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

• ClinicalTrials.gov Identifier: NCT04324762
• Recruitment Status: Recruiting
• First Posted: March 27, 2020
• Last Update Posted: April 12, 2022
• Sponsor: Washington University School of Medicine
• 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

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.

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

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)

• Current Responsible Party: Washington University School of Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Washington University School of Medicine
• Original Study Sponsor: Same as current
• 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