Viewing Study NCT06511700



Ignite Creation Date: 2024-10-26 @ 3:35 PM
Last Modification Date: 2024-10-26 @ 3:35 PM
Study NCT ID: NCT06511700
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-03

Brief Title: Implementation of the Intravitreal Injection Administered by Nurses
Sponsor: None
Organization: None

Study Overview

Official Title: Implementation of the Intravitreal Injection Service Administered by Nurses Safety and Satisfaction of the Patients Served
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Introduction

Intravitreal injections involve medication administration into the eye to treat ocular diseases and protect vision Through an injection the medication is introduced into the vitreous cavity an area located at the back of the eye behind the lens The intravitreal injection IVI is a minimally invasive process administered at personalized regular intervals It is a common procedure in ophthalmology for patients who require it International experiences demonstrate that administering intravitreal injections especially by nurses trained in aseptic techniques is feasible without compromising patient safety The project presented is based on a new care model rooted in interdisciplinary collaboration in the IVI process operationalizing it as a functional unit This is a great opportunity to expand the scope of practice for nurses and to demonstrate as has been done in other countries that the same procedure currently performed by ophthalmologists can be carried out with equal safety

Objective

To evaluate the safety of implementing a program incorporating nurses trained in administering intravitreal injections within the functional unit of Ophthalmology at Corporation Parc Tauli

Method

Observational evaluation study of a care process within the functional Ophthalmology Unit consisting of protocol application for intravitreal injection by trained nurses Data will be collected from users receiving care from the intravitreal injection service administered by nurses under a consensual procedure within the unit Users meeting the inclusion criteria will be eligible Nurses will be trained internally at CCSPT by the ophthalmology team User participation will be voluntary Informed consent will be obtained Data collection during the process of care will include recording selected variables Data collection will be carried out between 2024 and 2025 The study will be conducted over 3 years

Application and Impact

The development of this project will allow for a safe more efficient redistribution of our resources The functional unit is based on a group of professionals who work and make decisions jointly The new distribution will enable ophthalmologists to expand their availability for more complex procedures In the future it is expected to increase the number of users who can benefit from the IVI service and to initiate advanced competencies in the role of the ophthalmology nurse
Detailed Description: None

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: