Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04800718 |
| Other study ID # |
SCEH/IRB/2020/APR/54 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 22, 2021 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Seva Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
Sample Size: Average OPD attendance at the intervention VCs is 7/day, at present. The
investigators expect to achieve 14 after the intervention, failing which, the intervention
will not be considered a success. Therefore, the primary objective of the statistical
analysis should be to estimate the average attendance, post-intervention, with extreme
precision which leads us to assess if the investigators have been able to achieve the target
(14 per day on average). The investigators set the confidence interval ±1 for the
post-intervention sample mean (the narrowest possible confidence interval in this case). To
check if at least 20 per day on average has been achieved, the investigators expect a sample
mean of at least 21 (i.e. the confidence interval will be 20-22). The investigators assume
that the probability of the confidence interval is 95%, & the daily OPD attendance has a
Poisson distribution. Thus, the investigators expect that the post-intervention daily
attendance has a Poisson distribution with a mean of at least 21. It implies that the
variance of the distribution also equals 21 (or more), & the investigators want to estimate
the mean with a 95% confidence interval of ±1. It requires a minimum sample size of 81 days.
The investigators have used the following formula to calculate the sample size:
Sample Size= 〖1.96〗^2/d^2 x variance of the distribution Where 1.96 is the 97.5 percentile
point of the standard normal distribution, d is the length of the confidence interval (on one
side of the estimate). d=1 & variance=21 give sample size=81. The investigators had put a
target of 20 in the pre-COVID time but due to the pandemic, the investigators have revised
our desired target to 14 per day to consider the intervention a success. The investigators
have persisted with the additional days in the sample size (instead of 58 days for a target
of 14) to be able to estimate up to 14 per day OPD with precision.
Intervention arm: The intervention will include door-to-door screening & awareness generation
in 8-12 villages surrounding the intervention VC. The VC team will be trained in using the
PEEK acuity20 application for measuring visual acuity & using the data collection software
(Taraka) on android platforms. A list of surrounding villages (within 10km) will be prepared
by the Vision Centre Coordinator & the VC attendant. The Vision Centre Coordinator will meet
the village leader to take permission for the door-to-door intervention survey to be carried
out in the village. After having received the necessary permissions, a priority list of
survey villages would be prepared to initiate the intervention. In the intervention villages,
the VC attendant will go from door to door. During the screening, if any house is locked or
family members are not available, the attendant will attempt to contact those missing at
least 3 times. The attendant will explain the intervention & obtain consent for participation
in the survey. Household or family members, who are unwilling or not interested to
participate in the survey, will also be recorded separately. After obtaining consent, the
attendant will communicate regarding the need for eye care in general & share the IEC
material. For each family member above 5 years of age, the visual acuity of each eye will be
taken & recorded using the PEEK application on a smartphone. Demographic data, ocular
complaints & information regarding any previous eye check-up would be also be recorded in the
android application. Any person with a visual acuity <6/12 (cut-off) or other eye issues
would be counseled & referred for a comprehensive examination to the vision center. A
referral slip will be provided to referred patients along with a reason for referral.
Referred patients' records will be available to the Vision Technician (optometrist) through
the software. Patients reporting to the VC for a comprehensive check-up & treatment, due to
the door-to-door intervention will be recorded in the vision center management software
(VCMS). Any patient requiring surgical treatment or further care will be referred to the
respective secondary center.
Control Arm: The control arm VC will continue its routine awareness activities & health talk
sessions in the community. The VC attendant will prepare a monthly activity plan & organize
activities in the surrounding 8-10 villages. Persons with eye issues will be recorded &
referred to the VC for further evaluation & treatment. Patients reporting to the VC will be
registered in the VCMS. For surgical interventions or further care, patients will be referred
to the respective SC. The activities will be the same in both the arms & will also be
standardized in the same manner. Only their mode & reach will be different.
Project Timelines: The study period will be 12 months. Two months will be spent preparing the
study intervention & obtaining approvals, three months will be needed for pre-intervention
work i.e. training the team, field preparation, finalizing a data collection format & IEC
development, four months for the intervention & data collection. After data collection, the
remaining three months will be used for data analysis & writing.
Data Collection & Variables: Both electronic & manual data collection for both arms.
Intervention arm-field level data (door-to-door survey) through software; Control arm-field
level activity in the activity register manually. VC level data would be extracted from the
VCMS, for both control & intervention VCs. In both arms, programmatic data will be collected,
which includes data regarding the villages screened, door-to-door screening, walk-in OPD,
those reporting after referrals from the field, spectacles advised & their uptake, as well as
referral for cataract, specialty & surgical follow-up. Cost data will be collected for
direct, indirect & opportunity costs like rent, human resources, overheads & community
activities. Also, data for revenue from OPD, spectacles & surgery done.
Quality Assurance: Three sources of data: door-to-door screening data will be collected
through the customized android application, data of patients visiting VCs will be captured
through VCMS & additional data pertaining to activities from the control VCs & staff visits
would be collected on the registers. The software has checks & balances ensuring complete
data collection. Manual data collection will be standardized through a checklist. Random
monitoring visits will be made periodically to the field. Data collected during the day will
be uploaded on the cloud server at least once at the end of the day for review. Data quality
will be ensured by clearly defined roles, appropriate resource allocation & regular meetings
with the team members. A regular review process will be followed to ensure quality data
collected & at least 10% of it will be verified by field supervisors. Surgery-related data of
SC referrals would be extracted from the SC EMRs. Data would be collated monthly as a part of
routine program monitoring.
Data Analysis: Collected data would be tabulated & analyzed by arm: distance of village; age;
gender; eye issues; visual acuity; compliance with treatment- medicine, surgery, glasses &
revenue & expenditure of VC. The difference from baseline in the number of walk-in patients,
referrals, uptake of services & costs involved in intervention would be analyzed. Z-test will
be used to compare the change in walk-in patients between the two arms. A P-value of less
than 0.05 would be considered significant.
Cost-Effectiveness Analysis: Cost-effectiveness analysis (CEA) & Incremental CEA will be
performed. The incremental cost for every additional beneficiary attending the VC will be
calculated. To calculate the increase in patients, the average number visiting per day during
the same months last year would be subtracted from the average in the study period. Change in
control VC, if any, would also be deducted before using this as the denominator for
calculation.
