Clinical trial NCT02898090: Development and Validation of Automated Indicators on the Appropriateness of Oral Anticoagulant Prescriptions
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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthcare Quality Indicators
Inappropriate Prescribing
Anticoagulant Drugs
Atrial Fibrillation
Venous Thromboembolism
Valvular Heart Disease
Brain Injury
Keywords: Quality indicators
Appropriateness
Oral anticoagulant prescriptions
Development and validation
Hospital information system
Information Storage and Retrieval
Natural Language Processing
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry for Health and Solidarity, France
First posted: 2016-09-13
Enrollment: 1213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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 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.

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 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 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.

Primary outcomes:
measure: Difference between the prevalence of appropriateness (or not) of oral anticoagulant prescriptions
timeFrame: between month 24 and 33
Secondary outcomes:
measure: The recall, precision and F-measure of tools tracking information for the construction of indicators (step 2)
timeFrame: between month 16 and 18
measure: The ability to use the autonomous version of automatic language processing module (Web-Service)
timeFrame: between month 30 and 36
measure: The estimation of the metrological performances of each indicator
timeFrame: between month 34 and 36
measure: The estimation of the reliability of each indicator
timeFrame: between month 34 and 36
measure: The estimation of the robustness of each indicator
timeFrame: between month 34 and 36
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service d'Information Médicale, Unité d'Informatique et d'Archivistique Médicale (UIAM)
city: Lille
country: France
facility: Université de Lille 3
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou - Département d'informatique Hospitalière
city: Rennes
country: France
facility: CHU de Rennes - Service d'information médicale
Study officials:
affiliation: University Hospital Bordeaux, France
name: Aurélie PETIT-MONEGER, MD
role: STUDY_CHAIR
affiliation: University Hospital Bordeaux, France
name: Florence SAILLOUR-GLENISSON, MD
role: STUDY_CHAIR
affiliation: University Hospital Bordeaux, France
name: Frantz THIESSARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.