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Independent Prescribing Optometrists in Acute Ophthalmic Services

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ClinicalTrials.gov Identifier: NCT02585063
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : January 14, 2021
Sponsor:
Collaborator:
Manchester Royal Eye Hospital
Information provided by (Responsible Party):
Aston University

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.


Condition or disease
Eye Abnormalities

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Study Type : Observational
Actual Enrollment : 321 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Independent Prescribing Optometrists in Acute Ophthalmic Services
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : December 13, 2017
Actual Study Completion Date : September 12, 2018

Group/Cohort
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.



Primary Outcome Measures :
  1. Prescribing decision [ Time Frame: Through study completion - up to 18 months ]
    The prescribing decisions of ophthalmologists and optometrists will be compared. They will be documented via self-reports.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  1. 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).
  2. Adult patients invited within the Emergency Eye Centre.
  3. Adult patients with capacity for informed consent and willingness to participate.
  4. Adult patients who are English speaking.

Exclusion Criteria:

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585063


Locations
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United Kingdom
Manchester Royal Eye Hospital
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Aston University
Manchester Royal Eye Hospital
Investigators
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Study Chair: Cindy Tromans, PhD Manchester Royal Eye Hospital
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Responsible Party: Aston University
ClinicalTrials.gov Identifier: NCT02585063    
Other Study ID Numbers: DT001
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Keywords provided by Aston University:
independent prescribing,
optometrist
acute care
Additional relevant MeSH terms:
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Eye Abnormalities
Congenital Abnormalities
Eye Diseases