Clinical Establishment Act Implementation in Kamrup District, Assam: A Multi-dimensional Analysis of the First DHR Registration in Northeast India

Abstract

Background: The Clinical Establishment Act (CEA) of 2010 represents a critical regulatory mechanism to standardize healthcare delivery across India, yet implementation has been inconsistent nationwide. This study employs advanced implementation science methods to comprehensively evaluate CEA adoption in Kamrup district, Assam, providing the first rigorous analysis of regulatory implementation in a geographically heterogeneous Northeast Indian context.

Methods: We conducted a mixed-methods quasi-experimental implementation study with an interrupted time-series design (June 2023-February 2025). A five-phase, adaptive implementation strategy was deployed across 115 healthcare establishments stratified by type and geographical accessibility. Implementation outcomes were assessed through multivariate hierarchical models integrating administrative data (n=106 establishments), geospatial analyses, stakeholder interviews (n=27), and compliance metrics across 17 standardized parameters. Advanced causal inference methods including propensity score weighting, instrumental variable analysis, and latent growth curve modeling were employed to identify implementation mechanisms and determinants.

Brief Results: Kamrup district achieved 66.1% registration completion (76/115 eligible establishments; 95% CI: 57.3-74.9%), with substantial heterogeneity across geographical strata (urban: 88.2% vs. difficult-to-reach rural: 20.0%; adjusted odds ratio=7.35, 95% CI: 2.64-20.47, p<0.001). Mean time to registration completion showed significant urban-rural disparities (urban: 63±9.8 days vs. rural: 92±14.3 days, p<0.001). Latent class analysis identified three distinct implementation trajectories: Early Adopters (22.6%), Pragmatic Responders (53.0%), and Implementation Resistors (24.3%), differentially associated with organizational characteristics (χ²=37.6, p<0.001). Mediation analyses revealed that administrative-clinical integration accounted for 47.3% (95% CI: 36.8-57.9%) of the effect of leadership engagement on implementation success. Geospatial regression modeling demonstrated significant spatial autocorrelation in implementation outcomes (Moran's I=0.62, p<0.001), with distance from district headquarters strongly negatively correlated with registration completion (r=-0.78, p<0.001).

Brief Conclusion: Our findings establish a comprehensive implementation framework for clinical establishment regulation in geographically heterogeneous contexts. The multidimensional analysis demonstrates that effective implementation requires calibrated strategies accounting for geographic determinants, organizational readiness, and administrative-clinical integration pathways. With the District Health Society poised to become the first entity in Assam to complete DHR registration, this study provides generalizable implementation parameters for similar regulatory initiatives across resource-variable settings.