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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified September 2016 by University Hospital, Bordeaux
Sponsor:
Collaborator:
Ministry for Health and Solidarity, France
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT02898090
First received: August 2, 2016
Last updated: September 7, 2016
Last verified: September 2016
  Purpose
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.

Condition
Healthcare Quality Indicators Inappropriate Prescribing Anticoagulant Drugs Atrial Fibrillation Venous Thromboembolism Valvular Heart Disease Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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).

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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%.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 1480
Study Start Date: September 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

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 2015;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02898090

Contacts
Contact: Frantz THIESSARD, MD (0)5 57 57 45 22 ext +33 frantz.thiessard@chu-bordeaux.fr

Locations
France
Service d'Information Médicale, Unité d'Informatique et d'Archivistique Médicale (UIAM) Not yet recruiting
Bordeaux, France
Contact: Frantz THIESSARD, MD    (0)5 57 57 45 22 ext +33    frantz.thiessard@chu-bordeaux.fr   
Université de Lille 3 Not yet recruiting
Lille, France
Contact: Natalia GRABAR, PhD       natalia.grabar@univ-lille3.fr   
Hôpital européen Georges-Pompidou - Département d'informatique Hospitalière Not yet recruiting
Paris, France
Contact: Anita BURGUN, Prof       anita.burgun@egp.aphp.fr   
CHU de Rennes - Service d'information médicale Not yet recruiting
Rennes, France
Contact: Marc CUGGIA, Prof       marc.cuggia@univ-rennes1.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
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
  More Information

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02898090     History of Changes
Other Study ID Numbers: CHUBX 2015/23
Study First Received: August 2, 2016
Last Updated: September 7, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Bordeaux:
Quality indicators
Appropriateness
Oral anticoagulant prescriptions
Development and validation
Hospital information system
Information Storage and Retrieval
Natural Language Processing

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Diseases
Brain Injuries
Thromboembolism
Venous Thromboembolism
Heart Valve Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Embolism and Thrombosis
Vascular Diseases
Anticoagulants

ClinicalTrials.gov processed this record on September 21, 2017