Independent Prescribing Optometrists in Acute Ophthalmic Services

NCT02585063 | Completed

• 1 other identifier: DT001
• Study Type: observational
• Target: 321
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eye Abnormalities

Keywords

independent prescribing,; optometrist; acute care

Outcome Measures

Primary Outcomes (1)

• Prescribing decision

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

  Through study completion - up to 18 months

Study Arms (1)

Dual assessment

Where there is time and space, participants will be allocated to have a clinical assessment by the IP optometrist during their wait for the clinical assessment with the ophthalmologist. Both clinical assessments are needed to obtain measurement of agreement. There is no intervention. but participants have two clinical assessments rather than just one.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be invited to take part in the study and given the study information either while being triaged in the walk-in, nurse-led Emergency Eye Centre (EEC) to the appointments-based Acute Referral Clinic (ARC) or at arrival at ARC. An approved poster will advertise the study and will be place on the wall in both ARC and EEC. There will be a smaller version on the reception desk at both ARC and EEC accompanied by a participant information leaflet.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aston University: lead
• Manchester Royal Eye Hospital: collaborator

Study Sites (1)

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Eye Abnormalities

Condition Hierarchy (Ancestors)

Eye Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Cindy Tromans, PhD

  Manchester Royal Eye Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 23, 2015
• Study Start: December 1, 2015
• Primary Completion: December 13, 2017
• Study Completion: September 12, 2018
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

GB (1)