Activity and Quality of Care Indicators' for a Sentinel Network Creation

Gynecology Clinical Trial

— URGO  

Official title:

Gynaecological Emergencies: Validation of Indicators of Activity and Quality of Care for Creation of a Network Sentinel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274441
• Other study ID #: NI12027
• Status: Completed
• Phase: N/A
• First received: October 8, 2014
• Last updated: March 1, 2018
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: February 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is no large-scale data in France or internationally, on the quality of care in gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or on determinants of these delays or misdiagnosis. The creation of a sentinel network for gynecological emergencies could help quantify these links and test strategies to avoid the worst effects by implementing simple diagnostic tools from clinical research.

The network will be designed to promote research in women's health and the emergency reception by focusing on:

(i) Assessment of the quality and organization of care and professional practice for the management of gynecological emergencies.

(ii) The study of severe morbidity and its determinants (iii) comparison of organizational practices and health outcomes of women over time within the same department or between services having substantially the same recruitment (iv) Comparison of organization systems gynecological emergencies departement between different high resource francophone countries (France, Switzerland, Belgium).

(v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic derived from clinical research.

Description:

Objectives :

• To measure the incidence of the potentially life-threatening gynaecological emergencies (G-PLE) and of the Cases of severe morbidity (SM)

• To analyze the determinants of the SM,

• To validate an objective score of quality

Criterias of evaluation:

• Incidence of the G-PLE and SM cases during one month.

• Reliability and validity of measurements of the indicators of quality of care.

Methodology:

Stage 1: Data acquisition (prospective) within 22 gynaecological emergencies departments.

Stage 2: Sampling and checking of files of patients included at stage 1

Calendar of the research project:

18 months:

• 6 months for the phase of preparation,

• 1 month for the investigation of incidence,

• 5 months for the phase of checking data,

• 6 months of statistical analysis

Statistical Analyzes:

Descriptive statistics of the data. Estimation of the incidence rate of the potentially life-threatening gynaecological emergencies (G-PLE) and of the cases of Severe morbidity (SM) among women consulting for acute pelvic pain.

To construct reliable quality indicators, principal components analysis and Cronbach's α statistics will be performed to determine the underlying dimensions. Construct validity of indicators will be assessed by testing predefined hypotheses about relationship between G-PLE and or SM and quality indicators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• French-speaking gynaecological emergencies departments leaned with a public maternity volunteers to take part in the study.

• Sample of files resulting from the principal centers recruiters

Exclusion Criteria:

Related Conditions & MeSH terms

• Gynecology
• Maternal Morbidity
• Obstetrics
• Quality

Locations

Country	Name	City	State
France	Poissy Saint Germain Hospital	Poissy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of the potentially life-threatening gynaecological emergencies (G-PLE )		1 year
Primary	Incidence of severe morbidity (SM) cases		1 year