Purpose To test if task shifting of intraocular injections to nurses in a real‐world setting can result in similar visual function outcome with equal safety profile. Method All patients with either age‐related macular degeneration, retinal vein occlusion or diabetic macular oedema remitted to intraocular injections at a tertiary ophthalmology department in Norway between March 2015 and May 2017, were asked to participate. The participants were randomized to either nurse‐ or physician‐administered intraocular injections of anti‐vascular endothelial growth factor. The primary outcome measure was change in best‐corrected visual acuity from baseline to 1‐year follow‐up. The mean difference in the primary outcome between the groups was analysed by a noninferiority test with a margin of three letters in disfavour of the nurse group. Adverse events were recorded. Results Three hundred and forty‐two patients entered the study. Two hundred and fifty‐nine completed the 1‐year follow‐up and were included in the study sample for the analysis of the primary outcome. Nurse‐administered intraocular injections were noninferior to physician‐administered injections with 0.7 and 1.6 letters gained, respectively (95% CI of the mean difference, −2.9 to 1.0; p = 0.019, one‐sided t‐test). Two thousand and seventy‐seven injections and three ocular adverse events were recorded. Conclusion Task shifting of intraocular injections to nurses can be performed without increased risk to visual function. Such a task shift can alleviate the burden of performing intraocular injections in ophthalmology departments. To our knowledge, this is the first RCT on task shifting of a surgical procedure from physicians to nurses in a high‐income country.
BackgroundIntravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) now improve or stabilize visual acuity in a number of previously untreatable eye diseases, of which the main are age-related macular degeneration, retinal vein occlusion and diabetic macular edema. Most patients require multiple injections over lengthy periods of time and the prevalence of treatable conditions is increasing. Anti-VEGF IVI normally administered by physicians, therefore represent a considerable workload on ophthalmologic clinics and will continue to do so in the near future. Nurse-administered IVI may relieve this workload, but the safety, cost and patient satisfaction of such an extended role for nurses in ophthalmologic clinics has not earlier been investigated. To investigate these outcomes following independent anti-VEGF IVI by trained nurses, a noninferiority randomized controlled trial is being conducted.Methods/DesignPatients eligible for anti-VEGF treatment, minimum 304, are recruited and randomized to IVI administration by either trained nurses or physicians. The primary outcome is safety, measured by difference in mean change in visual acuity between the two groups during an observation period of 12 months. Secondary outcomes are incidence of ocular adverse events, cost per patient and patient satisfaction.DiscussionThis study protocol describes the design of the first randomized controlled trial of nurse-administered IVI of anti-VEGF. The study is designed to examine safety, cost and patient satisfaction during 12 months follow-up.Trial registrationClinicalTrials.gov NCT02359149. Registered February 4, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12886-016-0348-4) contains supplementary material, which is available to authorized users.
Background Intravitreal injections of anti-vascular endothelial growth factor are high-volume procedures and represent a considerable workload on ophthalmology departments. Several departments have tried to meet this increase by shifting the task to nurses. To maintain high-quality patient care, we developed a training program for nurses that certifies them to administer injections. This qualitative study aimed to evaluate whether the nurses were confident and in control after participating in the training program and whether they were satisfied with the training and the new task. Methods Between 2014 and 2018, 12 registered nurses were trained in a tertiary hospital in central Norway. All the nurses were interviewed, either individually (n = 7) or in a group (n = 5). We analysed the interviews using Graneheim and Lundman’s qualitative content analysis. Results Eight subthemes were clustered within four main themes: 1) procedure and challenges, 2) motivation, 3) cooperation and confidence, and 4) evaluation. The nurses felt confident and in control when administering injections but experienced moments of insecurity. The new task gave the nurses a sense of achievement, and they highlighted improvement of patients’ lives as positive. A greater level of responsibility gave the nurses pride in their profession. They had suggestions that could improve training efficiency but were overall satisfied with the training program. Conclusions Our study showed that the nurses were satisfied with the training and that learning a new task led to higher self-esteem and increased respect from patients and colleagues. Suggestions to improve the training were identified; these should be considered before implementation by other departments.
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