- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547527
Evaluating the Integration Model of a Standalone Eye Centre Into Provincial Government Hospital
Evaluating the Integration Model of a Standalone Eye Centre Into Provincial Government Hospital: A Case Study From Kalaiya, Bara District, Nepal
This study aims to evaluate the integration of a standalone eye centre into the Provincial Government Hospital in Kalaiya, Bara District, Nepal. The integration model seeks to improve access to comprehensive eye care services by combining the specialized expertise of an eye care facility with the infrastructure and patient flow of a provincial hospital. As the burden of avoidable visual impairment remains high in Nepal, strengthening service delivery at the district level has the potential to improve early detection, timely treatment, and continuity of care. 1 A mixed-method approach will be used to assess changes in service utilization patterns for example patient volume, follow ups and referrals following the integration. Additional focus will be placed on the acceptability of the integration model among patients, eye care professionals, and the hospital staff. This study will help to generate evidence-based recommendations to guide district-level planning for integrated eye care models by 2027.
Data will be collected from patient records, hospital statistics, patient and staff interviews. The findings are expected to provide evidence on the feasibility, challenges, and benefits of integrating specialized eye care units into provincial hospital systems in low-resource settings. Ultimately, the study aims to inform policy decisions, support scalable models of eye care integration, and contribute to improved eye health outcomes for underserved populations.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Worldwide there are 36.0 million blind and 216.6 million visually impaired. Of these, the majority of cases are preventable or treatable. With most eye care being delivered through secondary and tertiary levels of the health system, initial access to services remains a barrier to addressing visual impairment. A key approach to improving access is the integration of eye care into primary health care to provide treatment and referral at the lowest population level to identify those in need of eye health services.2 Visual impairment remains a significant public health concern in Nepal, particularly in rural and peri-urban regions where access to specialized eye care is limited. District-level hospitals represent the primary point of care for substantial segments of the population; however, these facilities frequently lack the ophthalmic infrastructure, skilled personnel, and diagnostic capacity required to address the growing burden of ocular morbidity. Standalone eye centers, often operated by non-governmental or semi-autonomous entities, have historically supplemented government services and played a critical role in delivering specialized ophthalmic care. Despite their strengths, these centers commonly function in parallel to the public health system, resulting in fragmented service delivery, inconsistent referral pathways, and challenges in long-term care coordination.3 This study aims to undertake a comprehensive academic evaluation of the integration of a standalone eye centre into the Provincial Government Hospital in Kalaiya, Bara District, Nepal. The initiative seeks to merge the specialized clinical capabilities and equipment resources of the Kalaiya Eye Centre (KEC) with the infrastructural capacity, patient volume, and administrative governance of the Provincial Government Hospital. This type of integration model represents an innovative approach to strengthening district-level eye care by enhancing system cohesion and optimizing resource utilization. Rigorous assessment of this model is necessary to determine its feasibility, operational efficiency, scalability, and potential contribution to strengthening Nepal's eye health system.4 The primary objectives of the study are to Compare patient service utilization (outpatient visits, follow ups, referrals) before and after integration. Secondary objectives include, to assess patient and community perceptions of accessibility, convenience, and quality of eye care services following integration.
A mixed-method research design will be employed to enable a holistic understanding of the integration process. Quantitative data will be extracted from electronic and paper-based service statistics, hospital records, and patient registries. This dataset will include indicators such as patient volume, follow ups and referrals. Statistical analyses will be undertaken to compare pre-integration and post-integration performance across these parameters, with the aim of identifying measurable improvements or persistent gaps.
Qualitative data will be obtained through semi-structured interviews, focus group discussions, and direct observational assessments involving ophthalmologists, optometrists, administrative personnel, and patients. The qualitative component will enable an in-depth examination of staff perceptions, workflow adaptations, communication pathways, patient experiences, and broader contextual factors influencing the success of the integration.
The integration will be examined not only in terms of structural reorganization but also as a dynamic process requiring alignment of institutional cultures, adaptation of workflows, and development of collaborative mechanisms. This perspective is critical for understanding integration as a multifaceted intervention that extends beyond infrastructural consolidation and entails significant organizational transformation.
The expected outcomes of the study include evidence on the extent to which integration improves patient access to timely ophthalmic evaluations, reduces unnecessary delays, and strengthens continuity of care.
This evaluation aligns with Nepal's broader commitments to Universal Eye Health and the national objective of reducing avoidable blindness. Strengthening eye care at the district level is central to achieving equitable service distribution and ensuring that underserved and marginalized populations receive timely, high-quality ophthalmic care. Findings from this study have the potential to inform policy decisions, guide health system strengthening efforts, and contribute to the development of evidence-based models for integrating specialized eye services into public hospital settings.
By providing a rigorous academic assessment of the integration model at Kalaiya, this study aims to contribute to the global discourse on health system integration and collaborative service delivery in low- and middle-income countries. The results are expected to offer transferable insights relevant to other regions seeking to harmonize parallel service structures, improve care coordination, and build more resilient and efficient eye health systems.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All individuals receiving eye-care services at the Kalaiya Eye Centre before and after integration.
- Patients from Bara district and catchment areas
- Patients attending eye services during study period
- New and follow-up patients
Exclusion Criteria:
- Patients outside catchment area (e.g., non-Nepalese)
- Incomplete or missing records
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Post-Integration Group
Patients receiving services after integration into provincial hospital.
|
Patients receiving services after integration into provincial hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Primary Outcome Measure: Change in patient service utilization • OPD visits • Follow-up visits • Referrals
Time Frame: 6 months pre-integration vs 6 months post-integration
|
6 months pre-integration vs 6 months post-integration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in patient perception of accessibility and quality of services
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEH-DGH-INT-2025-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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