Implementation of the Intravitreal Injection Administered by Nurses

Официальное название

Implementation of the Intravitreal Injection Service Administered by Nurses: Safety and Satisfaction of the Patients Served

Обзор

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.

Вмешательства

• Процедура It is a implementation a program incorporating nurses trained in administering intravitreal injections within the functional unit of Ophthalmology following the usual technique
  Internationally, some experiences demonstrate that the administration of intravitreal injections, especially by nurses trained in aseptic techniques, is feasible without compromising patient safety. Although there is already some experience in Spain, it is a new procedure within the nursing field of the Ophthalmology service for which no results have been reported.

Первичные конечные точки

• Complications presented during the IIV technique [Срок оценки: In each injection during and after the procedure until the end of treatment]
• Late post-procedure complications [Срок оценки: In each injection during and after the procedure until the end of treatment]

Вторичные конечные точки (12)

• Sociodemographic variables [Срок оценки: At the beginning of treatment]
• Date of treatment indication [Срок оценки: At the beginning of treatment]
• Ocular Diagnosis [Срок оценки: At the beginning of treatment]
• Ocular comorbidity [Срок оценки: At the beginning of treatment]
• Previous experience [Срок оценки: At the beginning of treatment]
• Companion [Срок оценки: In each injection until the end of the treatment]
• Visit to the ophthalmologist between therapies [Срок оценки: In each injection until the end of the treatment]
• Anxiety level [Срок оценки: In each injection until the end of the treatment]
• Treated eye [Срок оценки: In each injection until the end of the treatment]
• Ophthalmologist visit during the session [Срок оценки: In each injection until the end of the treatment]
• IVI Medication [Срок оценки: In each injection until the end of the treatment]
• Patient Pain [Срок оценки: In each injection until the end of the treatment]

Критерии участия

Критерии включения

\- People over 18 years of age who require intravitreal therapy in the ophthalmology service

Критерии исключения

• Non-collaborators in the technique for physical, psychological or nystagmus reasons.
• Have recent evidence of blepharitis or conjunctivitis ≤15 days (ex, red eye or thick discharge) to avoid the risk of introducing infection into the eyeball.
• Suffer ischemic heart disease or recent stroke ≤3 months to avoid the risk of precipitating another vascular ischemic attack.
• With intravitreal steroid implant.
• Pregnant women: Due to the potential teratogenic effect of anti-FCEV

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Corporation Parc Tauli — Sabadell

Идентификаторы

NCT: NCT06511700 · Intravitrial-injection2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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