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

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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

Tracking Information
First Submitted Date March 20, 2020
First Posted Date March 27, 2020
Last Update Posted Date April 12, 2022
Actual Study Start Date December 9, 2019
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2020)
  • 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
  • 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
  • Fidelity [ Time Frame: 1 year ]
    Fidelity will be measured by calculating the degree (%) to which the DRAUP algorithm was implemented as it was prescribed
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 25, 2020)
Effectiveness [ Time Frame: 1 year ]
Effectiveness will be measured by calculating the sensitivity/specificity of POCUS guided CVC confirmation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Implementation of Ultrasound Guided Central Venous Catheter Confirmation Protocol
Official Title De-Implementation Of Routine Chest Radiographs After Adoption of Ultrasound Guided Insertion and Confirmation of Central Venous Catheter Protocol
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Clinical healthcare workers involved in the placement and/or maintenance of central venous catheters (nurses, doctors, administrators)
Condition
  • Behavior
  • Process, Acceptance
  • Inertia of Accommodation
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Ablordeppey EA, Powell B, McKay V, Keating S, James A, Carpenter C, Kollef M, Griffey R. Protocol for DRAUP: a deimplementation programme to decrease routine chest radiographs after central venous catheter insertion. BMJ Open Qual. 2021 Oct;10(4). pii: e001222. doi: 10.1136/bmjoq-2020-001222.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 17, 2021)
120
Original Estimated Enrollment
 (submitted: March 25, 2020)
250
Estimated Study Completion Date April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Enyo Ablordeppey, MD 314-362-7021 ablordeppeye@wustl.edu
Contact: Richard Griffey, MD 314-747-4899 griffeyr@wustl.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04324762
Other Study ID Numbers 201807001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: 6 months (timeline for anticipated study protocol manuscript)
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Enyo A Ablordeppey, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date April 2022