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Implementation of Ultrasound Guided Central Venous Catheter Confirmation Protocol (DRAUP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324762
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
The bedside use of ultrasound after central venous catheter (CVCs) insertion has lagged behind other applications in medicine, thus presenting an opportunity for innovative, evidence-based research that will influence clinician behavior. This research focuses on bedside ultrasound applications as an example, to evaluate clinical practice change. Chest radiographs are associated with delays in initiating time-critical interventions and present an unexamined opportunity for improving patient care by evaluating the use of ultrasound in lieu of chest radiographs after CVC insertion. Strategic interventions for implementation are needed to hasten the adoption of this clinical innovation (ultrasound guided CVC confirmation protocol) allowing them to de-implement chest xrays when no longer indicated.

Condition or disease Intervention/treatment
Behavior Process, Acceptance Inertia of Accommodation Behavioral: targetted implementation strategies

Detailed Description:

The placement of central venous catheters (CVCs) is a common procedure performed in critically ill patients, with millions placed annually. The routine use of chest radiographs for CVC confirmation is outdated. Chest radiographs are associated with delays in initiating time-critical interventions and present an unexamined opportunity for improving resource utilization and associated costs. Radiography has been used for over 50 years for this purpose in the absence of other options. Emerging evidence suggests that a post-procedure chest radiographs are unnecessary when ultrasound is used to confirm catheter position and exclude pneumothorax (PCEP). Yet few in the medical community are likely aware of these data and even among those who are aware, chest radiographs continues to be the routine modality used for CVC PCEP.

The average 17 years it takes to translate clinical research into practice is too long and presents an opportunity to expedite implementation of innovations in critical care medicine. For the proposed project, "De-Implementation Of Routine Chest Radiographs After Adoption of Ultrasound Guided Insertion and Confirmation of Central Venous Catheter Protocol (DRAUP)", the hypothesis is that identifying determinants of behavior for intervention development (Aim 1) will increase the likelihood of developing successful strategies that will yield faster clinical adoption. Understanding the behavioral adaptations that have to occur is key to developing strategies that increase the uptake of evidence into healthcare practice and improving health outcomes. These strategies (targeting adoption and substitution) will then be implemented in a local Emergency Department (Aim 2) to determine if these selected implementation strategies will increase provider adoption, fidelity, and organizational penetrance (Aim 3) of ultrasound-guided CVC PCEP. A good clinical outcome would be a decrease in provider dependence on chest radiographs after ultrasound-guided CVC PCEP.

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: De-Implementation Of Routine Chest Radiographs After Adoption of Ultrasound Guided Insertion and Confirmation of Central Venous Catheter Protocol
Actual Study Start Date : December 9, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022
Groups and Cohorts
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Intervention Details:
  • Behavioral: targetted implementation strategies
    strategies at the individual and institutional level to promote implementation of an evidenced based innovation and de-implementation of an unnecessary, low value diagnostic test.

Outcome Measures
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Primary Outcome Measures :
  1. Adoption [ Time Frame: 1 year ]
    Adoption will be measured by calculating the absolute number and proportion who utilize POCUS guided protocol and deimplement chest radiographs after central venous catheter placement

  2. De-adoption [ Time Frame: 1 year ]
    De-adoption will be measured by calculating the absolute number and proportion who do not obtain chest radiographs after central venous catheter placement

  3. Fidelity [ Time Frame: 1 year ]
    Fidelity will be measured by calculating the degree (%) to which the DRAUP algorithm was implemented as it was prescribed


Secondary Outcome Measures :
  1. Effectiveness [ Time Frame: 1 year ]
    Effectiveness will be measured by calculating the sensitivity/specificity of POCUS guided CVC confirmation


Eligibility Criteria
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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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Clinical healthcare workers involved in the placement and/or maintenance of central venous catheters (nurses, doctors, administrators)
Criteria

Inclusion Criteria:

  • have a clinical role in the placement and maintenance of central venous catheters

Exclusion Criteria:

-

Contacts and Locations
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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): NCT04324762


Contacts
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Contact: Enyo Ablordeppey, MD 314-362-7021 ablordeppeye@wustl.edu
Contact: Richard Griffey, MD 314-747-4899 griffeyr@wustl.edu

Locations
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United States, Missouri
Washington Unversity School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Enyo Ablordeppey, MD    313-362-7021    ablordeppeye@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Enyo A Ablordeppey, MD Washington University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04324762    
Other Study ID Numbers: 201807001
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared via manuscript publication; specific IPDs can be requested by email. All shared data will be in the form of group assessments as to not identify an individual response or behavior pattern.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 6 months (timeline for anticipated study protocol manuscript)

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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 Washington University School of Medicine:
ultrasound
central venous catheter
POCUS
 chest radiography
Dissemination & Implementation
De-Implementation