PRISSM (Perfecting Refraction in India With Superior Service Models): A Cluster-randomized Controlled Trial of Three Models of School-based Spectacle Service Delivery in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 3
- 主要终点
- Program cost-effectiveness
研究概览
简要总结
Some programs do the screening, refraction testing and provision of spectacles to children entirely in the school setting ("School Model"). One strength of such programs is that most children at school who need spectacles get them. However, sustainability is poor, because spectacles cannot be sold in many schools and there may be too few refractionists to cover all schools in most countries. Other programs provide vision screening at schools but refer children who fail vision screening to nearby facilities for refraction and distribution/sale of spectacles ("Referral Model"). This model's strengths include a lower demand for refractionists and opportunities for the spectacles to be sold. However, a disadvantage is that most of the referred children do not attend the specialist facility. One way to improve this might be to enhance the Referral Model and a recent USAID review by Priya Reddy and Ken Bassett showed that involving teachers in vision screening and family counseling significantly increases children's use of spectacles. Therefore, at 141 schools in India, involving over 42,300 children (assuming a minimum of 300 children/school), the investigators will study an "Improved Referral Model," with strong teacher involvement, to investigate the potential benefits of combining the lower costs of the "Referral Models" with the high uptake of the "School Model". The investigators will also assess the effects of allowing parents to purchase enhanced spectacles, rather than having their child use free spectacles. Children will be randomized by the school to the "School Model," "(Improved) Referral Model" or the "(Improved) Referral Model + Cost Recovery (sale of "upgrade spectacles" alongside offering free spectacles. The main study outcome will be program cost-effectiveness, defined as the program cost per child identified with correctable refractive error, who receives spectacles, and wears them at an un-announced visit between 8 to 12 weeks after distribution. Profit on spectacles sold in the "Referral + Cost Recovery" group will be subtracted from the program costs in this study group. The groups will be compared, with and without adjustment for baseline characteristics.
详细描述
Background
Need: The leading cause of vision impairment among children in India, and in the world more widely, is an uncorrected refractive error (URE). For example, the population-based Refractive Error Studies in Children (RESC) studies found that 61% of vision impairment in rural children and 89% in urban children in India was due to URE and that as few as 10% of rural and 35% of urban children who need spectacles actually had them. The impact of this shortfall in service delivery is highlighted by recent randomized trials in Asia showing that provision of spectacles significantly improves children's educational outcomes, and the shortcoming in India is particularly important because India has the highest number children of any other country.
Potential impact: This trial has the potential to impact on at least two of the Sustainable Development Goals (SDG) of the United Nations. Although interventions to prevent myopia, such as topical anti-muscarinic therapy and increased time outdoors, show much promise, they are not yet ready for large-scale use. Until then, school vision programs remain the principle tool to address the problem of URE in India and elsewhere, and thereby improving children's access to high-quality education (SDG #4) and helping to address unequal access of girls to healthcare services affecting vision (SDG #5). In fact, the Indian government and many private entities are already taking a very active role in school vision screening. Since the onset of the Sarva Shiksha Abhiyan (Education for All) program in 2002, many millions of children have undergone school vision screening, but refraction and spectacles distribution has been limited and much more could be done to help. To sustain and expand these efforts, more cost-effective approaches are needed.
Problems with current models: Many non-governmental organization (NGO) and government spectacle distribution programs in India and elsewhere use school-based vision screening, refraction, and provision of spectacles. This is particularly true in poorer, rural or other under-served areas. The greatest strength of such programs is that they deliver refractive services and spectacles to a large proportion of children requiring them when school attendance rates are high. However, sustainability is problematic: these programs usually deliver spectacles for free, because their sale is not permitted in many schools. Further, this model is very demanding on resources, because refractionists must travel to numerous schools in their catchment area. Finally, it has been suggested that long-term compliance with spectacle wear may be higher when families make at least some contribution to spectacle costs, although evidence for this assertion is lacking.
Alternatively, other programs, particularly those in urban or better-served areas, may provide vision screening at schools, but then refer children and families failing to screen to a nearby facility for refraction and distribution or sale of spectacles. The strength of this model is that it is less demanding of resources (refractionists remain at their base facility rather than being directly involved in outreach screening) and spectacle sales at medical facilities are often more acceptable than sales in schools. Therefore, this model may be more sustainable. However, program experience and research have shown up to two-thirds of the referred children/families do not attend the facility that they are referred to.
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 (Investigator)
盲法说明
Cluster-randomised, investigator-masked trial. Investigators assessing the components of the main study outcome will be masked to the study group assignment of the school.
Staff assessing data for the main outcome will be masked to a child's group assignment.
入排标准
- 年龄范围
- 10 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility: Enrolment criteria:
- •Children in randomly-selected 6th to 10th grades in selected schools with presenting visual acuity <= 6/9.6 (0.2 LogMAR) in either eye.
- •Children who already own spectacles will be requested to bring their spectacles on the day of screening, and children whose vision with existing spectacles meets study criteria will be eligible.
- •Entry into the trial only requires that a child fail vision screening, which is assessed in the same way for all three randomized groups.
排除标准
- •Parents returning the form indicating they do not wish their child to participate;
- •no Vision Center within 50 km of the child's home (a rare occurrence in the REACH network).
- •If the child is incapable of completing visual acuity screening in both eyes for any reason.
研究组 & 干预措施
School Model
School Model (n=47 schools): Vision screening will be carried out by the vision screeners; refraction will be done at the schools by refractionists, and children who need them will be given free spectacles at the school within two weeks.
干预措施: School Model (Other)
Referral Model
Referral Model (47 schools): Vision screening carried out by the vision screeners, and children are referred to nearby Vision Center/ secondary center for refraction and delivery of free spectacles. Teachers will contact families not presenting for follow-up care and for spectacle compliance through SMS, phone call and notations in the school diary.
干预措施: Referral Model (Other)
Referral Model + Cost Recovery
Referral Model + Cost Recovery (47 schools): Vision screening carried out by the vision screeners; children referred to Vision Center for refraction and delivery of spectacles with an option to purchase "upgrade spectacles" (which was shown to be appealing to families in the recent PRICE study. These spectacles have scratch-proof coatings and designs selected to appeal to local children. Teachers will contact families not presenting for follow-up care and for spectacle compliance through SMS, phone call and notations in the school diary.
干预措施: Referral Model + Cost Recovery (Other)
结局指标
主要结局
Program cost-effectiveness
时间窗: 13 months
Program cost per child identified with correctable refractive error, who receives spectacles and wears them at an un-announced visit 8 to 12 weeks after distribution. Income from sales of spectacles in the "Referral + Cost Recovery" group will be subtracted from the program costs. The groups will be compared, with and without adjustment for baseline characteristics.
次要结局
- Purchase rates of upgrade spectacles in the Referral + Cost Recovery Group(12 months)
- Proportion of children receiving spectacles who are wearing them at the time of un-announced visit between 8 and 12 weeks(12 months)
- Teacher and student reports of rates of teacher interventions in the two Referral groups(12 months)
研究者
Congdon Nathan
Professor
Queen's University, Belfast
