Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04834648 |
| Other study ID # |
LEI/IRC/09/019/20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2021 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Seva Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
An effective referral system helps to ensure a close relationship between all levels of the
health system and ensures clients receive optimum care at the appropriate level and at
affordable cost, and hospital facilities are used optimally and cost-effectively. A referral
system requires consideration of all its important components that can be then adjusted to
the local situation. Being a system, the important components of a referral system are Health
system issues (Service providers, Referral protocols, Communication & transportation
provide), Referring facility& Referral practicalities (Client & their condition, Protocols of
care, Care provider & documents, Referral decision, Outward referral form, Communicate with
referral facility, Client information, Referral register), Referral facility& Referral
practicalities (Client with referral form, Treat the client with the document, Rehabilitation
plan, Back referral form, Feedback to referring facility, Referral register) and Supervision
and capacity building (Referral monitoring, Ensure back referral, Feedback and training to
facility staff and Feedback to central level) ((USAID), 2012).
There are mainly two limitations on referring Diabetic Retinopathy patients. Patient-related
reasons: lack of awareness, belief, cost, distance from screening/ treatment centers,
discomfort from dilating drops, efforts to attend yet another center, fear of laser
treatment, fear of its impact on quality of life and jobs, lack of family support and guilt
surrounding the failure to control blood sugar. Provider-related reasons are poor counseling
and advisory services about ocular complications for patients with diabetes, inefficient call
and recall system, long waiting times for screening or treatment, and complicated referral
mechanism.
Lumbini eye institute is a comprehensive tertiary eye care center in western Nepal. In spite
of 19 peripheral referral centers under it, there is a poor inflow of Diabetic retinopathy
patients as against the estimated disease burden in the catchment area. The objective of our
study is to improve timely referral flow from referring centers and compliance with referral
cases after the intervention. In order to meet our objective, the investigators tend to
implement patient counseling at referral centers, a referral tracking system, and a
fast-track mechanism for patients at base hospitals.
Description:
Background: Changes in lifestyle and a growing number of aging populations have increased the
prevalence of diabetes worldwide. Diabetes imposes a heavy disease burden in both developed
and developing countries (1). Diabetic retinopathy is the commonest microvascular
complication of diabetes and the leading cause of blindness in adults. There are no symptoms
initially; visual impairment is seen in the proliferative stage and in macular involvement.
Vision once lost will never be regained (2). The prevalence of diabetic retinopathy was
10%-50% for Type 1 and 25.2% for Type2. The worldwide prevalence of diabetic retinopathy was
found to be 34.6%. WHO estimates Diabetic retinopathy is responsible for 4.8% of 37 million
cases of blindness throughout the world. Several studies in Nepal showed the prevalence of 9%
to 78%. A study at LEIRC showed PDR and ADED to 34%; this suggests a major blockage of cases
at the tertiary and primary level (2013-2014).
Early diagnosis and treatment are the key components to reduce Diabetic blindness. A
comprehensive set of guidelines (CARE 2019) recommends initial dilatation and comprehensive
eye examination by an optometrist or ophthalmologist. Patient with Mild, Moderate and Severe
Diabetic retinopathy requires a referral and they need reexamination or follow up within time
limit of 3-6 months, less than 3 months and less than 1 month respectively. Incidence of
visual loss secondary to proliferative Diabetic Retinopathy can be reduced by referral to an
ophthalmologist. Multiple studies show laser photocoagulation of new vessels reduces the
incidence of Diabetic Blindness by 60% to 80%.
Lumbini eye institute is a comprehensive tertiary eye care center in western Nepal. In spite
of 19 peripheral referral centers under it, there is a poor inflow of Diabetic retinopathy
patients as against the estimated disease burden in the catchment area. There are mainly two
limitations on referring Diabetic Retinopathy patients. Patient-related reasons: lack of
awareness, belief, cost, distance from screening/ treatment centers, discomfort from dilating
drops, efforts to attend yet another center, fear of laser treatment, fear of its impact on
quality of life and jobs, lack of family support and guilt surrounding the failure to control
blood sugar. Provider-related reasons are poor counseling and advisory services about ocular
complications for patients of diabetes, inefficient call and recall system, long waiting
times for screening or treatment, and complicated referral mechanism (2). Considering these
reasons and problem tree analysis effective interventions designed. Counseling and telephonic
follow-up at referring facility; fast track system at the base hospital. The objective of our
study is to improve timely referral flow from referring centers and compliance with referral
cases after the intervention.
Methods:
Study Design: Two arm parallel, cluster Randomised control trial with allocation ratio 1:1
will be used.
Study Setting :
All diabetic retinopathy patients attending peripheral eye care centers will be the study
population.
Lumbini Eye Institute and Research Center (LEIRC) - a comprehensive tertiary referral eye
care center located in the Western part of Nepal has nineteen referring centers: five
secondary eye hospitals (SEC), three district eye care centers (DECC), and eleven primary eye
care centers (PECC). The referral center (LEIRC) has several sub-specialty services; the
Retina department is well equipped with two consultants, one retina fellow, and one separate
counselor. A secondary eye hospital has a general ophthalmologist, ophthalmic paramedical
personnel (optometrist/ophthalmic assistant), and a counselor with limited diagnostic tools
for diabetic retinopathy (DR). A primary/district eye care center has ophthalmic paramedical
personnel (optometrist/ophthalmic assistant) and an optician with a direct ophthalmoscope for
retina examination.
Masking: At LEI the staff will be blinded about the intervention/ control referring centers.
Data collection plan: An experienced team member will be responsible for data collection and
telephonic follow-up. the project coordinator will be trained thoroughly trained on the
completion of the data collection form Data Management Plan: The demographic information and
other variables of the patient who are referred from peripheral eye care centers will be
collected and entered in an excel sheet. One of the team members will be responsible for data
management.
Data Analytic plan: Data will be analyzed using IBM SPSS. Differences indifference in
compliance and referral rates will be computed.
Study period: Approximately 19 months (March 2020 to December 2021) Ethical consideration:
Ethical approval is taken from the Institutional review committee, LEIRC. Data
confidentiality will be maintained.
Ethical considerations:
Written Consent form including the title of the study and their support during the study
period was sent to all 10 centers included in the study. These consent forms were signed by
the head of centers on 12th June 2020 and sent to LEIRC. Ethical Approval from the
Institutional Review Committee (IRC) of LEIRC was taken on 8th August 2020. Data
confidentiality will be maintained. No personal information will be used in analysis,
reports, and publications.
Discussion:
Diabetic Retinopathy is a global epidemic in both developed and developing countries with
significant morbidity and mortality. In a study done by Mishra SK et al, they found people
were less aware of the microvascular complications of diabetes. They didn't meet the
physician regularly for diabetes control and didn't know about regular eye examinations with
ophthalmologists. Even though the incidence of blindness secondary to diabetes mellitus can
be significantly reduced; there is still a large number of diabetes patient with vision loss
due to retinal complications of the disease In a study done by Tien Y. Wang et al, they came
with a broad-based system-level approach to prevent vision loss resulting from Diabetic
Retinopathy: 1: Targeted health care education to improve public knowledge. 2:
well-implemented community or national level screening programs for all patients with
diabetes. 3: Timely referral for severe level of Diabetic Retinopathy. 4: Appropriate
treatment for advanced Diabetic Retinopathy (PDR and DME).
In our study the investigators wanted to make the patient aware of the changes diabetes can
bring to the eye, the investigators implemented Structured Counseling where the patient is
explained in detail about the changes diabetes makes in the eye. It also includes the impact
on vision and different treatment options available and the rate. They are also explained to
go to a base hospital where they will be evaluated by a retina specialist thus decreasing a
load of visual impairment due to diabetes.
World Health Organization (WHO) has identified adherence to follow-up services as a key
component in effective management of Diabetic Retinopathy9. In this study, they found
improving the clarity of the referral process by explaining the treatment costs, the reason
for referral, and likely health benefits to the patient helped by increasing follow-up
rates9. Keeping this in the investigators explained the treatment cost and about the base
hospital in detain as our structured counseling. A study done by Mishra SK et al found major
facilitator was the existence of referral slips to expedite treatment upon reaching the
health facility and the major barrier was a failure to receive preferential treatment at the
facility, despite the presence of the slip. In addition to this, they found lack of feedback
as a barrier to functional referral system 3.
Similarly, during our problem tree analysis, the investigators found a longer waiting time
and no preferential treatment as a factor in the referral system. The investigators tried
implementing a referral slip and planned to decrease the waiting time by allowing them to
visit the ophthalmologist directly at our center. This point will also be explained by the
counselor during counseling.
