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

March 26, 2024 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1213

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
        • Service d'Information Médicale, Unité d'Informatique et d'Archivistique Médicale (UIAM)
      • Lille, France
        • Université de Lille 3
      • Paris, France
        • Hôpital européen Georges-Pompidou - Département d'informatique Hospitalière
      • Rennes, France
        • CHU de Rennes - Service d'information médicale

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between the prevalence of appropriateness (or not) of oral anticoagulant prescriptions
Time Frame: between month 24 and 33
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%.
between month 24 and 33

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recall, precision and F-measure of tools tracking information for the construction of indicators (step 2)
Time Frame: between month 16 and 18

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).
between month 16 and 18
The ability to use the autonomous version of automatic language processing module (Web-Service)
Time Frame: between month 30 and 36
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)
between month 30 and 36
The estimation of the metrological performances of each indicator
Time Frame: between month 34 and 36
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)
between month 34 and 36
The estimation of the reliability of each indicator
Time Frame: between month 34 and 36
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);
between month 34 and 36
The estimation of the robustness of each indicator
Time Frame: between month 34 and 36
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)
between month 34 and 36

Collaborators and Investigators

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

Sponsor

University Hospital, Bordeaux

Collaborators

Ministry for Health and Solidarity, France

Investigators

  • Study Chair: Aurélie PETIT-MONEGER, MD, University Hospital Bordeaux, France
  • Study Chair: Florence SAILLOUR-GLENISSON, MD, University Hospital Bordeaux, France
  • Principal Investigator: Frantz THIESSARD, MD, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 28, 2018

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimated)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2015/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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