Impact of Monitoring Quality Indicators in Maternity Departments on Mother and Infant Health (MATICUS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01459978
First received: September 20, 2011
Last updated: January 29, 2014
Last verified: December 2011
  Purpose

Hypothesis: Continuously monitor quality indicators with a specific method (CUSUM: Cumulative Sum) will increase the awareness of health care staff in maternity and permit rapid detection of a small dip in performance in order to enable prompt investigations and corrective measures when necessary , which decrease maternal and neonatal mortality and morbidity.

Objective: To assess the impact of Cumulative Sum (CUSUM) charts used as a maternity dashboard to decreases maternal and neonatal mortality and morbidity.

Design: Step-wedge cluster-randomized trial with prospective analyses of collected data.

Setting: ten Maternity departments in France. Population: Data from 60 000 women and infants could be collected over 2 year's period.

Method: Cumulative sum (CUSUM) charts were used to monitor the rate of quality indicators previously selected by Delphi method.

Main Outcome Measures: Composite outcome that considers multiple clinical events : mortality, adverse outcomes for women and newborn.


Condition Intervention
Obstetric; Injury
Injury
Other: CUmulative SUM (CUSUM) Chart

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Impact of Using Cumulative SUM (CUSUM) Control Chart in Maternity Department on Mother and Infant Health: a Cluster Randomized Trial

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Indicator of mother health [ Time Frame: After 24 months ] [ Designated as safety issue: Yes ]

    is a composite outcome taking into account :

    1. - mortality,
    2. - complications of pre-eclampsia

      • Hemolysis ,Elevated Liver enzymes, Low Platelet syndrome (HELLP):
      • Disseminated intravascular coagulation (DIC)
      • eclampsia
      • retro-placental hematoma,
    3. - postpartum hemorrhage
    4. - severe bleeding
    5. - thromboembolism:

      • Phlebitis
      • Pulmonary embolism
    6. - postpartum infections
    7. - severe perineal injury
    8. - need of intensive care transfer for women

  • Indicator of newborn health [ Time Frame: After 24 months ] [ Designated as safety issue: Yes ]

    is a composite outcome of mortality and morbidity. Morbidities taken into account several clinical events:

    1. - postnatal deaths (8days 1 month)
    2. - prematurity: medical or spontaneous
    3. - low birth weight (weight less than 2 kg at 37 weeks)
    4. - maternal-fetal infection: occurring in the first hours of life (germs: B streptococcus, E. coli, streptococcus, non-B)
    5. - transfer resuscitation term
    6. - chromosomal abnormalities with absence of screening
    7. - malformations without screening and diagnostic


Secondary Outcome Measures:
  • Women satisfaction [ Time Frame: After 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60000
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Early CUSUM result group

Phase 1: 3 months testing and observation period. During this phase, rates of each quality indicator selected will be collected to adjust the acceptable and unacceptable rate set by practitioners of each maternity.

Phase 2: results of the CUmulative SUM (CUSUM) will be provided for a period of 12 months (Early CUSUM result group), Phase 3: maternity will continue to receive the results of the CUmulative SUM (CUSUM) for a period of 12 months,

Other: CUmulative SUM (CUSUM) Chart

Intervention is described as follows:

Step 1: Implementation of the CUmulative SUM (CUSUM)control chart using available medical data Step 2: Submission of monthly results to the coordinator of each participating center (if CUmulative SUM (CUSUM) results period).

Step 3: When an alarm is generated, the steering committee will meet with maternity staff to find the causes of these alerts and propose

Other Name: CUmulative SUM (CUSUM) Chart
CUSUM result Delayed group
Phase 1: 3 months testing and observation period. During this phase, rates of each quality indicator selected will be collected to adjust the acceptable and unacceptable rate set by practitioners of each maternity Phase 2: the results of CUmulative SUM (CUSUM) will not be shared. Phase 3: group receive CUmulative SUM (CUSUM) result (CUSUM result Delayed group) during the same period 12 months

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Participating Center

Ten Maternity departments in France will participate to the study (Table1)

Criteria

Inclusion Criteria:

  • All deliveries during the study period:
  • Regardless of the mode of delivery: vaginal delivery, cesarean section, spontaneous or induced delivery
  • Regardless of the pregnancy term
  • Women followed or not from the first trimester of pregnancy in the concerned maternity
  • New born during the study period

Exclusion Criteria:

  • Pregnancies that ended with foetal death in UTERO or pregnancy termination for medical reasons
  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: NCT01459978

Contacts
Contact: Rym BOULKEDID, Phd 0033 1 40 03 23 46 rym.boulkedid@rdb.aphp.fr
Contact: Olivier Sibony, Professor 0033 1 40 03 47 89 olivier.sibony@rdb.aphp.fr

Locations
France
Robert Debré Hospital Not yet recruiting
Paris, France, 75019
Contact: Rym BOULKEDID    +33 (0) 1 40 03 23 46    rym.boulkedid@rdb.aphp.fr   
Contact: Olivier Sibony    +33 (0) 1 40 03 47 89    olivier.sibony@rdb.aphp.fr   
Principal Investigator: Rym BOULKEDID, Phd         
Boulkedid Recruiting
Paris, France, 75019
Contact: Rym Boulkedid    +33140032393    rym.boulkedid@rdb.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Rym BOULKEDID Hopital Robert Debre, Clinical Epidemiology Unit
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01459978     History of Changes
Other Study ID Numbers: PHRQ1032
Study First Received: September 20, 2011
Last Updated: January 29, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
CUmulative SUM (CUSUM)
quality indicators
obstetrics

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014