跳至主要内容
临床试验/NCT02585063
NCT02585063已完成不适用

Independent Prescribing Optometrists in Acute Ophthalmic Services

Aston University1 个研究点 分布在 1 个国家目标入组 321 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
321
试验地点
1
主要终点
Prescribing decision

研究概览

简要总结

The UK government's Crown report titled 'Review of prescribing, supply & administration of medicines' enabled optometrists to train for the qualification of independent prescribing (IP). The UK introduced IP for optometrists in 2009. The proposed research focuses on the role of IP optometrist in the acute ophthalmic services of Manchester Royal Eye Hospital (MREH). The study will compare IP optometrists to consultant ophthalmologists in the ability to diagnose, manage and prescribe medication for patients accessing these services.

To achieve this comparison consenting participants will first have a clinical assessment with the IP Optometrist, where findings including diagnosis and management plan will be recorded onto a research proforma. The consultant ophthalmologist will be masked to the IP Optometrist's research proforma to prevent bias. The consultant ophthalmologist will then perform a clinical assessment on a second proforma and inform the participant of their diagnosis and management plan. Percentage agreement, kappa (κ) and weighted κ will be calculated for a range of parameters between the two proformas. Disagreement in diagnosis or management will be arbitrated by a separate ophthalmologist participating in the study with a specialty relevant to the participant's condition.

The main objective of the research is to expand the limited base of evidence of of IP optometrists' ability to diagnose, manage and prescribe medication and to determine whether they work at least as safely and effectively as consultant ophthalmologists in acute ophthalmic services. It is the first study in this area since the advent of IP for optometrists, with only one previous study published before IP was introduced. The research will enable the type and frequency of conditions presenting in these services to be measured. Furthermore it will identify conditions that IP optometrists can manage independently and enable guidelines for these conditions to be developed.

详细描述

What are the purpose and objectives of the research?

The primary aim of this prospective, masked, controlled comparative study is to measure the agreement in diagnosis between IP optometrists and the reference standard of consultant ophthalmologists.

A secondary aim is to measure agreement in management of the diagnosis, including the decision whether or not to prescribe medication. The choice of not prescribing medication is an important prescribing decision and will be counted as such. This measure is the novel aspect of the research as it provides evidence of IP optometrists' ability to safely prescribe.

What is the scientific justification for the research?

The NHS's emergency services are experiencing increasing demand (Ismail et al 2013), which is also true of MREH's Acute Referral Centre where IP optometrists work as part of a multidisciplinary team. There is a scientific need to provide an evidence base to validate and support the role of optometrists working in acute ophthalmic services, as well as provide evidence of IP optometrist's ability to safely prescribe medication. This evidence base may in turn lend support to nationally extending the role of IP Optometrists' and their skills to the benefit of the Health Service. Establishing an audit meets the clinic need to monitor performance of IP optometrists working in this extended role. Guidelines for IP optometrists working within MREH Acute Ophthalmic Services offer a way to optimise the running of the clinic as patient can be triaged to clinicians and ophthalmologists feed to see complex cases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients referred to MREH's Acute Referral Clinic. Referrals to ARC may be by MREH's nurse led Emergency Eye Centre, by optometrists in the community, by general practitioners, by other medical specialist or by patients with known uveitis (an inflammatory eye condition that may be recurrent).
  • Adult patients invited within the Emergency Eye Centre.
  • Adult patients with capacity for informed consent and willingness to participate.
  • Adult patients who are English speaking.

排除标准

  • Patients under the age of 18 years.
  • Patients without capacity or willingness to consent.
  • Patients unable to comply with routine clinical ophthalmic assessments.
  • Patients who require an interpreter.
  • Patients presenting with conditions that require immediate intervention for example; chemical burn or acute angle closure glaucoma.
  • Patients who are prisoners or young offenders.
  • All in-patients as their care is outside of the skills and experience of an optometrist.

结局指标

主要结局

Prescribing decision

时间窗: Through study completion - up to 18 months

The prescribing decisions of ophthalmologists and optometrists will be compared. They will be documented via self-reports.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验