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

February 19, 2026 updated by: University Hospital, Bordeaux

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Chu de Bordeaux
      • Bordeaux, France
        • CHU Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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, ...);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
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.
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)
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.
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicator

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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
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
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.
2017-2021 for CCS indicators ; 2019-2021 for post-stroke orientation indicator; 2022-2023 for post-stroke consultation indicator

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: EMILIE LESAINE, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2021/57

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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