Impact of Monitoring Quality Indicators in Maternity Departments on Mother and Infant Health (MATICUS)
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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 |
- Indicator of mother health [ Time Frame: After 24 months ] [ Designated as safety issue: Yes ]
is a composite outcome taking into account :
- - mortality,
- complications of pre-eclampsia
- Hemolysis ,Elevated Liver enzymes, Low Platelet syndrome (HELLP):
- Disseminated intravascular coagulation (DIC)
- eclampsia
- retro-placental hematoma,
- - postpartum hemorrhage
- - severe bleeding
- thromboembolism:
- Phlebitis
- Pulmonary embolism
- - postpartum infections
- - severe perineal injury
- - 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:
- - postnatal deaths (8days 1 month)
- - prematurity: medical or spontaneous
- - low birth weight (weight less than 2 kg at 37 weeks)
- - maternal-fetal infection: occurring in the first hours of life (germs: B streptococcus, E. coli, streptococcus, non-B)
- - transfer resuscitation term
- - chromosomal abnormalities with absence of screening
- - malformations without screening and diagnostic
- 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: | November 2013 |
| Estimated 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 |
Participating Center
Ten Maternity departments in France will participate to the study (Table1)
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| 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 |
| 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 | |
| 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: | April 11, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
CUmulative SUM (CUSUM) quality indicators obstetrics |
ClinicalTrials.gov processed this record on May 19, 2013