Background To assess the clinical and patient-centred effectiveness of a novel residential ocular care (ROC) model in Australian individuals residing in residential care.
Methods In this prospective, multicentred, randomised controlled trial conducted in 38 Australian aged-care facilities (2015–2017), 178 visually impaired individuals living in residential care facilities (mean age ±SD: 83.9±8.6 years; 65.7% women) were cluster randomised to ROC (n=95) or usual care (n=83) pathways. The ROC arm comprised a tailored and comprehensive within-site eye examination and care rehabilitation pathway, while usual care participants were given a referral to an external eyecare provider. Outcomes included presenting distance and near visual acuity (PNVA); Rasch-transformed Reading, Emotional and Mobility scores from the Impact of Vision Impairment questionnaire; quality of vision (QoV comprising Rasch-transformed Frequency, Severity and Bother domains) scores; Euroqol-5-Dimensions (raw scores); Cornell Scale for Depression (raw scores) and 6-month falls frequency, assessed at baseline and 6 months post intervention. Within-group and between-group comparisons were conducted using linear mixed models, adjusted for baseline differences in characteristics between the two arms.
Results At 6 months, intention-to-treat analyses showed significant between-group improvements in ROC residents compared with usual care for PNVA, Emotional and QoV scores (all p<0.05) These significant findings were retained in per-protocol analyses. No other between-group changes were observed.
Conclusion Our ROC model was effective in improving near vision, emotional well-being and perceived burden of vision-related symptoms in residential care dwellers in Australia with vision impairment. Future studies to evaluate the cost effectiveness and implementation of ROC in Australia are warranted.
- clinical trial
- treatment surgery
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Contributors REKM revised the statistical analysis plan and drafted and revised the paper. ATLG cleaned and analysed the data, revised the statistical analysis plan and revised the paper. MC participated in and monitored data collection, cleaned the data and revised the paper. EKF and EH revised the paper. EAF, MC, JJ and GR contributed to trial design, designed the data collection tools and revised the paper. ELL designed the trial, monitored data collection, wrote the statistical analysis plan and revised the paper. He is the guarantor of this paper.
Funding This work was supported by the National Health and Medical Research Council grant (NHMRC #1046689). In addition, Ecosse Lamoureux was supported by a NHMRC Senior Research Fellowship (#1045280) and Eva Fenwick was funded by an NHMRC Early Career Fellowship (#1072987). CERA receives operational infrastructure support from the Victorian Government.
Disclaimer The funding body had no role in study design, collection, management, analysis, and interpretation of data; writing of the manuscript; and the decision to submit the manuscript for publication.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study was approved by the Royal Victorian Eye and Ear Hospital (Reference number 15/1232 hour), Mercy Health (Reference number R13-52AC) and the Australian College of Optometry (Reference Number H14 001) Human Research Ethics Committees.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Due to Australian privacy laws, we are unable to upload participant data into a public repository. Anonymised data are however available upon request, subject to the corresponding author’s approval.
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