Development and Validation of Automated Indicators on the Appropriateness of Oral Anticoagulant Prescriptions (PACHA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02898090|
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : August 1, 2018
|Condition or disease|
|Healthcare Quality Indicators Inappropriate Prescribing Anticoagulant Drugs Atrial Fibrillation Venous Thromboembolism Valvular Heart Disease Brain Injury|
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|
|Estimated Enrollment :||1480 participants|
|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).|
|Actual Study Start Date :||April 28, 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
- 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%.
- 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).
- 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)
- 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)
- 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);
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898090
|Contact: Frantz THIESSARD, MD||(0)5 57 57 45 22 ext +email@example.com|
|Service d'Information Médicale, Unité d'Informatique et d'Archivistique Médicale (UIAM)||Recruiting|
|Contact: Frantz THIESSARD, MD (0)5 57 57 45 22 ext +33 firstname.lastname@example.org|
|Université de Lille 3||Not yet recruiting|
|Contact: Natalia GRABAR, PhD email@example.com|
|Hôpital européen Georges-Pompidou - Département d'informatique Hospitalière||Not yet recruiting|
|Contact: Anita BURGUN, Prof firstname.lastname@example.org|
|CHU de Rennes - Service d'information médicale||Not yet recruiting|
|Contact: Marc CUGGIA, Prof email@example.com|
|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|