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Development and Validation of Care Pathway Quality Indicators for Stroke and Chronic Coronary Syndrome Using French Administrative Healthcare Database (DELIQUA-CNV)

Development and Validation of Quality Indicators for the Care Pathways of Patients With Stroke and Chronic Coronary Syndrome: Using Practice Registers as Tools for Validating Algorithms Developed From French National Healthcare Databases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07428382
Acronym
DELIQUA-CNV
Enrollment
36250
Registered
2026-02-23
Start date
2023-07-20
Completion date
2025-12-31
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Coronary Syndrome, Quality Indicators for Healthcare Pathway, Stroke

Keywords

Quality indicators for healthcare pathway, Stroke, Chronic Coronary Syndrome, Validation, French National Healthcare Data System, Practices registries

Brief summary

Cardio-neurovascular diseases are common and costly conditions with care pathways that require optimization. This project aims to develop quality indicators from the French national healthcare database, that are easily deployable and measurable at the national level to improve patient care pathways for both stroke and Chronic Coronary Syndrome

Detailed description

As part of the reform of the French healthcare system, financing models will be adjusted to better account for the quality, safety, and relevance of care, promote coordination among healthcare providers, and establish standardized care pathways. To this end, quality indicators for care pathways are expected for ten priority chronic conditions, including Chronic Coronary Syndromes (CCS) and stroke. These indicators will play a central role in the evaluation of the new quality-based financing system, which focuses on patient care pathways. The DELIQUA-CNV project aims to develop and validate four quality indicators for CCS and stroke care pathways based on data from the French National Health Data System (SNDS). Readmission following percutaneous coronary intervention (PCI) represents a significant source of healthcare costs and serves as a key indicator of care quality. While readmissions for planned PCI, often driven by activity-based costing models, raise concerns regarding their relevance, they also contribute to increased patient risks and higher healthcare expenses. On the other hand, emergency readmissions after an outpatient procedure serve as a crucial safety indicator for ambulatory care practices. As such, the two key indicators for the CCS care pathway are: 1) Readmission for a new scheduled PCI following an initial PCI for CCS (Sched Re-PCI), and 2) Readmission for a new emergency PCI or coronary angiography following an ambulatory PCI for CCS (Outp Emerg Re-PCI). The post-stroke phase is crucial, as challenges in referring patients to appropriate rehabilitation facilities often results in gaps and disparities in access to care. These gaps disrupt the continuity of the care pathway. Multi-professional post-stroke consultations are essential for assessing consequences of the stroke and ensuring the delivery of appropriate care. Therefore, the selected indicators for the stroke care pathway are intended to strengthen the organization and quality of care during the post-acute phase: 3) Post-hospitalization orientation during the acute phase according to stroke severity (Stroke\_Orient), 4) Identification of multidisciplinary post-stroke consultations between 2 and 6 months after the acute phase (Post-stroke\_Cnslt). To develop these indicators, three population-based cohorts for each care pathway will be derived from cardio-neurovascular registers in Nouvelle-Aquitaine region. The first cohort will be obtained from the interventional cardiology registry for (ACIRA) covering the period from 2017 to 2021. The second cohort will be based on the Aquitaine Observatory of Stroke - Acute phase module (OBA2) for the years 2019 to 2021. The third cohort will focus on post-stroke consultation between July 2022 and December 2023 extraced from OBA2 - Post consulation module. These cohorts will be linked to data from the SNDS, utilizing an indirect deterministic matching approach. These linked databases will serve as the primary reference for validating the quality indicators. These validated indicators will subsequently play a key role in refining care practices and advancing the implementation of quality-based financing models within the healthcare system.

Interventions

OTHERNo intervention (data matching only)

These cohorts were linked to data from the SNDS, utilizing an indirect deterministic matching approach. These linked databases serve as the primary reference for validating the quality indicators.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

cohort Chronic Coronary Syndromes (CSS) * Patient being over 18 years of age living in metropolitan France; * Patients underwent coronary angiography or PCI between January 2017 and December 2021 for an indication of CCS (stable angina, silent ischemia, other ischemia) at one of the 11 interventional cardiology centers in Aquitaine;

Exclusion criteria

cohort Chronic Coronary Syndromes (CSS) * Patients refused to participate in the ACIRA registry (The ACIRA registry is an on-going, multicenter, prospective, exhaustive cohort study of patients who undergo coronary angiography or PCI in eleven interventional cardiology centers in the french Aquitaine region); * Patients who died during the index hospitalization * Patients with ACIRA stays not matched with SNDS data Inclusion Criteria acute phase stroke cohort: * Patient being over 18 years of age living in metropolitan France; * Patients treated between January 2019 and December 2021 for a recent stroke (less than 15 days) with clear onset (sudden onset, focal nature of the neurological deficit, confirmation by brain imaging - CT scan or MRI - showing a vascular origin, either ischemic or hemorrhagic, consistent with the clinical presentation) at one of the 16 healthcare facilities in Nouvelle-Aquitaine that treat more than 30 strokes per year.

Design outcomes

Primary

MeasureTime frameDescription
Criterion validity - sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of SNDS-based quality indicators for Chronic Coronary Syndrome and Stroke care pathways2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicatorThe calculation and performance of quality indicators derived from SNDS will be assessed by comparison with practice registries, which will be used as the gold standard. Indicator performance will be quantified using sensitivity, specificity, PPV, and NPV. The evaluated SNDS-based quality indicators include: * Readmission for a new scheduled PCI following an initial PCI for CCS (Sched Re-PCI). * Readmission for a new emergency PCI or coronary angiography following an ambulatory PCI for CCS (Outp Emerg Re-PCI). * Immediate post-hospital rehabilitation pathway after stroke, in accordance with the orientation criteria recommended by the French National Authority for Health (HAS) in 2020 (Post-stroke\_Orient). * Identification of multidisciplinary post-stroke consultations between 2 and 6 months after the acute phase (Post-stroke\_Cnslt).

Secondary

MeasureTime frameDescription
Construct validity - statistical associations between SNDS-based quality indicators and external indicators of care processes for CCS and stroke2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicatorThis outcome measure evaluates the construct validity of SNDS-based quality indicators by assessing their statistical associations with external indicators reflecting similar care processes, when available. Construct validity will be quantified using correlation coefficients and comparative statistical analyses between SNDS-based indicators and external reference indicators.
Discriminatory validity - geographic variation in SNDS-based quality indicator values for Chronic Coronary Syndrome and Stroke care pathways2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicatorThis outcome measure evaluates the ability of SNDS-based quality indicators to discriminate across geographic areas by analyzing variation in indicator values between healthcare facilities. Variation will be assessed using funnel plots and league tables, and results will be reported at the facility level.
Acceptability - usability and interpretability of SNDS-based quality indicators for institutional reporting2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicatorAcceptability will be assessed by evaluating the usability and interpretability of indicator results when displayed for institutional and regulatory reporting purposes
Sensitivity to change - temporal trends in SNDS-based quality indicator values for Chronic Coronary Syndrome and Stroke care pathways2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicatorThis outcome measure evaluates the ability of SNDS-based quality indicators to detect change over time by analyzing temporal trends in indicator values across the study period. Changes over time will be assessed using statistical modeling methods to estimate trends and identify significant variations in indicator values.

Countries

France

Contacts

PRINCIPAL_INVESTIGATOREMILIE LESAINE

University Hospital, Bordeaux

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026