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Pediatric Guideline Adherence and Outcomes- Argentina

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ClinicalTrials.gov Identifier: NCT03896789
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Children's National Health System
Centro de Informática e Investigación Clínica (CIIC)
Washington State University
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Monica Vavilala, University of Washington

Brief Summary:
Pediatric traumatic brain injury (TBI) is the leading killer of children worldwide but effective treatments for TBI are limited. Although evidenced-based pediatric TBI guidelines exist, adherence to these guidelines is low,leading us to develop a new Pediatric Guideline Adherence and Outcomes (PEGASUS) program to increase TBI guideline adherence. We propose to test the PEGASUS program's ability to improve TBI guideline adherence and outcomes.

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Other: PEGASUS Program for Care Not Applicable

Detailed Description:

Specific Aim 1: Determine the relationship between PEGASUS program implementation and TBI guideline adherence (Aim 1a), and assess system, provider, patient, implementation and guideline factors associated with TBI guideline adherence (Aim 1b). Hypothesis: Centers that receive the PEGASUS program have higher TBI guideline adherence (main outcome), as well as better discharge survival and 3-month Glasgow Outcome Scale-Extended (GOSE) score (secondary outcomes) than centers who receive usual care.

Specific Aim 2: Create a value stream map (VSM) to identify value-added processes of care associated with TBI guideline adherence. Hypothesis: ICU activity flows of TBI care during the first 72 hours will reveal value-added as well as non-value-added processes in severe TBI care. PEGASUS program implementation will result in more value-added TBI care processes and better TBI guideline adherence.

Specific Aim 3: Use computer simulation to develop and disseminate a real-world best practices blueprint for TBI guideline adherence. Hypothesis: This model will identify the impact of the PEGASUS program on KPIs, outcomes (Aim 1), and process activities (Aim 2). Iterative computer simulations will then demonstrate the relationship among PEGASUS program components and how relative changes in these components impact the magnitude, direction and choice of operations downstream in TBI care and patient outcomes to inform development of a blueprint for wide dissemination of best-practice guidelines.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Step 1
This arm will receive the PEGASUS program (intervention) starting at 21 months
Other: PEGASUS Program for Care
This Is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.

Experimental: Step 2
This arm will receive the PEGASUS program (intervention) starting at 33 months
Other: PEGASUS Program for Care
This Is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.

Experimental: Step 3
This arm will receive the PEGASUS program (intervention) starting at 45 months
Other: PEGASUS Program for Care
This Is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.




Primary Outcome Measures :
  1. TBI guideline adherence [ Time Frame: ICU Stay, approximately up to 2 weeks ]
    The main outcome will be measured as the sum of indicators to which care was adhered by the number of relevant adherence indicators for a given patient during ICU stay.


Secondary Outcome Measures :
  1. Clinical Pathway Adoption [ Time Frame: within 24 hours of patient admission ]
    This outcome will be measured as yes/no for each eligible patient at intervention centers.

  2. Discharge Survival [ Time Frame: At Hospital Discharge, approximately up to 5 weeks ]
    We will examine the number of survivors between intervention and control centers (descriptive and not powered for this outcome).

  3. GOSE-Peds. Pediatric Version of the Glasgow Outcome Scale-Extended [ Time Frame: 3 months post discharge ]

    We will examine participants' Pediatrics Glasgow Outcome Scale-Extended (GOSE-Peds).

    GOS-E PEDS Score:

    8-Death 7- Vegetative State (VS) 6- Lower Severe Disability (Lower SD) 5- Upper Severe Disability (Upper SD) 4- Lowe Moderate Disability (Lower MD) 3- Upper Moderate Disability (Upper MD) 2- Lower Good Recovery (Lower GR)

    1-Upper Good Recovery (Upper GR)

    -Higher scores represent an increasing level of disability.


  4. Mortality [ Time Frame: 3 months post discharge ]
    We will examine participants' mortality at 3 months post discharge

  5. DIBQ (Determinants of Implementation Behaviors Scale) [ Time Frame: Baseline, and quarterly during year 1 after randomization; then once annually through study completion, approximately 3 years, for intervention sites. ]
    This questionnaire measures de contructs found in the TDF (Theoretical Domain Framework). We will use the short version with 41 items.

  6. Value added processes assessed by Organizational Questionnaire for Participant Hospitals [ Time Frame: Baseline and annually through study completion, approximately 3 years ]
    We will ask participant sites to answer a Hospital, Unit and Medical Staff Information, Quality of Care, Medication and Culture of Safety questionnaire developed by Monica S. Vavilala, Bryan Weiner and Silvia Lujan for this study.

  7. Changes in patient outcomes from time in - to time out- of the sytem based on manipulations of KIPs [ Time Frame: during ICU care, approximately up to 2 weeks ]
    We will examine the behavior of TBI care processes. We will evaluate the effect of interventions on key guideline indicators, adherence to Guidelines, and GOSE-Peds (described in out come 4). Inputs from parameter estimates from the regression models (Aim 1) and inputs from VSMs (Aim 2) will be used to develop computer simulation models using commercially available discrete event modeling and simulation software (e.g., SIMIO®, Simio LLC, Sewickley, PA). Parameter estimates from the regression models will then be used to model the distribution of the 15 indicators from the Pediatric Guidelines that are already integrated in the process flow. This provides a way to observe changes in patient outcomes from time-in to time-out of the system based on manipulations of KPIs. Each KPI will be initially "weighted" based on the parameter estimates obtained from the regression models.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mechanism or head CT consistent with TBI
  • <18 years old
  • GCS score ≤8 at any point during hospital admission

Exclusion Criteria:

- none


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): NCT03896789


Contacts
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Contact: Julia Velonjara, MPH 2067449430 julialv@uw.edu

Sponsors and Collaborators
University of Washington
Children's National Health System
Centro de Informática e Investigación Clínica (CIIC)
Washington State University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Monica Vavilala, MD University of Washington

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Responsible Party: Monica Vavilala, Professor, School of Medicine: Anesthesiology and Pain Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03896789     History of Changes
Other Study ID Numbers: STUDY00005629
1R01NS106560-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with Co-Investigators
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Monthly as available

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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 Monica Vavilala, University of Washington:
guideline adherence
implementation fidelity
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System