Improve Timely Referral Flow and Compliance of Diabetic Retinopathy Patients
Condition: Diabetes; Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Structured Counseling
Intervention type(s): Behavioral
Intervention description(s): Structured Counseling, which includes A. Counseling is done by a trained counselor
B. Telephonic Follow up:
C. Development of Fast Track system at the Base Hospital. D. Provide Health Education Material to all Diabetic Patients. E. Referral communication and feedback between referring and referral facility.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: referral rate; diabetic retinopathy; counselling