

Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Curtis H Weiss, MD, MS       curtisweiss@northwestern.edu   
Contact: Katrina Tulas, BS       ktulas@northwestern.edu   
Principal Investigator: Curtis H Weiss, MD, MS         
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: Northwestern University
ClinicalTrials.gov Identifier: NCT03051139     History of Changes
Other Study ID Numbers: STU00202855
K23HL118139 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 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