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

December 1, 2023 updated by: Washington University School of Medicine

De-Implementation Of Routine Chest Radiographs After Adoption of Ultrasound Guided Insertion and Confirmation of Central Venous Catheter Protocol

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.

Study Overview

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 The routine use of chest radiographs for CVC confirmation is outdated.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 Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington Unversity School Of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
Fidelity
Time Frame: 1 year
Fidelity will be measured by calculating the degree (%) to which the DRAUP algorithm was implemented as it was prescribed
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 1 year
Effectiveness will be measured by calculating the sensitivity/specificity of POCUS guided CVC confirmation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Enyo A Ablordeppey, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2019

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

6 months (timeline for anticipated study protocol manuscript)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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