- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06146348
Deimplementing CXR After CVC (DRAUP) in the ICU
Adapting and Testing a Deimplementation Program in the Intensive Care Unit
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63108
- Washington University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Measure the effectiveness and cost effectiveness of DRAUP on discontinuation of CXRs DRAUP training: ICU faculty, fellows, senior residents (post graduate year 3) and advanced practice practitioners
critically ill patients receiving a CVC
Description
-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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CVC confirmed by DRAUP
new mode of CVC confirmation for correct location and excluding pneumothorax
|
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.
|
|
Experimental: CVC confirmed by CXR
traditional mode of CVC confirmation for correct location and excluding pneumothorax
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DRAUP in
Time Frame: 24 months
|
Deadoption of CXR after US guided CVC confirmation
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fidelity
Time Frame: 24 months
|
Percentage of DRAUP non-adherence
|
24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Enyo Ablordeppey, MD MPH, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202312113
- 5K01HL161026-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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