Intravitreal Injections by Nurses and Physicians Compared

NCT ID: NCT02359149

Last Updated: 2019-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

Brief Summary

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Anti-VEGF agents are given for a variety of previously untreatable eye diseases. The last years indications for their use and consequently the number of patients needing treatment, have been increasing. Most patients require multiple injections. This has resulted in many eye departments administering thousands of injections per year, also at St Olavs University Hospital Trondheim. To cope with this increase in workload, it would be helpful if injections would be given not only by the physicians but also by the nurses. This study's objective is to compare efficiency, patient satisfaction and cost per patient of injections given by nurses and physicians.

Detailed Description

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Conditions

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Eye Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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nurse

intravitreal injections with anti-VEGF agents given by a nurse

Group Type EXPERIMENTAL

intravitreal injections given by a nurse

Intervention Type PROCEDURE

Intravitreal injections

Intervention Type PROCEDURE

Anti-VEGF agents

Intervention Type DRUG

physician

intravitreal injections with anti-VEGF agents given by a physician

Group Type ACTIVE_COMPARATOR

intravitreal injections given by a physician

Intervention Type PROCEDURE

Intravitreal injections

Intervention Type PROCEDURE

Anti-VEGF agents

Intervention Type DRUG

Interventions

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intravitreal injections given by a nurse

Intervention Type PROCEDURE

intravitreal injections given by a physician

Intervention Type PROCEDURE

Intravitreal injections

Intervention Type PROCEDURE

Anti-VEGF agents

Intervention Type DRUG

Other Intervention Names

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anti vasculer endothelial growth factor

Eligibility Criteria

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Inclusion Criteria

* referred to the eye clinic for treatment of age related macular degeneration, diabetes retinopathy or retinal vein occlusion with anti-vascular endothelium growth factor
* Ability to provide written informed consent
* ability to comply with study assessments for the full duration of the study

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marit Fagerli, md

Role: STUDY_DIRECTOR

St. Olavs University Hospital

Locations

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St Olavs Hospital, Department of Ophthalmology

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Austeng D, Morken TS, Bolme S, Follestad T, Halsteinli V. Nurse-administered intravitreal injections of anti-VEGF: study protocol for noninferiority randomized controlled trial of safety, cost and patient satisfaction. BMC Ophthalmol. 2016 Oct 1;16(1):169. doi: 10.1186/s12886-016-0348-4.

Reference Type BACKGROUND
PMID: 27716253 (View on PubMed)

Bolme S, Morken TS, Follestad T, Sorensen TL, Austeng D. Task shifting of intraocular injections from physicians to nurses: a randomized single-masked noninferiority study. Acta Ophthalmol. 2020 Mar;98(2):139-144. doi: 10.1111/aos.14184. Epub 2019 Jul 3.

Reference Type RESULT
PMID: 31267688 (View on PubMed)

Bolme S, Austeng D, Morken TS, Follestad T, Halsteinli V. Cost consequences of task-shifting intravitreal injections from physicians to nurses in a tertiary hospital in Norway. BMC Health Serv Res. 2023 Mar 8;23(1):229. doi: 10.1186/s12913-023-09186-0.

Reference Type DERIVED
PMID: 36890535 (View on PubMed)

Other Identifiers

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2014/1719

Identifier Type: -

Identifier Source: org_study_id

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