Perfecting Refraction in India With Superior Service Models
Condition: Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Potential superiority of optimized Referral Models and improvements for vulnerable children:
      Recent evidence from a review by Reddy and Bassett and trials by Congdon suggest that various
      strategies which increase involvement of teachers in the screening process (parent-teacher
      meetings; short message service (SMS), phone call, or handwritten notes in the students diary
      from teachers to families who do not complete referrals) can significantly increase the
      proportion of families following up for care at an outside eye care facility. Therefore, this
      cluster randomized trial will test an "optimized" model of distribution of spectacles,
      maximizing teacher involvement, to determine whether this approach can achieve comparable
      service uptake to fully school-based models at a greater level of cost-effectiveness.
      High-quality, trial-based evidence that showed that optimized Referral models are both
      low-cost and high-coverage may provide a strong stimulus to scale up refractive service
      programs in India and other low-middle income countries (LMICs). These programs can benefit
      millions of low-income children not currently receiving refractive services, thus improving
      their access to classroom learning.

      This trial will compare two general screening methods: 1. School model and 2. Referral Model.
      A "Cost model", which is built on the Referral model but includes the sale of spectacles,
      will also be included, as a third randomized group. In the School model, refraction occurs at
      the school and spectacles are given to children at the school, which may yield a higher rate
      of compliance, but is more expensive and may not be sustainable. On the other hand, the
      Referral model, where the children are referred to be screened at the vision center or
      service center may have lower compliance but be less expensive and more likely to be
      sustainable. This study examines the hypothesis that greater teacher involvement in screening
      and follow up can improve the compliance of children and families with the examination at the
      service center in the Referral model. For this reason, the main outcome of the trial is
      cost-effectiveness (amount spent per child who receives spectacles that improve his/her
      vision, and which are worn at an un-announced examination visit between 8 to 12 weeks after
      distribution). If the teacher intervention can improve compliance in the Referral model, it
      will most likely be the more cost-effective model. If the teacher's intervention doesn't
      increase compliance in the Referral model, then the School model is likely to be the most
      cost-effective. Because money invested in school screening is wasted when families do not
      comply with referral to the Vision Centre in the Referral model, compliance with a referral
      will be the most important determinant of our main cost-effectiveness outcome.

      Experimental plan Population: School children in the 6th to 10th grades (11-15 years of age)
      at public and private, rural and urban schools with a minimum of 300 students and covered by
      the Orbis India REACH (Refractive Error Among CHildren) program, including those located
      nearer and further from Vision Centers, which will serve as the principle eye care facilities
      in the study.

      Eligibility: Enrolment criteria: Children in randomly-selected 6th to 10th grades in selected
      schools with presenting visual acuity (that is, wearing spectacles if spectacles are owned at
      baseline) <= 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. Exclusion criteria: 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.

      Sample size: At a refractive error prevalence of 3%, with minimum of 200 children/school, 95%
      of children receiving spectacles in the School Model, 40% of children wearing them in both
      the School Model and Referral Model groups at un-announced visit between 8 to 12 weeks , a
      cost of US$1.30 per child screened in the School Model and US$0.80 in the Referral Model (all
      assumptions based on REACH Program data), if 58.5% of families accept referral to receive
      refraction and spectacles in the Referral Model, this would reach the same cost-effectiveness
      as the School Model. A total of 162 schools (54 in each of three groups) across three
      participating hospitals would be sufficient to detect significantly better cost-effectiveness
      of the Referral Model if 65% of families accept referral for refraction/spectacles, which is
      the target in our hypothesis; with a power of 90%, an alpha-error of 0.05, and an
      intracluster correlation coefficient (ICC) (a measure of how similar children are to one
      another within schools: "clustering") of 0.20.

      Randomization: An independent statistician having no contact with participants will generate
      the randomization sequence using a computer system that is inaccessible until after the
      school has agreed to join the trial. Schools will be stratified into two groups as Public and
      private. The schools in each stratified group will be randomly assigned to either the
      intervention (referral models) or control group (school model) in a 1:1:1 ratio with a block
      size of three to ensure balance. After randomization, the schools and the children in them
      will not be masked to their allocated intervention but staff assessing data for the main
      outcome will not know a child's group assignment.

      Data to be acquired at baseline: Child: Age, gender, spectacles ownership, presenting and
      best corrected visual acuity in both eyes; refractive error in both eyes; the distance of
      child's home from nearest Vision Center; brief spectacle attitude questionnaire; brief family
      Socio-Economic Status (SES) questionnaire. Teacher: Brief questionnaire on attitudes and
      knowledge towards spectacles.

      Program: Survey of all program costs for screening and distribution for each model. Our
      cost-effectiveness analysis will be from the Program rather than the societal perspective,
      but the investigators will capture referral patient's travel cost information from
      experienced field workers, in order to perform a sensitivity analysis of the impact of
      including these costs. Regarding programs costs, in the School model, where the optometrist
      team does the screening at school, the program cost will be calculated by taking the cost of
      the primary and secondary screening, cost of the spectacles, and cost of delivering them. In
      the Referral model, the investigators will include the cost of primary screening, secondary
      screening at the vision centers and the cost of spectacles. In the Cost recovery model, the
      cost recovered by selling the spectacles (the difference between retail price and cost of
      spectacles to the hospital) will be subtracted from the program cost. School: Urban versus
      rural, public versus private, size of the school, SES of community, and distance of the
      school from nearest Vision Center.

      Follow-up schedule and follow-up data: Self-reported and observed spectacle wear to be
      ascertained at an un-announced follow-up at school between 8 and 12 weeks after distribution
      of spectacles. The first and second participating hospitals will do 12 weeks follow-up and
      the third participating hospital can only do 8 weeks compliance due to slower delivery to
      their largely-rural schools. Follow-up time will be recorded and analyzed as a potential
      factor affecting our main outcome. Additionally, the following the data for the Referral
      groups will be collected from the referral center and verified from the children in a random
      sample of 10% of children: Did they visit the referral center? Did they receive free
      spectacles? Did they elect to purchase upgrade spectacles? (in the Cost Recovery group).
      Children in the Referral groups not having received spectacles at the referral centers will
      receive them now, and so their visual acuity with spectacles and refractive power in each eye
      will be measured and recorded.

      Data collection: An experienced project coordinator will be responsible for data collection
      and follow-up. The project coordinator will be thoroughly trained on the completion of the
      data collection forms.

      Data Management Plan: The baseline data will be entered and stored in the database
      ("Reachsoft"), which is password protected. Other data for the study will be collected and
      entered by an external data entry operator and sent to the project manager to store it in a
      password-protected system. The collected data will be analyzed in de-identified fashion by
      the study statistician in India.

      A copy of the final study data will be shared with Queen's University Belfast (QUB) under the
      data sharing and protection outlined in a Memorandum of Understanding. The final dataset will
      be stored in the QUB database under QUB custody. The study team will have access to the data
      for research and analyses purposes only. Data will be stored for 5 years after the end of the
      study.

      Data Analytic Plan: Data will be analyzed using STATA 15. The primary and secondary outcomes
      will be compared between the three randomized groups using an intention to treat approach
      with and without adjustment for the baseline child, school and teacher factors listed above.
      Our primary outcome is cost-effectiveness (cost per child identified needing spectacles, who
      gets and is still wearing them 8 to 12 weeks later). The investigators have two hypotheses
      about this primary outcome:

      Primary hypothesis: The improved Referral models which involves teachers contacting families
      will sufficiently improve uptake that the Referral model will be more cost-effective than the
      School model.

      Proposed analysis: Cost per child identified needing spectacles (program perspective, as
      above), who gets and is still wearing them 8 to 12 weeks s later, compared between School and
      Referral model. Both the referral models, where children will be referred to hospital for
      detailed examination, will be combined and compared with the school model, where children
      will be examined and receive spectacles at the school site.

      Secondary hypothesis: Cost recovery from the Referral + Cost Recovery Model will make this
      more cost-effective than either of the other models.

      Proposed analysis: Cost per child identified needing spectacles, who gets and is still
      wearing them 8 to 12 weeks later, compared between the Referral + Cost Recovery and other
      groups.

      The investigators will also do a stratified analysis comparing the main outcome between
      groups at each of the 3 participating hospitals. Additional stratified analyses/balancing of
      the main outcome between groups will be done for public versus private schools and rural
      versus urban schools.

      The investigators will be using Latent class regression analysis and Finite mixture models to
      analyze the main outcome.

      Monitoring: A dedicated Project Manager, Ms. Priya Reddy, will be responsible for the overall
      planning, implementation, coordination, and monitoring and evaluation in the project. She
      will recruit a local project assistant at each site to coordinate all activities at the
      community level and at the base hospital and Vision Centers; ensure that appropriate planning
      is done for organizing and implementing screening activities; and coordinate availability of
      trained manpower, equipment, and facilities. Ms. Reddy will interact with Orbis India Project
      Managers for the REACH program.

      Research advisors Congdon, Gogate, and Bassett each has decades of familiarity with
      refractive error research in children, and all have engaged in multiple research projects in
      India. Additionally, Congdon has worked with Orbis since 2009 and is now its Director of
      Research.

      Ethical considerations: Ethical approval has been received from two of the partners in India
      and Queen's University Belfast and will be sought from the additional partner. In the two
      Referral model groups, children who need to go to the facility to get spectacles but do not
      do so within the 8 to 12 weeks period will receive free spectacles at closeout, so that no
      child requiring treatment will be left untreated.
    

Intervention name(s): School Model; Referral Model; Referral Model + Cost Recovery
Intervention type(s): Other; Other; Other
Intervention description(s): Free delivery of glasses at the school within two weeks after screening; After the primary screening children referred to nearby Vision Center/ secondary center for refraction and delivery of free glasses.; After the screening children referred to Vision Center for refraction and delivery of free glasses with the option to purchase "upgrade glasses"
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a cluster randomized trial, with eligible children allocated to the intervention that their school (N=141) was randomized to receive. This will be one of the following three:
School Model: 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.
Referral Model: 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.
Referral Model + Cost Recovery: 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". Teachers will contact families not presenting for follow-up care and for spectacle compliance.
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Child; Refractive Error; Myopia; School screening; Cost effectiveness; India