Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800718
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2021-03-10
Brief Title:
Increasing Vision Center Service Utilization
Sponsor:
Seva Foundation
Organization:
Seva Foundation
Study Overview
Official Title:
Effect of Door-to-door Screening and Awareness Generation Activities in the Catchment Areas of Vision Centers on Service Utilization a Randomized Experimental Intervention
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Shroffs Charity Eye Hospital is planning an intervention door-to-door screening in VCs 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 ie 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
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 ie 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
Detailed 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 50000 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 years 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 inclusionexclusion 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
InclusionExclusion 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 10day 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 25 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 70000 On the other hand Raya block has 124 villages with 90 within 10km of the VC having a combined population of 130000 In Kheri the Mitauli block has 138 villages with 75 within 10km of the VC The combined population is around 111000 Pashgaon block has 230 villages with 85 within 10km of the VC a population of around 110000
Sample Size Average OPD attendance at the intervention VCs is 7day 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 ie 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 1962d2 x variance of the distribution Where 196 is the 975 percentile point of the standard normal distribution d is the length of the confidence interval on one side of the estimate d1 variance21 give sample size81 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 612 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 ie 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 005 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
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 years 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 inclusionexclusion 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
InclusionExclusion 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 10day 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 25 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 70000 On the other hand Raya block has 124 villages with 90 within 10km of the VC having a combined population of 130000 In Kheri the Mitauli block has 138 villages with 75 within 10km of the VC The combined population is around 111000 Pashgaon block has 230 villages with 85 within 10km of the VC a population of around 110000
Sample Size Average OPD attendance at the intervention VCs is 7day 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 ie 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 1962d2 x variance of the distribution Where 196 is the 975 percentile point of the standard normal distribution d is the length of the confidence interval on one side of the estimate d1 variance21 give sample size81 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 612 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 ie 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None