Skip to main content
Top
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Edith E. Holloway, Marios Constantinou, Jing Xie, Eva K. Fenwick, Eric A. Finkelstein, Ryan E. K. Man, Michael Coote, Jonathan Jackson, Gwyn Rees, Ecosse L. Lamoureux

Published in: Trials | Issue 1/2018

Login to get access

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, ACTRN12615000587​505. Registered on 4 June 2015 – retrospectively registered.
Appendix
Available only for authorised users
Literature
1.
go back to reference Stevens GA, White RA, Flaxman SR, et al. Global prevalence of vision impairment and blindness: Magnitude and temporal trends, 1990–2010. Ophthalmology. 2013;120:2377–84.CrossRef Stevens GA, White RA, Flaxman SR, et al. Global prevalence of vision impairment and blindness: Magnitude and temporal trends, 1990–2010. Ophthalmology. 2013;120:2377–84.CrossRef
2.
go back to reference Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2011;96:614–8.CrossRef Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2011;96:614–8.CrossRef
3.
go back to reference Lee JS, Hui E, Chan F, Chi I, Woo J. Associated factors of falls in nursing home residents in Hong Kong and the role of restraints: a cross-sectional survey using the ResidentAssessment Instrument (RAI). Aging Clin Exp Res. 2008;20:447–53.CrossRef Lee JS, Hui E, Chan F, Chi I, Woo J. Associated factors of falls in nursing home residents in Hong Kong and the role of restraints: a cross-sectional survey using the ResidentAssessment Instrument (RAI). Aging Clin Exp Res. 2008;20:447–53.CrossRef
4.
go back to reference Becker C, Loy S, Sander S, Nikolaus T, Rißmann U, Kron M. An algorithm to screen long-term care residents at risk for accidental falls. Aging Clin Exp Res. 2005;17:186–92.CrossRef Becker C, Loy S, Sander S, Nikolaus T, Rißmann U, Kron M. An algorithm to screen long-term care residents at risk for accidental falls. Aging Clin Exp Res. 2005;17:186–92.CrossRef
5.
go back to reference Lamoureux EL, Fenwick E, Moore K, Klaic M, Borschmann K, Hill K. Impact of the severity of distance and near-vision impairment on depression and vision-specific quality of life in older people living in residential care. Invest Ophthalmol Vis Sci. 2009;50:4103–9.CrossRef Lamoureux EL, Fenwick E, Moore K, Klaic M, Borschmann K, Hill K. Impact of the severity of distance and near-vision impairment on depression and vision-specific quality of life in older people living in residential care. Invest Ophthalmol Vis Sci. 2009;50:4103–9.CrossRef
6.
go back to reference de Winter LJ, Hoyng CB, Froeling PG, Meulendijks CF, van der Wilt GJ. Prevalence of remediable disability due to low vision among institutionalised elderly people. Gerontology. 2004;50:96–101.CrossRef de Winter LJ, Hoyng CB, Froeling PG, Meulendijks CF, van der Wilt GJ. Prevalence of remediable disability due to low vision among institutionalised elderly people. Gerontology. 2004;50:96–101.CrossRef
7.
go back to reference Jung S, Coleman A, Weintraub NT. Vision screening in the elderly. J Am Med Dir Assoc. 2007;8:355–62.CrossRef Jung S, Coleman A, Weintraub NT. Vision screening in the elderly. J Am Med Dir Assoc. 2007;8:355–62.CrossRef
8.
go back to reference Nottle H, McCarty C, Hassell J, Keeffe J. Detection of vision impairment in people admitted to aged care assessment centres. Clin Exp Ophthalmol. 2000;28:162–4.CrossRef Nottle H, McCarty C, Hassell J, Keeffe J. Detection of vision impairment in people admitted to aged care assessment centres. Clin Exp Ophthalmol. 2000;28:162–4.CrossRef
9.
go back to reference Mitchell P, Hayes P, Wang JJ. Visual impairment in nursing home residents: the Blue Mountains Eye Study. Med J Aust. 1997;166:73–6.PubMed Mitchell P, Hayes P, Wang JJ. Visual impairment in nursing home residents: the Blue Mountains Eye Study. Med J Aust. 1997;166:73–6.PubMed
10.
go back to reference VanNewkirk MR, Weih L, McCarty CA, Taylor HR. Cause-specific prevalence of bilateral visual impairment in Victoria, Australia: the Visual Impairment Project. Ophthalmology. 2001;108:960–7.CrossRef VanNewkirk MR, Weih L, McCarty CA, Taylor HR. Cause-specific prevalence of bilateral visual impairment in Victoria, Australia: the Visual Impairment Project. Ophthalmology. 2001;108:960–7.CrossRef
11.
go back to reference Owsley C, McGwin G, Scilley K, Meek GC, Seker D, Dyer A. Effect of refractive error correction on health-related quality of life and depression in older nursing home residents. Arch Ophthalmol. 2007;125:1471–7.CrossRef Owsley C, McGwin G, Scilley K, Meek GC, Seker D, Dyer A. Effect of refractive error correction on health-related quality of life and depression in older nursing home residents. Arch Ophthalmol. 2007;125:1471–7.CrossRef
13.
go back to reference Sainz-Gómez C, Fernández-Robredo P, Salinas-Alamán Á, et al. Prevalence and causes of bilateral blindness and visual impairment among institutionalized elderly people in Pamplona, Spain. Eur J Ophthalmol. 2010;20:442–50.CrossRef Sainz-Gómez C, Fernández-Robredo P, Salinas-Alamán Á, et al. Prevalence and causes of bilateral blindness and visual impairment among institutionalized elderly people in Pamplona, Spain. Eur J Ophthalmol. 2010;20:442–50.CrossRef
14.
go back to reference Lamoureux EL, Pallant JF, Pesudovs K, Rees G, Hassell JB, Keeffe J. The effectiveness of low-vision rehabilitation on participation in daily living and quality of life. Invest Ophthalmol Vis Sci. 2007;48:1476–82.CrossRef Lamoureux EL, Pallant JF, Pesudovs K, Rees G, Hassell JB, Keeffe J. The effectiveness of low-vision rehabilitation on participation in daily living and quality of life. Invest Ophthalmol Vis Sci. 2007;48:1476–82.CrossRef
15.
go back to reference Stelmack J. Quality of life of low-vision patients and outcomes of low-vision rehabilitation. Optom Vis Sci. 2001;78:335–42.CrossRef Stelmack J. Quality of life of low-vision patients and outcomes of low-vision rehabilitation. Optom Vis Sci. 2001;78:335–42.CrossRef
16.
go back to reference Bailey IL, Lovie-Kitchin JE. Visual acuity testing. From the laboratory to the clinic. Vis Res. 2013;90:2–9.CrossRef Bailey IL, Lovie-Kitchin JE. Visual acuity testing. From the laboratory to the clinic. Vis Res. 2013;90:2–9.CrossRef
17.
go back to reference Jorm AF, Mackinnon AJ, Henderson AS, et al. The Psychogeriatric Assessment Scales: a multi-dimensional alternative to categorical diagnoses of dementia and depression in the elderly. Psychol Med. 1995;25:447–60.CrossRef Jorm AF, Mackinnon AJ, Henderson AS, et al. The Psychogeriatric Assessment Scales: a multi-dimensional alternative to categorical diagnoses of dementia and depression in the elderly. Psychol Med. 1995;25:447–60.CrossRef
18.
go back to reference Thylefors B, Chylack LT Jr, Konyama K, et al. A simplified cataract grading system. Ophthalmic Epidemiol. 2002;9:83–95.CrossRef Thylefors B, Chylack LT Jr, Konyama K, et al. A simplified cataract grading system. Ophthalmic Epidemiol. 2002;9:83–95.CrossRef
19.
go back to reference McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010;51:5537–45.CrossRef McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010;51:5537–45.CrossRef
21.
go back to reference Lamoureux EL, Pallant JF, Pesudovs K, Hassell JB, Keeffe J. The impact of the vision impairment questionnaire: An evaluation of its measurement properties using Rasch analysis. Invest Ophthalmol Vis Sci. 2006;47:4732–41.CrossRef Lamoureux EL, Pallant JF, Pesudovs K, Hassell JB, Keeffe J. The impact of the vision impairment questionnaire: An evaluation of its measurement properties using Rasch analysis. Invest Ophthalmol Vis Sci. 2006;47:4732–41.CrossRef
22.
go back to reference Lamoureux EL, Pallant JF, Pesudovs K, Rees G, Hassell JB, Keeffe J. The impact of vision impairment questionnaire: An assessment of its domain structure using confirmatory factor analysis and Rasch analysis. Invest Ophthalmol Vis Sci. 2007;48:1001–6.CrossRef Lamoureux EL, Pallant JF, Pesudovs K, Rees G, Hassell JB, Keeffe J. The impact of vision impairment questionnaire: An assessment of its domain structure using confirmatory factor analysis and Rasch analysis. Invest Ophthalmol Vis Sci. 2007;48:1001–6.CrossRef
23.
go back to reference Bellis AD, Williams J. The Cornell Scale for Depression in Dementia in the context of the Australian Aged Care Funding Instrument: a literature review. Contemp Nurse. 2008;30:20–31.CrossRef Bellis AD, Williams J. The Cornell Scale for Depression in Dementia in the context of the Australian Aged Care Funding Instrument: a literature review. Contemp Nurse. 2008;30:20–31.CrossRef
24.
go back to reference Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell scale for depression in dementia. Biol Psychiatry. 1988;23:271–84.CrossRef Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell scale for depression in dementia. Biol Psychiatry. 1988;23:271–84.CrossRef
25.
go back to reference EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.CrossRef EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.CrossRef
26.
go back to reference Linacre JM. A user’s guide to Winsteps: Rasch-Model Computer Program. Chicago: MESA Press; 2002. Linacre JM. A user’s guide to Winsteps: Rasch-Model Computer Program. Chicago: MESA Press; 2002.
27.
go back to reference Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale: Lawrence Erlbaum Associates, Inc.; 1988. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale: Lawrence Erlbaum Associates, Inc.; 1988.
28.
go back to reference Kerry SM, Bland JM. The intracluster correlation coefficient in cluster randomisation. BMJ. 1998;316:1455–60.CrossRef Kerry SM, Bland JM. The intracluster correlation coefficient in cluster randomisation. BMJ. 1998;316:1455–60.CrossRef
29.
go back to reference Finkelstein EA, Wittenborn JS, Farris RP. Evaluation of public health demonstration programs: the effectiveness and cost-effectiveness of WISEWOMAN. J Women’s Health. 2004;13:625–33.CrossRef Finkelstein EA, Wittenborn JS, Farris RP. Evaluation of public health demonstration programs: the effectiveness and cost-effectiveness of WISEWOMAN. J Women’s Health. 2004;13:625–33.CrossRef
30.
go back to reference Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ. 2000;320:1197–200.CrossRef Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ. 2000;320:1197–200.CrossRef
31.
go back to reference Fenwick E, Byford S. A guide to cost-effectiveness acceptability curves. Br J Psychiatry. 2005;187:106–8.CrossRef Fenwick E, Byford S. A guide to cost-effectiveness acceptability curves. Br J Psychiatry. 2005;187:106–8.CrossRef
32.
go back to reference Owsley C, McGwin G, Scilley K, Meek GC, Seker D, Dyer A. Impact of cataract surgery on health-related quality of life in nursing home residents. Br J Ophthalmol. 2007;91:1359–63.CrossRef Owsley C, McGwin G, Scilley K, Meek GC, Seker D, Dyer A. Impact of cataract surgery on health-related quality of life in nursing home residents. Br J Ophthalmol. 2007;91:1359–63.CrossRef
33.
go back to reference Teresi J, Morse AR, Holmes D, Yatzkan ES. Impact of a vision intervention on the functional status of nursing home residents. J Vis Impair Blind. 2005;99:96–108. Teresi J, Morse AR, Holmes D, Yatzkan ES. Impact of a vision intervention on the functional status of nursing home residents. J Vis Impair Blind. 2005;99:96–108.
34.
go back to reference Dwyer T, Craswell A, Rossi D, Holzberger D. Evaluation of an aged care nurse practitioner service: quality of care within a residential aged care facility hospital avoidance service. BMC Health Serv Res. 2017;17:33.CrossRef Dwyer T, Craswell A, Rossi D, Holzberger D. Evaluation of an aged care nurse practitioner service: quality of care within a residential aged care facility hospital avoidance service. BMC Health Serv Res. 2017;17:33.CrossRef
35.
go back to reference Clark S, Parker R, Prosser B, Davey R. Aged care nurse practitioners in Australia: evidence for the development of their role. Aust Health Rev. 2013;37:594–601.CrossRef Clark S, Parker R, Prosser B, Davey R. Aged care nurse practitioners in Australia: evidence for the development of their role. Aust Health Rev. 2013;37:594–601.CrossRef
37.
go back to reference Commonwealth of Australia. Living Longer. Living Better. Canberra: Commonwealth of Australia; 2012. Commonwealth of Australia. Living Longer. Living Better. Canberra: Commonwealth of Australia; 2012.
Metadata
Title
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
Authors
Edith E. Holloway
Marios Constantinou
Jing Xie
Eva K. Fenwick
Eric A. Finkelstein
Ryan E. K. Man
Michael Coote
Jonathan Jackson
Gwyn Rees
Ecosse L. Lamoureux
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3025-5

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue