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临床试验/NCT04834648
NCT04834648已完成不适用

Operations Research to Improve Timely Referral Flow and Compliance of Diabetic Retinopathy Patients From Peripheral Eye Care Centers to Tertiary Center in Nepal: Cluster Randomised Control Trial

Seva Foundation1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Primary Outcome

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Care Provider)

盲法说明

At LEI the staff will be blinded about the intervention/ control referring centers

入排标准

年龄范围
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Diabetic Retinopathy patients attending the peripheral eye centers linked with LEIRC.

排除标准

  • All referred Diabetic patients who not is willing to be part of the study.

结局指标

主要结局

Primary Outcome

时间窗: 8 months

Percentage of referral compliance before and after intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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