- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07449455
Assessing the Effect of Staff Education on Unused Peripheral Venous Catheter Rates in Emergency Departments. (ED-Cath 2)
Evaluation of the Impact of an Educational Intervention for Staff on the Rate of Peripheral Venous Catheters Inserted and Unused in Emergency Departments.
The placement of peripheral venous catheters (PVC) is a common procedure, estimated at 25 million per year in France according to SF2H in 2005. However, this procedure exposes patients to complications (hematoma, phlebitis, edema, sepsis, hemolysis of samples), is time-consuming, and costly. There is a significant proportion of PVCs placed unnecessarily, estimated between 23.7% and 60.7% according to studies. A study conducted at the Saint-Antoine Emergency Department showed that the best indicator of non-use of PVCs is the physician's prediction of non-utilization.
The investigators expect to achieve a significant reduction in unused PVCs after the intervention, thereby reducing adverse effects associated with PVC placement, freeing up paramedical time, and having a positive ecological and economic impact.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The placement of peripheral venous catheters (PVC) is a common practice in various hospital departments in France. It is estimated at 25 million per year in France according to the French Society for Hospital Hygiene (SFHH) in 2005.
According to Gledstone-Brown et al., the prescription of catheters "just in case" has been a longstanding practice in emergency departments (ED), initially motivated to improve patient safety. The recurring issue was the need for an emergency catheter placement once the patient was admitted to a hospital ward. Additionally, the hypothesis that an easily insertable catheter, performed concurrently with a blood draw, could facilitate future assessments or intravenous medication administration seemed appealing.
As a result, a significant proportion of catheters are unnecessarily placed, ranging from 23.7% to 60.7% according to studies. Limm et al. conducted a retrospective study in 2013 focusing on PVCs placed in an Australian ED. Emergency reports of all adult patients with a PVC were reviewed, excluding those with life-threatening emergencies or those with a pre-existing PVC upon arrival. A PVC was considered unused if it was not employed for fluid administration, medication, or contrast product. Out of 3829 patients admitted to the ED over 30 days, 570 (14.9%) received a PVC, of which 284 (49.8% [95% CI, 45.6-54.0%]) remained unused. Neurological or gynecological-obstetric consultation reasons were associated with non-utilization of PVC (OR 2.3 [95% CI, 0.69-3.8] and 2.1 [95% CI, 0.99-40.2], respectively), contrasting with gastrointestinal or respiratory difficulty consultations. A similar study by Craigie et al. in Canada in 2017 found that 48% of PVCs were unused, with orthopedic, cardiovascular, and hematology consultations being associated with non-utilization. Other studies, such as Salvetti et al.'s in Italy and Vandenbos et al.'s in Nice in 2000, reported percentages of unused PVCs at 60.7% and 33.8%, respectively.
Lewindon rightly emphasizes the need for more precise data on PVC placements in EDs to identify patients who do not require them. In 2018, Guilhard et al. conducted a prospective descriptive study focusing on PVC placements in the ED of the University Hospital of Saint-Denis in La Réunion, using a methodology similar to the aforementioned studies. Out of 605 included patients in the study month, 207 (34.2%) had a PVC placed, with 57% remaining unused. The study also highlighted intravenous prescriptions for medications with oral alternatives, including Paracetamol (51%), Ketoprofen (15%), Tramadol (13%), and Phloroglucinol (10%). Additionally, 142 out of 185 (77%) patients hospitalized from the ED had a PVC. However, Mailhe et al. showed in 2020 that 60.5% of them had their PVC removed within 24 hours of admission. This prospective study included 614 patients hospitalized from the ED to the infectious diseases department of the hospital-university institute of Marseille over six months. Results indicated that 509 (82.9%) arrived with a PVC, 260 (51.5%) were deemed unnecessary from the start, and 308 (60.5%) were removed within 24 hours. These findings align with those of Lederle et al. in 1992, who reported that, among 484 patients with a PVC, 168 (35% [95% CI, 31-39%]) had their catheter unused for at least 48 hours in a prospective study spanning six weeks in four hospital wards in the United States.
Catheter placement is time-consuming for nursing teams and uncomfortable for patients. Couteaux et al. demonstrated in 2008, through a one-day cross-sectional analysis in two hospitals of the Assistance Publique Hôpitaux de Paris (APHP), that vascular punctures (especially venous) were the leading cause of pain among hospitalized patients, with 38% of 671 painful events associated with this procedure. Catheter placement exposes patients to various adverse effects analyzed by Miliani et al. this multicenter prospective observational study (one surgical department and four medical departments in three hospitals in northern France) conducted between June 2013 and June 2014 analyzed the occurrence of adverse effects after PVC placement and up to 48 hours after removal. Among the 815 PVCs analyzed, 164 phlebitis (20.1% [95% CI, 17.4-23.0%]), including 34 manifest ones (grade ≥3 according to Maddox classification, 4.1% [95% CI, 2.9-5.8%]), 144 hematomas at the puncture site (17.7% [95% CI, 15.1-20.5%]), 107 fluid leaks (13.1% [95% CI, 10.9-15.6%]), 31 edemas (3.8% [95% CI, 2.6-5.4%]), and 3 suspicions of catheter-related sepsis (0.4% [95% CI, 0.1-1.1%]) were noted. Finally, a literature review showed that samples taken from a catheter are more often hemolyzed (3.3% to 77% according to studies) than those obtained directly by venous puncture (0% to 3.8%).
This observation led to a study at the Saint-Antoine Hospital ED (APHP) in 2022 aiming to analyze the rate of PVC utilization in emergencies and identify predictive factors for non-utilization. The study revealed that 23.7% of prescribed PVCs were not used, with non-utilization factors being the prescriber's expectation of usage (OR=6.35 [95% CI, 2.64-15.29], p<0.001) and the prescription motive "if needed" (OR=3.54 [95% CI, 1.37-9.17], p=0.009). These results suggest that a PVC should not be prescribed if the prescriber does not anticipate its use (whether convinced of its non-utilization or uncertain) or if it is prescribed on an "if needed" basis to avoid adverse effects associated with PVC prescription. The Saint-Antoine ED decided to implement these prescription rules, along with a staff training strategy, which will be evaluated as part of this project.
A reasoned prescription of PVCs in the ED, based on a prescription rule considering the anticipation of use and the prescription motive, would lead to a reduction in unused PVC prescriptions while maintaining patient safety. Our primary objective is to assess the impact of an educational intervention for medical and paramedical teams on the rate of PVCs placed and unused in the ED based on care data.
Staff training aims to enforce prescription recommendations in patient care and will involve multiple informational meetings with medical and paramedical teams, sending emails, and posting posters in various emergency care stations. The study will communicate the literature analysis conclusions regarding the relevance of PVC prescription in the ED, particularly the results of the 2022 ED-cath study in the department: PVC placement exposes patients to complications (hematoma, phlebitis, edema, sepsis, hemolysis of samples), is time-consuming, and costly; 23.7% to 60% of PVCs placed in the ED are not used, and non-utilization is associated with the prescriber's anticipation of non-utilization and the prescription motive "if needed." Furthermore, 24.1% of used PVCs are exclusively for first or second-tier analgesics that have an oral alternative. Therefore, physicians are advised not to prescribe PVCs if they do not expect them to be used and to maximize oral analgesics.
The secondary objectives include assessing the estimated number of PVCs not placed due to the intervention, the number of PVC placements and blood samples taken subsequently (in patients for whom a PVC is not initially placed), the number of blood samples taken by direct venipuncture during initial patient management, the rate of orally administered analgesics, and the rate of hemolyzed blood samples according to the sampling technique (PVC placement or direct venipuncture).
The investigator anticipate a significant reduction in unused PVCs after the intervention, aiming to reduce adverse effects related to PVC placement, free up paramedical time, and have a positive ecological and economic impact.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Paris, France, 75012
- Service d'Accueil des Urgences Hôpital Saint-Antoine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients ≥ 18 years old
- Prescription and placement of a PVC and/or blood sample collection without PVC placement during the emergency department stay
- Patient non-opposition to the use of care data, collected by the investigating physician after informing the patient
Exclusion Criteria:
- Patient information impossible (language barrier, neuro-cognitive impairment…)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Before intervention
|
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After intervention
|
The staff training aims to enforce prescription recommendations in patient care and will involve multiple informational meetings with medical and paramedical teams, sending emails, and posting posters in various emergency care stations. The conclusions of the literature analysis regarding the relevance of prescribing PVCs in the ED will be communicated, notably the results of the ED-cath study conducted in 2022 in the department: PVC placement exposes patients to complications (hematoma, phlebitis, edema, sepsis, hemolysis of samples), is time-consuming, and costly; it has been shown that 23.7% to 60% of PVCs placed in the ED are not used, and non-utilization of the PVC is associated with the prescriber's anticipation of non-utilization and the prescription motive "if needed." |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of non-utilization of prescribed and placed PVCs in the emergency department during the emergency stay, before and after an educational intervention
Time Frame: 2 months
|
A PVC is considered used if the patient has received intravenous therapy (medication, filling solution, or contrast agent) or if a new blood sample has been taken remotely from the catheter placement (while the patient is still being managed in the ED).
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2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The estimated number of PVCs not placed due to the intervention in the post-intervention phase (the delta between the number of PVCs placed in each phase, relative to the number of visits to the ED).
Time Frame: 2 months
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2 months
|
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The rate of PVC placements performed subsequently in patients for whom a PVC is not initially placed.
Time Frame: 2 months
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2 months
|
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The rate of blood samples taken subsequently in patients for whom a PVC is not initially placed.
Time Frame: 2 months
|
2 months
|
|
The rate of blood samples taken by direct venipuncture during the initial patient management.
Time Frame: 2 months
|
2 months
|
|
The rate of orally administered analgesics.
Time Frame: 2 months
|
2 months
|
|
The rate of hemolyzed blood samples based on the sampling technique (PVC placement or direct venipuncture).
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
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
- APHP240397
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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