Cost-utility and cost-effectiveness of eye-screening in home healthcare in reducing eye complaints from a societal perspective and its health consequences will be investigated over 1 year. A cluster randomized controlled trial (RCT), including an…
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is incidence in clinically relevant progress of 10 letters (2
lines, exceeding measurement error) or more on the Colenbrander-1M visual
acuity chart between baseline and 12 months follow-up. Measurements are
performed in participants' homes by research assistants from Amsterdam UMC at
baseline, after 6 and after 12 months.
Secondary outcome
• Vision-related measures:
- Average visual acuity change in letters per participant and eye between
baseline and 12 months follow-up, including stenopeic visual acuity.
- Number of participants and eyes with baseline visual impairment (visual
acuity 8/24 or lower) with clinically relevant progress of 10 letters or more.
- Optometric status 12 months after baseline. This measurement will be used for
diagnostic purposes indicating whether we may have missed (latent) pathology in
both groups, but also to make sure that all participants will receive eye care
after the study, if necessary.
- Vision-related quality of life: CAT-EyeQ
• Health-related measures:
- Falling accidents and bone fractures: A shortened version of the *fall and
fracture calendar* will be used. Questions are about the number of falls and
fractures in the previous 6 months.
- Depressive symptomatology will be measured with the Patient Health
Questionnaire (PHQ-9) with nine questions corresponding to the Diagnostic
Statistical Manual symptoms for major depressive disorder during the past 2
weeks.
- Health-related quality of life will be investigated with the EuroQol
5-Dimension 5-Level questionnaire (EQ-5D-5L) which covers the dimensions
mobility, self-care, daily activities, pain and discomfort, and anxiety and
depression.
- Wellbeing: The ICEpop CAPability measure for Older people (ICECAP-O) is a
measure of capability in older people for use in economic evaluations.
- Health literacy will be measured with the European Health Literacy Survey
Questionnaire (HLS-EU-Q16).
• Healthcare utilization and cost-effectiveness from a societal perspective:
The institute for Medical Technology Assessment (iMTA) Medical Cost
Questionnaire (iMCQ) will be used to measure health care utilization at
baseline, 6 and 12 months.
• Process evaluation:
Participants from the intervention group, nurses, professionals from home
healthcare services and professionals that participants were referred to after
eye-screening, will be involved in the process evaluation.
Background summary
Having a severe visual impairment or blindness has a significant impact on the
quality of life and social participation of older adults. Visual impairment in
older age can lead to depressive symptoms, falls and fractures, including
second contralateral hip fractures. Visual impairment is one of the barriers to
access health information and an important reason for low health literacy in
older adults, whereas low health literacy is associated with high
hospitalization and emergency room access rates and mortality. A recent
cross-sectional pilot study with one of the largest home healthcare
organizations in the Netherlands (i.e. Buurtzorg Nederland) showed that simple
eye-screening by community nurses helps to detect eye complaints among elderly
people living independently. Of all patients, 20% had a severe visual
impairment with a visual acuity lower than 8/24 of the best eye. In addition,
of all patients who were referred to a general practitioner (GP), optician,
optometrist or ophthalmologist based on this screening (also 20% of the total
group), it was found that almost half had a severe visual impairment whereas
others had eye complaints that had affected acuity to a smaller extent. In most
cases, eye complaints could be treated with spectacles or cataract surgery, but
also untreatable eye diseases were found. These complaints may not have been
detected without eye-screening and treatment would not have been offered. The
number of falls was considerably higher for people with visual impairment (52%
vs. 38%), however, the potential beneficial outcomes of screening on visual
outcomes or quality of life were not investigated.
Study objective
Cost-utility and cost-effectiveness of eye-screening in home healthcare in
reducing eye complaints from a societal perspective and its health consequences
will be investigated over 1 year. A cluster randomized controlled trial (RCT),
including an extensive process evaluation will be combined with an economic
evaluation. This will provide insight into the incremental costs per additional
patient with relevant progress in visual outcomes (i.e. cost-effectiveness
analysis, CEA) versus incremental costs per QALY gained (cost-utility analysis,
CUA) in case of eye-screening plus care as usual versus care as usual only.
Study design
To gain insight into the public support for eye-screening, cost-utility and
cost-effectiveness of nurse-assisted online eye-screening in home healthcare in
reducing eye complaints will be studied from a societal perspective, including
the impact on physical and mental health over 1 years* time. A cluster-RCT
comparing the effects of online screening guided by community nurses in
patients* homes compared to care as usual, and in which both healthcare costs
and societal costs are mapped, will be performed in collaboration with two
large home healthcare organizations. The study will also encompass a process
evaluation to evaluate the online eye-screening from the perspectives of
patients, nurses and home healthcare organizations and referral partners who
will be taking part in the online eye-screening and subsequent intervention
uptake.
Intervention
On top of usual care, nurse-assisted eye-screening takes place with the Easee
app, which is implemented on the tablet or laptop of the community nurse.
Participants will be referred if necessary and after assessment by a contracted
optometrist.
Study burden and risks
Negligible risk. Participants constitute a vulnerable population (65+ who
receive home care for health problems) for whom an intervention is applied (eye
screening via the Easee app, assisted by the nurse). They may be referred to an
optician, optometrist or ophthalmologist based on the results of this eye
screening. If necessary, pupil dilating eye drops will be used at the 12 month
optometric exam. This can blurry the vision of the participants and they can be
extra sensitive to bright light. The effects of dilating eye drops last a few
to several hours.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Patients receive home healthcare for health problems
- 65 years or older (query)
- Understanding of the Dutch language (telephone assessment)
- Cognitive ability to participate in research (telephone assessment: six-item
Mini Mental State Examination score >3)
Exclusion criteria
- Very serious health condition of the patient (query: e.g. terminal illness,
receiving palliative home care)
- Cognitively unable to participate in research (query: e.g. late stage
Alzheimer's, Parkinson's)
- Having received an optometric or ophthalmic consultation within the last 6
months (query and telephone assessment)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78386.018.22 |