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临床试验/NCT04800718
NCT04800718已完成不适用

Effect of Door-to-door Screening and Awareness Generation Activities in the Catchment Areas of Vision Centers on Service Utilization; a Randomized Experimental Intervention

Seva Foundation1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年2月22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
1,500
试验地点
1
主要终点
Increase in numbers of walk in patients at VC from baseline

研究概览

简要总结

Background: Vision Centre (primary eyecare facility): a major eye care service model catering to underserved rural areas. The sustainability of rural Vision Centres (VC) in north India is a major challenge due to the under-utilization of services by the local community and stakeholders. This affects self-sustainability and limits the expansion of services in rural areas. Dr. Shroff's Charity Eye Hospital is planning an intervention: door-to-door screening in VC's vicinity areas, to connect with the community.

In this operational research, the investigators plan to study if this intervention package, consisting of door-to-door screening and awareness generation in the service area can increase the utilization of VC services to a minimum of 14 out-patient cases per day within the study period and also analyze its cost-effectiveness for scalability.

Methodology: The study is a randomized experimental intervention, consisting of 2 VCs (intervention arm and control arm) selected from poor low-performing VCs i.e. walk-in out-patient cases≤ 10 per day, in two operational regions (Vrindavan, Mathura District, and Mohammadi, Kheri District) of Uttar Pradesh. Intervention includes door-to-door screening and awareness generation in 8-12 villages surrounding the VC. The control VC will follow existing practices of awareness generation through community activities and health talks. Data collected from each VC for the 4 months of intervention will include, a number of walk-in patients, spectacles advised, and their uptake, referral, and uptake for cataract and specialty surgery as well as operational expenses. Differences across arms in terms of the number of walk-in patients, referrals, uptake of services, and costs involved would be analyzed.

Conclusion: Through this study, the investigators would analyze if our intervention package is effective in increasing the VC service utilization and thus, overall sustainability. The investigators would also study the cost-effectiveness of this intervention, to assess its scalability.

详细描述

The Global Action Plan for Universal Eye Health emphasizes the importance of providing basic eyecare to all individuals, & the communities they constitute, at affordable rates. In India, PEC is delivered through two main mechanisms. Transient screening camps and permanent facilities- vision centers (VCs) with catchment areas of roughly 50,000 people, located in rural areas & urban slums & accessible by public transport. They refract, diagnose & treat minor eye conditions & refer cases needing further care to their nearest base hospital. The literature on barriers to PEC in India is limited but points to lack of knowledge about eye diseases, detrimental social stigmas, low priority being accorded to eye problems, gender discrimination, unaffordability, lack of perceived need as well as immobility & dependence on escorts. These barriers potentially affect the operational sustainability of VCs-in large part by the number of walk-in patients. Our organization is a network of eye care delivery mechanisms based on the pyramidal model; spread across north India. 36 VCs (9 urban & 27 rural) are under operation; raising awareness, providing refraction, recognition & referral services to their catchment population & increasing contact of those in need of services. For the majority of people, these are the first point of contact when accessing or attempting to access eye care services. Developing trust & high referrals to these VCs, from the entire catchment population they service, is essential for the overall sustainability of these centers & to increase the ambit of PEC delivery. This protocol aims to study the effect of an intervention combining door-to-door screening with regular awareness activities in the catchment population on the service utilization at VCs.

Study Design & Process: Randomized experimental intervention, in which four VCs are selected: two each in the intervention & control arms (one each from a particular operational area). Our organization has 6 secondary centers (SCs), of which 4 are located in the state of Uttar Pradesh, namely, Meerut, Mathura, Saharanpur & Kheri. These regions have a total of 23 VCs operating in rural & semi-urban areas, together serving around 1 million people. Of these 4 SCs, 2 were selected (Vrindavan in Mathura district & Mohammadi in Kheri district) for this study based on feasibility & the demographic profile of their catchment population. The Vrindavan region has 8 VCs delivering eyecare services in its' semi-urban areas while the Mohammadi region has 6 VCs (5 rural & 1 semi-urban). Most of these VCs have been operational for over 3 years. However, the previous year's data indicated that 80% of VCs as sub-optimal in performance. The sub-optimal VCs were listed. From a total of 10 VCs (5 in each region, meeting the inclusion/exclusion criteria), 2 were randomly selected from each: one each for the control & intervention arms. The VCs in the 2 blocks of the Mathura district were located at Chhata & Raya, respectively, while the 2 VCs from 2 blocks of Kheri district were located at Mitauli & Pashgaon. Due to the nature of the study, it was impossible to mask the field staff to the intervention.

Inclusion/Exclusion Criteria: The regional team gathered detailed information regarding all VCs operating in the Vrindavan & Mohammadi region. VCs were included based on the following criteria:

Low performance (walk-in OPD ≤ 10/day) Duration of operation >1 year Presence of 1 VC in each arm from selected VCs VCs with a walk-in OPD greater than 10 per day & those in operation for less than one year were excluded.

Study Setting: Mathura district has a population of about 2.5 million, 70% resident in rural areas. Kheri district has a population of 4 million- 88% residents in rural areas. Chhata block, in Mathura, has 81 villages with 30 within 10km of the VC. These 30 have a combined population of 70,000. On the other hand, Raya block has 124 villages with 90 within 10km of the VC, having a combined population of 130,000. In Kheri, the Mitauli block has 138 villages with 75 within 10km of the VC. The combined population is around 111,000. Pashgaon block has 230 villages with 85 within 10km of the VC, a population of around 110,000.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • VCs were included based on the following criteria:
  • Low performance (walk-in OPD ≤ 10/day)
  • Duration of operation >1 year
  • Presence of 1 VC in each arm from selected VCs

排除标准

  • VCs with a walk-in OPD greater than 10 per day & those in operation for less than one year were excluded.

结局指标

主要结局

Increase in numbers of walk in patients at VC from baseline

时间窗: 4 months

Increase in numbers of walk in patients at VC from baseline 7-8 walk in patients to 14 per day after the intervention period of four months

次要结局

  • Cost-effectiveness(3 months)
  • Uptake of services(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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