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

NCT07428382 | Completed

• 1 other identifier: CHUBX 2021/57
• Study Type: observational
• Target: 36,250
• Locations: 1 country
• Sites: 2

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

Conditions

Quality Indicators for Healthcare Pathway; Stroke; Chronic Coronary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 pathways

  The 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).

  2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicator

Secondary Outcomes (4)

• Construct validity - statistical associations between SNDS-based quality indicators and external indicators of care processes for CCS and stroke

  2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicator

• Discriminatory validity - geographic variation in SNDS-based quality indicator values for Chronic Coronary Syndrome and Stroke care pathways

  2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicator

• Acceptability - usability and interpretability of SNDS-based quality indicators for institutional reporting

  2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicator

• Sensitivity to change - temporal trends in SNDS-based quality indicator values for Chronic Coronary Syndrome and Stroke care pathways

  2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicator

Study Arms (3)

CCS Cohort (January 2017- December 2021)

Adult patients (≥18 years) living in metropolitan France who underwent a percutaneous coronary intervention (PCI) between January 2017 and December 2021 for an indication of chronic coronary syndrome (stable angina, silent ischemia, or other ischemia) in one of the eleven interventional cardiology centers in the Aquitaine region. Detailed inclusion and exclusion criteria for each cohort are provided in the Eligibility Criteria section below.

Other: No intervention (data matching only)

Post-stroke orientation cohort (January 2019- December 2021)

Adult patients (≥18 years) living in metropolitan France who were treated between January 2019 and December 2021 for an acute ischemic or hemorrhagic stroke with a clearly defined onset (within 15 days), confirmed by brain imaging (CT scan or MRI), were included. Patients were managed in one of the eighteen healthcare facilities participating in the Nouvelle-Aquitaine Stroke Observatory (ObA2). Detailed inclusion and exclusion criteria for each cohort are provided in the Eligibility Criteria section below.

Other: No intervention (data matching only)

Post-stroke consultation cohort cohort (July 2022- December 2023)

Adult patients (≥18 years) living in metropolitan France who underwent a multidisciplinary post-stroke consultation between July 2022 and December 2023 following a completed ischemic or hemorrhagic stroke confirmed by brain imaging (CT scan or MRI), within one year after the acute episode, were included. Patients were managed in one of the nineteen healthcare facilities participating in the Nouvelle-Aquitaine Stroke Observatory (ObA2). Detailed inclusion and exclusion criteria for each cohort are provided in the Eligibility Criteria section below.

Other: No intervention (data matching only)

Interventions

No intervention (data matching only) OTHER

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.

CCS Cohort (January 2017- December 2021); Post-stroke consultation cohort cohort (July 2022- December 2023); Post-stroke orientation cohort (January 2019- December 2021)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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;

You may not qualify if:

• 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
• 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.
• Patients refused to participate in the Aquitaine Observatory of stroke of patients diagnosed with a confirmed ischemic or hemorrhagic stroke (OBA2 registry - Acute phase module)
• Patients treated for rehabilitation of sequelae or complications of a recent stroke (less than 15 days), transient ischemic attack (TIA), or any other neurological condition (meningeal hemorrhage, traumatic intracranial hemorrhage, brain tumor, etc.)
• Patients who died during the index hospitalization
• Patients transferred to another facility not participating in ObA2
• Patients with ObA2 stays not matched with SNDS data
• Patient being over 18 years of age living in metropolitan France;
• Patients who benefited from post-stroke consultation between July 2022 and December 2023 following a recent completed stroke (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) within one year after the acute episode,
• Patients refused to participate in the OBA2 registry registry (The Aquitaine Observatory of stroke of patients diagnosed with a confirmed ischemic or hemorrhagic stroke - Multidisciplinary post-stroke consultation) (OBA2 registry - Post-consulation module)
• Patients treated for rehabilitation of sequelae or complications of a recent stroke (less than 15 days), transient ischemic attack (TIA), or any other neurological condition (meningeal hemorrhage, traumatic intracranial hemorrhage, brain tumor, ...);

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

Chu de Bordeaux

Bordeaux, 33000, France

Location

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• EMILIE LESAINE

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: February 23, 2026
• Study Start: July 20, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

FR (2)