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临床试验/NCT07513402
NCT07513402尚未招募不适用

Facility-Level Determinants of Post-Operative Cataract Follow-Up Compliance: A Phased Mixed-Methods Implementation Study of Vision Center-Based Follow-Up Systems in Rural and Semi-Rural India.

Seva Canada Society0 个研究点目标入组 150 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
主要终点
Post-operative follow-up compliance

研究概览

简要总结

Cataract remains the leading cause of avoidable blindness in India despite substantial expansion of surgical services over the past two decades. While surgical coverage has improved, optimal visual outcomes depend on effective post-operative follow-up, which remains inconsistent across decentralized Vision Center-based systems, particularly in rural and semi-urban settings. Routine program data show wide variation in post-operative cataract follow-up compliance among Vision Centers operating within similar organizational and geographic contexts, suggesting the influence of facility-level determinants.

This phased mixed-methods implementation study aims to identify facility-level factors influencing post-operative cataract follow-up compliance and to develop an evidence-based framework to strengthen follow-up systems. Phase 1 will involve retrospective analysis of three years of integrated Health Management Information System- Vision Centre Management Information System (HMIS-VCMIS) data from approximately 120 Vision Centers to establish empirical benchmarks and classify centers as high- or low-performing. Structured facility assessments and qualitative interviews with Vision Center staff, program managers, and post-operative patients will be conducted to identify operational practices, workflows, and contextual factors associated with follow-up performance.

Phase 2 will focus on co-design, pilot testing, and early implementation of a Follow-Up Strengthening Intervention Framework in selected low-performing Vision Centers. The intervention will include standardized counselling workflows, follow-up tracking and reminder systems, role clarification, supervisory feedback mechanisms, and peer-learning support from high-performing centers. Changes in follow-up compliance will be monitored using routine data over a 12-month implementation period, alongside process evaluation to assess feasibility, fidelity, and acceptability.

Findings from this study will generate practical evidence to strengthen post-operative cataract follow-up systems and inform scalable quality improvement strategies within decentralized Vision Center networks.

详细描述

Cataract remains the leading cause of avoidable blindness in India, accounting for nearly two-thirds of blindness among adults aged 50 years and older. Over the past two decades, the expansion of cataract surgical services through public-private partnerships, outreach programs, and high-volume surgical models has significantly improved surgical coverage and access to care. However, increasing surgical coverage alone is insufficient to ensure optimal visual outcomes unless it is supported by effective post-operative follow-up care.

Post-operative cataract follow-up is a complex service delivery function that requires coordinated action between surgical hospitals, Vision Centers, and community-based systems. It is essential for early detection and management of complications, monitoring visual recovery, providing refractive correction, reinforcing post-surgical counselling, and accurately assessing surgical outcomes. Poor follow-up compliance can result in avoidable visual impairment, delayed treatment of complications, reduced patient satisfaction, and inaccurate assessment of surgical quality, thereby undermining the overall effectiveness of cataract programs.

Vision Centers (VCs) serve as decentralized eye care facilities providing continuity of care following cataract surgery, particularly in rural and semi-urban settings. By reducing travel distance, direct costs, and opportunity losses for patients, Vision Centers are intended to facilitate timely post-operative follow-up closer to patients' homes. Although often categorized as primary eye care facilities, in the context of cataract services they function as task-shifted platforms for post-operative follow-up and referral, linking secondary surgical care with community-level access.

Despite this decentralized model, routine program data indicate wide variation in post-operative follow-up compliance across Vision Centers. Some centers consistently achieve compliance rates exceeding 80%, while others remain below 60%, even within similar organizational, geographic, and programmatic contexts. This variability suggests that follow-up compliance is influenced not only by patient-level factors but also by facility-level and system-level determinants, including staffing patterns, counselling workflows, follow-up tracking mechanisms, documentation practices, community engagement strategies, and managerial or sponsor support. These facility-level determinants have not yet been systematically examined using an implementation-focused and evidence-based approach.

Definition of High- and Low-Performing Vision Centers

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥40 years
  • All cataract surgery types (e.g., SICS, phacoemulsification)
  • Advised Vision Center follow-up at discharge
  • Complete HMIS-VCMIS linkage

排除标准

  • Age <40 years
  • Non-cataract surgeries
  • No advised Vision Center follow-up

研究组 & 干预措施

Compliance Improvement arm

Experimental

干预措施: Follow-Up Strengthening Intervention Framework (Other)

结局指标

主要结局

Post-operative follow-up compliance

时间窗: 12 months

The primary outcome will be defined as facility-level postoperative follow-up compliance, calculated as the proportion of cataract patients who complete at least one follow-up visit at a Vision Center within 1 month (±15 days) of surgery. The denominator will include patients advised to follow up with the Vision Center at discharge, and the numerator will include those who completed the follow-up within this time window. The outcome will be based on HMIS-VCMIS linked patient records and analyzed at the Vision Center level over a 12-month observation period.

次要结局

未报告次要终点

研究者

发起方
Seva Canada Society
申办方类型
Other
责任方
Sponsor

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