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Completed

NCT Number: NCT07428382

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Bordeaux, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

acute phase stroke cohort:

  • 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

Inclusion criteria

post-stroke consultation cohort:

  • 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,

Exclusion criteria

post-stroke consultation cohort:

  • 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, ...);

Treatment and study plan

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.

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

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

    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).

Secondary outcomes

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

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

    This 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.

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

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

    This 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.

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

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

    Acceptability will be assessed by evaluating the usability and interpretability of indicator results when displayed for institutional and regulatory reporting purposes

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

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

    This 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: DELIQUA-CNV

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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