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. 2018 Nov 26;19(1):650.
doi: 10.1186/s13063-018-3025-5.

Improving eye care in residential aged care facilities using the Residential Ocular Care (ROC) model: study protocol for a multicentered, prospective, customized, and cluster randomized controlled trial in Australia

Edith E Holloway  1   2 , Marios Constantinou  1   2 , Jing Xie  1   2 , Eva K Fenwick  3   4 , Eric A Finkelstein  4 , Ryan E K Man  3 , Michael Coote  1   2 , Jonathan Jackson  5   6 , Gwyn Rees  1   2 , Ecosse L Lamoureux  7   8   9   10
Affiliations

Improving eye care in residential aged care facilities using the Residential Ocular Care (ROC) model: study protocol for a multicentered, prospective, customized, and cluster randomized controlled trial in Australia

Edith E Holloway et al. Trials. .

Abstract

Background: Older adults in residential aged care facilities have unnecessarily high levels of vision impairment (VI) which are largely treatable or correctable. However, no current comprehensive eye health service model exists in this setting in Australia. We aimed to determine the clinical, person-centered, and economic effectiveness of a novel eye care model, the Residential Ocular Care (ROC).

Methods/design: This protocol describes a multicentered, prospective, randomized controlled trial. A total of 395 participants with distance vision < 6/12 (0.30 LogMAR) and/or near vision N8 (1.00 M) or worse will be recruited from 38 urban and rural aged care facilities across Victoria, Australia. Aged care facilities will be randomized (1:1) to one of two parallel groups. Participants in the ROC group will receive a comprehensive and tailored eye care pathway that includes, as necessary, refraction and spectacle provision, cataract surgery, low vision rehabilitation, and/or a referral to an ophthalmologist for funded treatment. Usual care participants will be referred for an evaluation to the eye care service associated with the facility or an eye care provider of their choice. The primary outcome will be presenting near and distance vision assessed at the two- and six-month follow-up visits, post baseline. Secondary outcomes will include vision-specific quality of life, mobility, falls, depression, and eye care utilization at two and six months. An incremental cost-effectiveness analysis will also be undertaken.

Discussion: The ROC study is the first multicentered, prospective, customized, and cluster randomized controlled trial in Australia to determine the effectiveness of a comprehensive and tailored eye care model for people residing in aged care facilities. Results from this trial will assist health and social care planners in implementing similar innovative models of care for this growing segment of the population in Australia and elsewhere.

Trial registration: Australian and New Zealand Clinical Trials Registry, ACTRN12615000587505 . Registered on 4 June 2015 - retrospectively registered.

Keywords: Eye care model; Protocol; Residential care; Trial; Vision impairment.

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Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

The study has been approved by the Royal Victorian Eye and Ear Hospital (reference number 15/1232H), Mercy Health (reference number R13-52AC), and the Australian College of Optometry (reference number H14 001) Human Research Ethics Committees. Written informed consent will be obtained from each participant before any study-related procedures.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow and timeline for trial improving eye care in residential aged care facilities using the Residential Ocular Care (ROC) model
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

References

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