Impact of Implementing the Modified A-DIVA Scale on Successful Access to a Venous Line on the First Attempt (DIVAPERF)

Peripheral venous access (PVA), although commonly used, can be a difficult procedure for patients with precarious venous capital. The difficulty of insertion can lead to multiple attempts, with the consequences of pain, anxiety, delayed management and worsening of the potentially already precarious venous capital. One study assessed the risk of failure according to a score based on venous status criteria. This study first established a link between venous status criteria and the risk of failure. The criteria defined as determinants were used to establish a venous status score. The data were then repeated by analyzing the success rate as a function of the scale score. A clear link between score and risk of failure was established. It seems worthwhile to evaluate the impact of implementing this scale prior to the placement of a peripheral venous line.

The hypothesis is that obtaining a score predictive of failure would modify the therapeutic attitude of the registered nurse. They would opt for techniques that would increase their chances of success. This in turn would lead to a reduction in unsuccessful attempts, which generate pain and anxiety for the patient. Preserving venous capital by increasing first-attempt success is both a health issue for the patient and a guarantee of quality of care.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease
• Intervention / Treatment: Procedure: Training in the A-DIVA scale and its failure prediction score

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judith PASSILDAS JAHANMOHAN, PhD; Phone Number: +33473278005; Email: judith.passildas@clermont.unicancer.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63011
    • Recruiting
    • Centre Jean Perrin
    • Contact: Judith PASSILDAS JAHANMOHAN, PhD
    • Principal Investigator: Lucie MADELAINE
  • Clermont-Ferrand, France, 63000
    • Not yet recruiting
    • Chu Gabriel Montpied
    • Contact: Virginie HAUTEMAYOU
    • Principal Investigator: Virginie HAUTEMAYOU
  • Lyon, France, 69004
    • Not yet recruiting
    • Hôpital de La Croix Rousse
    • Contact: Charline TAUREAU
    • Principal Investigator: Charline TAUREAU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female patient of legal age included in a care program requiring a VVP;
• Fluency in French
• Patient affiliated to a social security scheme;
• Written, signed and dated informed consent.

Exclusion Criteria:

• As the A-DIVA scale specifies a search for venous access to the upper limb, any patient without an upper limb or with a condition that contraindicates VVP placement in the upper limbs will be excluded;
• Patients treated as emergencies;
• Patients with a language barrier or known significant cognitive or psychiatric disorders;
• Patients under guardianship, curatorship, deprivation of liberty or legal protection;
• Pregnant or breast-feeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Nurses will place a peripheral venous line on these patients without having been trained in the venous status score predictive of failure.
Experimental: Experimental arm; Nurses will place a peripheral venous line on these patients after being trained in the venous status score predictive of failure.	Procedure: Training in the A-DIVA scale and its failure prediction score; Nurses are trained in the A-DIVA scale and its predictive failure score. This score enables them to adapt their approach to peripheral venous line insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of peripheral venous vein placement	Success rate of peripheral venous vein insertion on the first attempt in the 2 groups (group in which VVP insertion will be performed by nurses not trained in the A-DIVA score and group in which VVP insertion will be performed after score assessment by nurses trained in the A-DIVA score) expressed by the number of attempts equal to 1.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of attempts	Total number of attempts	1 year
Number of visualization techniques, alternative devices and/or third-party assistance used	Number of visualization techniques, alternative devices and/or third-party assistance used	1 year
Number of years' experience of nurses since obtaining diploma in nursing	Number of years' experience of nurses since obtaining diploma in nursing	1 year
Pain score: Numerical Pain Scale	The pain score is based on a numerical pain scale ranging from 0 to 10, with 0 representing no pain and 10 representing unbearable pain.	1 year
A-DIVA scale score	The A-DIVA score (Adult Difficult Intravenous Access Score) predicts the difficulty of infusing an adult. The score ranges from 0 to 5, with 0 being the lowest risk of difficulty, and 5 being the highest.	1 year

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Study Director: Lucie MADELAINE, Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2023-A01480-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No