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

Completed

• Conditions: Quality; Obstetrics; Maternal Morbidity; Gynecology

• Registration Number: NCT02274441
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Study Start: 2015-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of the potentially life-threatening gynaecological emergencies (G-PLE )	1 year
Incidence of severe morbidity (SM) cases	1 year

Trial Locations

Locations (1)

Poissy Saint Germain Hospital; 🇫🇷 Poissy, France