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

NCT02898090 | Completed

• 1 other identifier: CHUBX 2015/23
• Study Type: observational
• Target: 1,213
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (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%.

  between month 24 and 33

Secondary Outcomes (5)

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

  between month 16 and 18

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

  between month 30 and 36

• The estimation of the metrological performances of each indicator

  between month 34 and 36

• The estimation of the reliability of each indicator

  between month 34 and 36

• The estimation of the robustness of each indicator

  between month 34 and 36

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry for Health and Solidarity, France: collaborator

Study Sites (4)

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

Bordeaux, France

Location

Université de Lille 3

Lille, France

Location

Hôpital européen Georges-Pompidou - Département d'informatique Hospitalière

Paris, France

Location

CHU de Rennes - Service d'information médicale

Rennes, France

Location

Related Publications (2)

• 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.

  PMID: 28943263 RESULT

• 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.

  PMID: 28860229 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism; Heart Valve Diseases; Brain Injuries

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Aurélie PETIT-MONEGER, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

• Florence SAILLOUR-GLENISSON, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

• Frantz THIESSARD, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: September 13, 2016
• Study Start: April 28, 2018
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)