Using real-world data to study the efficiency and effectiveness of care for patients with diabetes: CONCEPT-DIABETES study PROTOCOL
Creators: name: Enguita-Germán, Mónica
name: Oscoz-Villanueva, Ignacio
name: Ballesteros-Domínguez, Asier
name: Tamayo-Rodríguez, Ibai
name: Librero-López, Julián
name: Estupiñán-Romero, Francisco
name: Bernal-Delgado, Enrique
name: Ibáñez  Beroiz, Berta
Publisher: name: Zenodo
Year: 2024
Subjects: subject: Protocol
subject: Health care services
subject: Health care pathways
subject: Population-based cohort
subject: Type 2 Diabetes
subject: Process Mining
subject: Clinical Practice Guidelines
subject: Comparative Effectiveness
subject: Federated infraestructure

description: ABSTRACT of CONCEPT-DIABETES STUDY PROTOCOL 

CONCEPT-DIABETES is part of CONCEPT, a coordinated research initiative of five projects that aims at analyzing chronic care effectiveness and efficiency of care pathways in diabetes, congestive health failure, breast cancer and stroke. This project arose under the umbrella of REDISSEC (Research Network on Health Services and Chronicity) and continue functioning under RICAPPS (Research Network on Chronicity, Primary Care and Health Promotion). As common denominator, CONCEPT assumes the relevance of care pathways as independent factors of health outcomes using data from real life world (RWD) from eight Spanish Regional Health Systems.

In the specific case of CONCEPT-DIABETES, the focus is on assessing the effectiveness of a set of clinical practice actions and quality improvement strategies at different levels (patient-level, health-care provider level and health system level) on the process and health outcomes of patients with type 2 diabetes (T2D) using process mining methodology. It is a population-based retrospective observational study, centered on all T2D patients diagnosed in five Regional Health Services within the Spanish National Health Service, that will assess to what extent clinical practice guidelines (CPG) are being implemented in real life and which are their effects, including information from all the patients’ contacts with the health services using the electronic medical record systems of Primary Care data, Specialist Care data, Hospitalizations, Urgent Care data, Pharmacy Claims, and also other registers such as the mortality and the population register. As part of CONCEPT, the methodological approach includes:  a) the analysis of the pathways of the patients; b) cost analyses and efficiency of pathways and interventions; c) methodology development to integrate pathways to construct prediction models and d) methodology development to create decentralized infrastructure built on RWD.

To achieve this aims, we will apply process discovery to identify and characterize the longitudinal trajectories experienced by patients with T2D across the healthcare system and will compare, by conformance checking, those trajectories with theoretical trajectories derived from CPGs in terms of process indicators and pharmacological treatment recommendations. Second, we will estimate the impact of these trajectories on diabetes related complications using traditional and new analytical process mining methods. Finally, we will evaluate the effectiveness and economic impact of the implemented strategies in diabetes control in relation to process and outcome indicators.