Deimplementing CXR After CVC (DRAUP) in the ICU

Behavior and Behavior Mechanisms Clinical Trial

Official title:

Adapting and Testing a Deimplementation Program in the Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06146348
• Other study ID #: 202312113
• Secondary ID: 5K01HL161026-02
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Enyo Ablordeppey, MD MPH
• Phone: 314-362-7021
• Email: ablordeppeye[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study proposes adapting and testing an innovative, behavioral theory-driven deimplementation program called DRAUP in two intensive care units for proof of concept and support that the program can help providers and hospital organizations address context determinants of deimplementation. Study data will be used to optimize the intervention for a subsequent larger trials.

Description:

There are millions of critically ill patients annually who require imaging confirmation after central venous catheter insertion. Emerging literature demonstrates that ultrasound is a faster alternative to historical chest xray, thus serving as the ideal confirmation for catheter use. When able to confirm catheter position, ultrasound decreases the number of unnecessary chest radiographs, cumulative resources (technologist, radiologist, equipment), and patient care delays. However, providers are not adopting this practice. Previously, we developed and initiated a successful evidence-based deimplementation program for ultrasound in lieu of chest xray called DRAUP in the Emergency Department. We now move to adapt the deimplementation bundle in the new environment of the Intensive Care Unit (ICU) with hopeful continued success. In experiment 1, qualitative analysis will be employ a systematic approach to DRAUP component refinement dosed to the unique context of the Intensive Care Unit and implementation outcomes as well as cost will be evaluated. In experiment 3, mixed methods will be used to evaluate the mechanism of impact of the refined program in the new environment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

-Measure the effectiveness and cost effectiveness of DRAUP on discontinuation of CXRs Inclusion Criteria for DRAUP training: (1) ICU faculty, fellows, senior residents (post graduate year 3) and advanced practice practitioners

• ICU inclusion for DRAUP program:
• Availability of ultrasound machines with archiving capability (DICOM)
• A minimum of 100 supradiaphragmatic CVC insertions annually in adult patients (age >18)
• Capacity to access digital archiving (PICOM)
• Patient inclusion for DRAUP program:
• supradiaphragmatic CVC placed
• Patient exclusion for DRAUP program:
• severe instability (cardiac arrest, severe shock) where CVC would be used without CXR,
• level 1 trauma;
• burn patients with no viable skin surface for imaging

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms
• Implementation Science

Intervention

Behavioral:
• adapted DRAUP strategy bundle
DRAUP deimplementation strategy bundle includes: 1) education and training, 2) supervision and in-person decision support, and 3) audit and feedback to target capability. Opportunity is addressed by 4) algorithm development and 5) organizational support. Finally, 6) facilitators and 7) planned adaptation after interval program assessment address the motivations needed to change behavior.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DRAUP in	Deadoption of CXR after US guided CVC confirmation	24 months
Secondary	Fidelity	Percentage of DRAUP non-adherence	24 months