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Healthcare Quality IndicatorsPACHANCT02898090

Development and Validation of Automated Indicators on the Appropriateness of Oral Anticoagulant Prescriptions

An observational study of Healthcare Quality Indicators and Inappropriate Prescribing, run by University Hospital, Bordeaux at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research focuses on the development and validation of indicators on the appropriateness of oral anticoagulant prescriptions. The investigators want to propose transferable tools to other healthcare institutions to allow automated construction of indicators as part of a structured approach to improve future… Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,213 participants
Where
4 sitesFrance
Study dates
28 Apr 2018to 1 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients hospitalized for a clinical situation that could justify a prescription of oral anticoagulants or for an at risk situation in patients under oral anticoagulants, among targeted frequent clinical situations.

Who may be able to join

  • Patients aged over 18;
  • Patients hospitalized at the Bordeaux University Hospital or the Georges-Pompidou European hospital for a clinical situation that could justify a prescription of oral anticoagulants or for an at risk situation in patients under oral anticoagulants, among targeted frequent clinical situations;
  • Patients hospitalized in medicine-surgery-obstetrics care or rehabilitation care (conventional hospitalization or outpatient) between the 1st of January 2015 and the 31th of December 2017;
  • Patients whose medical and administrative data are available in an electronic format in the hospital information system

Who cannot join

  • Patients not hospitalized at the Bordeaux University Hospital or the Georges-Pompidou European hospital for a clinical situation that could justify a prescription of oral anticoagulants or for an at risk situation in patients under oral anticoagulants, among targeted frequent clinical situations;
  • Patients whose medical and administrative data are not available in an electronic format in the hospital information system;
  • Patients who do not give consent for research data use.

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Service d'Information Médicale, Unité d'Informatique et d'Archivistique Médicale (UIAM)

    Bordeaux

  • Université de Lille 3

    Lille

  • Hôpital européen Georges-Pompidou - Département d'informatique Hospitalière

    Paris

  • CHU de Rennes - Service d'information médicale

    Rennes

Other trials in France

About this study

Official title: Development and Validation of Indicators on the Appropriateness of Oral Anticoagulant Prescriptions in Adult Medicine Automated From the Hospital Information System (PACHA Study).

This research focuses on the development and validation of indicators on the appropriateness of oral anticoagulant prescriptions. The investigators want to propose transferable tools to other healthcare institutions to allow automated construction of indicators as part of a structured approach to improve future practices. The main objective of the study is to develop indicators on the appropriateness of oral anticoagulant prescriptions in adult medicine automated from the hospital information system and to assess their criterion validity.

Read the detailed description

The appropriateness of oral anticoagulant prescriptions (Vitamin K Antagonists and Direct Oral Anticoagulants) is a major challenge for improving quality, safety and efficiency of care. The large targeted population, prescription frequency and strong risk of severe adverse events, especially in healthcare institutions, justify the importance of developing indicators on the appropriateness of oral anticoagulant prescriptions and their automated implementation from the hospital information system. There is currently a need to develop and validate such indicators for integrating them into the hospital clinical practice, as part of a structured approach to improve quality and safety of care. As each hospital information system is different, the investigators want to propose transposable tools to other healthcare institutions to allow an automated construction of these indicators.

The study will consist of three main steps: 1) identification of indicators on the appropriateness of oral anticoagulant prescriptions and their conditions of appropriateness (literature review), and analysis of their potential utility and operational characteristic (Delphi consensus); 2) operational implementation of the selected indicators from the hospital information system, using tools to generalize their implementation to other hospital information systems; 3) evaluation of metrological performance and robustness of the selected indicators. This is an observation of prescriptions after it has occurred without any modification or change of treatment to patients. This study is never Interventional.

Statistical analysis : for each indicator, the criterion validity will be analyzed thanks to prevalence of appropriateness (or not) of oral anticoagulant prescriptions estimated by the hospital information system, sensitivity, specificity, positive and negative predictive values, and area under the ROC curve.

Keywords
Quality indicators, Appropriateness, Oral anticoagulant prescriptions, Development and validation, Hospital information system, Information Storage and Retrieval, Natural Language Processing
Medical subject headings
Atrial Fibrillation, Venous Thromboembolism, Heart Valve Diseases, Brain Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference between the prevalence of appropriateness (or not) of oral anticoagulant prescriptions

    Difference between the prevalence of appropriateness (or not) of oral anticoagulant prescriptions estimated by the hospital information system in comparison to the prevalence estimated by the reference test (information manually extracted from the patient record) for each indicator, and the estimation of its confidence interval for an equivalence margin between 5% and 10%.

    Measured: between month 24 and 33

Secondary outcomes (5)

  1. The recall, precision and F-measure of tools tracking information for the construction of indicators (step 2)

    Recall, precision and F-measure are criteria for measuring performance of tools tracking information. The recall is defined by the number of relevant concepts that are correctly found by the evaluated automatic tool compared to the number of relevant concepts that are present in the text (in statistics, the recall is the sensitivity). Precision is the number of relevant concepts found on the total number of concepts proposed by the search engine for a given query. The F-measure combines recall and precision as follows:

    F-measure = 2 x recall x precision / (recall + precision).

    Measured: between month 16 and 18

  2. The ability to use the autonomous version of automatic language processing module (Web-Service)

    to provide the same indicators with another data storage (step 2) : extraction of the concept in full text from the Rennes university hospital (yes or no)

    Measured: between month 30 and 36

  3. The estimation of the metrological performances of each indicator

    sensitivity, specificity, positive and negative predictive values to identify the appropriateness (or not) of oral anticoagulant prescriptions compared to the reference test and opinion of experts with knowledge about the targeted clinical situations (step 3)

    Measured: between month 34 and 36

  4. The estimation of the reliability of each indicator

    Kappa coefficients for unordered qualitative indicators, weighted Kappa coefficients for ordained qualitative indicators and Intra-Class Coefficients for quantitative indicators for the analysis of changes in the appropriateness results of indicators considering variation of the conditions and quality of encoding information in the hospital information system (step 3);

    Measured: between month 34 and 36

  5. The estimation of the robustness of each indicator

    Kappa coefficients for unordered qualitative indicators, weighted Kappa coefficients for ordained qualitative indicators and intra-class coefficients for quantitative indicators for the analysis of changes in the appropriateness results of indicators considering variation of hypotheses for the construction of these indicators (step 3)

    Measured: between month 34 and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study start28 Apr 2018
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02898090
Sponsor's protocol ID
CHUBX 2015/23
Acronym
PACHA
Status last verified
Mar 2024
First submitted
2 Aug 2016
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Petit-Moneger A, Thiessard F, Noize P, Berdai D, Jouhet V, Saillour-Glenisson F, Salmi LR; PACHA research group. Definition of indicators of the appropriateness of oral anticoagulant prescriptions in hospitalized adults: Literature review and consensus (PACHA study). Arch Cardiovasc Dis. 2018 Mar;111(3):155-171. doi: 10.1016/j.acvd.2017.05.005. Epub 2017 Sep 21.

    PubMed 28943263

  • Petit-Moneger A, Thiessard F, Jouhet V, Noize P, Berdai D, Kret M, Sitta R, Salmi LR, Saillour-Glenisson F; PACHA research group. Development and validation of hospital information system-generated indicators of the appropriateness of oral anticoagulant prescriptions in hospitalised adults: the PACHA study protocol. BMJ Open. 2017 Aug 31;7(8):e016488. doi: 10.1136/bmjopen-2017-016488.

    PubMed 28860229

Questions about this trial

What is this clinical trial studying?

An observational study of Healthcare Quality Indicators and Inappropriate Prescribing, run by University Hospital, Bordeaux at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference between the prevalence of appropriateness (or not) of oral anticoagulant prescriptions (time frame: between month 24 and 33). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02898090, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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