SEPREVEN: a Stepped-wedge Randomised Controlled Trial (SEPREVEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02598609

Recruitment Status : Completed

First Posted : November 6, 2015

Last Update Posted : December 29, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Paris 12 Val de Marne University

Ministry of Health, France

Information provided by (Responsible Party):

Dr Caeymaex Laurence, Centre Hospitalier Intercommunal Creteil

Study Description

Brief Summary:

Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for a high morbidity and mortality. Possible severe adverse events are central line associated bloodstream infections (CLABSI), ventilator and catheter associated adverse events and medication errors. Severity of the patient's outcome after an adverse event can be classified using the National Coordinating Council for Medication Error Reporting and Preventing (NCC MERP) Index for categorizing medication errors.

The study will test the hypothesis that rates of adverse events in NICU patients will be reduced by the implementation of an educational program for the NICU caregivers (nurses and physicians), consisting of strategies for recognizing and preventing adverse events in their unit. These strategies will be oriented to prevent CLABSI, medication errors, skin and nasal complications and ventilator and catheter-associated adverse events.

This trial has a stepped wedge cluster design, in which the NICUs from 12 hospitals in France will be randomized to the timing of implementation of the educational program.

In order to describe the adverse events occurring during the study period, an anonymous voluntary adverse event reporting system will be provided to the caregivers of the participating units. A nested study will examine how caregivers communicate with the patients' parents in case of adverse event (disclosure or not, and caregivers' reasons).

The rates of adverse events will be measured retrospectively using a neonatal NICU trigger tool.

Condition or disease	Intervention/treatment	Phase
Intensive Care Units, Neonatal Misadventures to Patients During Surgical and Medical Care Catheter-related Bloodstream Infection (CRBSI) Nos Quality of Healthcare Ventilator Adverse Event Nosocomial Pneumonia Immature Newborn Skin Lesion Extravasation Injury Nasal Injury Intubation Complication Medication Administered in Error IV Catheter Nos Deep Venous Thrombosis	Behavioral: Education program for NICU caregivers	Not Applicable

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	8000 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Study on Preventing Adverse Events in Neonates (SEPREVEN): a Stepped-wedge Randomised Controlled Trial to Reduce Adverse Event Rates in the NICU
Actual Study Start Date :	November 23, 2015
Actual Primary Completion Date :	March 30, 2020
Actual Study Completion Date :	December 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Cluster A Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster A. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 4 months. The intervention is implemented during 4 months. The length of the post interventional period is 12 months.	Behavioral: Education program for NICU caregivers standardized educational program : learning how to retrospectively analyze causes of a medical error in the NICU in order to prevent it (compulsory) implementation of a central line maintenance bundle and checklist, of a central line insertion bundle and checklist and of a daily goals bundle and checklist. (compulsory) poster for prevention of extravasation injuries
Cluster B Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster B. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 8 months. The intervention is implemented during 4 months. The length of the post interventional period is 8 months.	Behavioral: Education program for NICU caregivers standardized educational program : learning how to retrospectively analyze causes of a medical error in the NICU in order to prevent it (compulsory) implementation of a central line maintenance bundle and checklist, of a central line insertion bundle and checklist and of a daily goals bundle and checklist. (compulsory) poster for prevention of extravasation injuries
Cluster C Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster C. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 12 months. The intervention is implemented during 4 months. The length of the post interventional period is 4 months.	Behavioral: Education program for NICU caregivers standardized educational program : learning how to retrospectively analyze causes of a medical error in the NICU in order to prevent it (compulsory) implementation of a central line maintenance bundle and checklist, of a central line insertion bundle and checklist and of a daily goals bundle and checklist. (compulsory) poster for prevention of extravasation injuries

Outcome Measures

Primary Outcome Measures :

Rates of adverse events (total number/1000 patient-days) [ Time Frame: 20 months ]
Assessment of the effectiveness of the program on reducing the rates of adverse events (number of adverse events/1000 patient-days) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool. An adverse event is defined here as an injury, large or small, caused by the use (including non-use) of a drug, test, or medical treatment.(Trigger tool kit, Raju Ped Research). Preventable adverse events and non preventable adverse events secondary to expected complications or side effects are both included.

Secondary Outcome Measures :

Rate of adverse events (Percentage of patient admissions with an adverse event) over time during the study period [ Time Frame: 20 months ]
Assessment of the effectiveness of the program on reducing the rate of adverse events (percentage of patient admissions with an adverse event) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340), over time during the inclusion period
Rate of adverse events (number of adverse events per 100 NICU admissions) over time during the study period [ Time Frame: 20 months ]
Assessment of the effectiveness of the program on reducing the rates of adverse events (number of adverse events per 100 admissions) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340) over time
Rates of preventable adverse events (total number/1000 patient-days) [ Time Frame: 20 months ]
Assessment of the effectiveness of the program on reducing the rates of preventable adverse events (number of adverse events/1000 patient-days) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool. An adverse event is defined here as an injury, large or small, caused by the use (including non-use) of a drug, test, or medical treatment. (see Trigger tool kit definitions and Raju Ped Research) Preventability is assessed according to the existence of an "error". Expected complications or side effects from therapeutic or diagnostic interventions are generally non-preventable, and hence are considered complications. (see Raju, Pediatric Research) Healthcare associated infections are considered preventable adverse events.
Rates of CLABSI, number per 1000 catheter-days in the 12 participating NICUs in France [ Time Frame: 20 months ]
Assessment of the effectiveness of the program on reducing the rates of Central line associated blood stream infections defined using the Primary Blood Stream Infections and LCBSI criteria (CDC/NHSN Device-Associated Module BSI January 2015), collected prospectively in the 12 participating NICUs. Analysis will include subgroups according to patient's characteristics and contextual factors (nurse staffing, unit occupancy, type of unit).
Rates of unplanned extubations, number per 100 ventilator-days and number per 100 ventilator-hours in the 12 participating NICUs in France. [ Time Frame: 20 months ]
Assessment of the effectiveness of the program on reducing the rates of adverse events caused/lead by unplanned extubations measured using the retrospective trigger tool chart review (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool.
Identify factors associated with and consequences of Unprogrammed extubation in NICU patients [ Time Frame: 20 months ]
Unprogrammed extubation: description of prospectively reported factors associated with UE (context and cause), and patients' characteristics, as well as HCP's assessment of preventability of this UE (multiple choices questionnaire) in the participating units. Prospective collection of outcome 30 minutes and 24 hours after UE (reintubation/ non invasive ventilation or spontaneous breathing and outcome severity grading) according to reported causal factors and patients' characteristics
Rates of severe adverse events [ Time Frame: 20 months ]
Assessment of the effectiveness of the program on reducing the rates of severe adverse events collected using a multisource prospective voluntary anonymous collection. Results will include control charts, and include patients' characteristics and contextual factors over time.
Describe rates of medication errors in NICU patients [ Time Frame: 20 months ]
Assessment of the effectiveness of the program on reducing the rates of adverse events related to medication errors, measured using the retrospective trigger tool chart review (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool; A medication error is defined here as any preventable event that causes or leads to inappropriate medication use with patient harm while the medication is in the control of the health care professional in the NICU. (see Raju Ped Research).
Identify factors associated with and consequences of medication errors in NICU patients [ Time Frame: 20 months ]
Type of medication, of error and consequences and patients' and unit's characteristics are collected prospectively in the participating NICUs
Identify factors associated with and consequences of catheter-related adverse in the NICU [ Time Frame: 20 months ]
Type of adverse event, consequence and patients' and unit's characteristics are collected prospectively in the participating NICUs
Rates of catheter-related adverse events, number per 1000 catheter-days [ Time Frame: 20 months ]
Assessment of the effectiveness of the program on reducing the rates of catheter-related adverse events collected prospectively and using the retrospective trigger tool chart review (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340) in the 12 participating NICUs
Identify number and types of medical errors collected in the 12 NICUs in France [ Time Frame: 20 months ]
Number and types of medical errors are defined as catheter related (central line), medication, ventilation, skin lesions, nasal injury, extravasation, enteral feeding, temperature control, unprogrammed extubation, surgical complications, diagnostic error or delay, parenteral fluid/nutrition adverse event, and, in existing, others. These "errors" are collected prospectively in each participating unit during the 20 months period, using a multi-source collection file (manual, anonymous and voluntary and/or institutional). A Medical Error is defined here as an error in health care, due to a failure of the planned action to be completed as intended, or using a wrong plan of action to achieve the goal, and excluding near misses. (see Raju Pediatric Research) Errors are included independently of the harm caused to the patient. Descriptions will include patients' characteristics and contextual factors.
Identify Severity of adverse events in the 12 participating NICUs in France [ Time Frame: 20 months ]
Identify Severity of adverse events, rated prospectively using the National Coordinating Council for Medication Error Reporting and Prevention Index for Categorizing Errors (NCC MERP, 2001)(including infectious and non infectious adverse events). Severity is described according to contextual factors and patients' characteristics.
Describe late-onset infections types and characteristics in NICU patients in France [ Time Frame: 20 months ]
Late-onset infections are defined according to the January 2015 CDC/NHSN Surveillance Definitions for all types of Specific Types of infections, for Primary Blood Stream Infections and for neonatal Ventilator associated pneumonia (Hospital-Acquired infections for neonates). Clinical sepsis without laboratory proven infection is included. Description includes type on infection, clinical and bacteriological characteristics and type of consequence - data are collected prospectively by physicians. Descriptions will be done including patients' characteristics and contextual factors.
Skin tolerance to cutaneous antisepsis : Dermatitis score results before and after an antisepsis procedure for umbilical and/or PICC catheter insertion in premature neonates born less than 32 weeks gestational age and aged less than 15 days. [ Time Frame: 20 months ]
Dermatitis scoring is based on the existing Dermatitis score used by Garland JS (Garland JS et al. J Perinatol 2009), traduced in french (Score sheet available on demand). Score ranges from 0 (no dermatitis) to 4, with severe dermatitis >= 2. Score is completed propectively by the nurse in care, before and untill 5 after the procedure. Scores wil be compared according to antiseptic procedure and patient's characteristics.
Description of Nasal scores results during the use of noninvasive nasal ventilation interfaces in neonates born less than 32 weeks of gestational age and aged less than 15 days [ Time Frame: 20 months ]
The nasal trauma score is based on the score used by Collins (Collins CL et al, Eur J Ped 2014). Score is completed prospectively by the nurse in care of the patient, in the first week of nasal ventilation (after extubation or not). Rates and type of nasal lesions according to interface and patient's characteristics will be described.
Identify characteristics ad factors associated with severe extravasation injuries in the 12 NICUs [ Time Frame: 20 months ]
Extravasation injuries from peripherally inserted short catheter score is rated from I to IV based on the classification described b are collected prospectively using the score described by Casanova (Casanova D et al, Br J Plastic Surgery 2001). Score is rated prospectively by nurse in care; for severe extravasation, context of extravasation (infused substances, site,...), patients' characteristics and consequences are collected prospectively.
Description of characteristics of disclosed and undisclosed adverse events to the patients' parents, caregivers' motivations, and perceived parental reactions [ Time Frame: 20 months ]
For each collected adverse event, caregivers self-administered written questionnaire assessing of adverse event has been told to parent(s), heath care professional's reasons to disclosure it or not, and in case of disclosure, parental reactions according to health care professional (multiple choices)
Economical impact of the program [ Time Frame: 20 months ]
Mortality (yes/no)
Economical impact of the program [ Time Frame: 20 months ]
NICU length of stay (days)
Economical impact of the program [ Time Frame: 20 months ]
Neurological complications (Intraventricular hemorrhage, leucomalacia) for prematures
Economical impact of the program [ Time Frame: 20 months ]
Hospitalization data: morbidity for prematures bronchopulmonary dysplasia at 36 weeks (yes/no); severe retinopathia (yes/no); severe enterocolitis (yes/no)
Rate of positive and negative blood cultures in NICU patients suspected of late onset infection according to volume of blood culture [ Time Frame: 20 months ]
Prospective record on volume of blood culture and results (positive/negative)
Description of safety culture in each of the 12 participating NICUs before and after patients' inclusion period [ Time Frame: 20 months ]
Safety culture is measured by a questionnaire filled in by the healthcare providers of the 12 units, in the weeks before the beginning and after the end of the patients' inclusion period using the french traduction of the Hospital Survey On Patient Safety Culture (HSOPSC)(http://www.ahrq.gov/qual/patientsafetyculture), named Questionnaire de mesure de la culture de sécurité des soins en milieu hospitalier, validated by the CCECQA. A comparison of the results before and after the study will be described globally and per unit.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	1 Day to 20 Weeks (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria :

Patients hospitalized during the study period in one of the 12 participating Neonatal Intensive Care Units
Corrected Gestational age not exceeding 42 weeks +6 days at the time of admission in the NICU
Length of hospitalisation in the NICU > 2 days
No parental objection to the anonymous data collection of their newborn(s)' clinical data, after written information

Exclusion Criteria:

More than 42 weeks +6 days of corrected gestational age on admission in the NICU
Length of hospitalization in the NICU < or = 2 days
Parental objection to the anonymous data collection of their newborn(s)' clinical data

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598609

Locations

Layout table for location information

France
CHU Strasbourg Hautepierre
Strasbourg, Alsace, France, 67000
CHU Grenoble
Grenoble, Auvergne Rhône Alpes, France, 38000
CHU Lille Jeanne de Flandres
Lille, Hauts De France, France, 59000
CHI Creteil
Creteil, Ile De France, France, 94000
CHU Bicêtre, APHP
Le Kremlin Bicêtre, Ile De France, France, 94270
CHU Robert Debré, APHP
Paris, Ile De France, France, 75019
CH Poissy
Poissy, Ile De France, France, 78300
CH Pontoise René Dubos
Pontoise, Ile De France, France, 95000
Centre Hospitalier Delafontaine
St Denis, Ile De France, France, 93210
CHU Caen
Caen, Normandie, France, 14000
CHU Angers
Angers, Pays De La Loire, France, 49000
CHU Nice Archet
Nice, Provence Alpes Cote d'Azur, France, 06000

Sponsors and Collaborators

Dr Caeymaex Laurence

Paris 12 Val de Marne University

Ministry of Health, France

Investigators

Layout table for investigator information

Principal Investigator:	Laurence Caeymaex, MD, PhD	CHI Creteil, Paris Est University

More Information

Publications:

Sharek PJ, Horbar JD, Mason W, Bisarya H, Thurm CW, Suresh G, Gray JE, Edwards WH, Goldmann D, Classen D. Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Pediatrics. 2006 Oct;118(4):1332-40. doi: 10.1542/peds.2006-0565.

Sharek PJ. The Emergence of the Trigger Tool as the Premier Measurement Strategy for Patient Safety. AHRQ WebM&M. 2012 May 1;2012(5):120. No abstract available.

Chedoe I, Molendijk H, Hospes W, Van den Heuvel ER, Taxis K. The effect of a multifaceted educational intervention on medication preparation and administration errors in neonatal intensive care. Arch Dis Child Fetal Neonatal Ed. 2012 Nov;97(6):F449-55. doi: 10.1136/fetalneonatal-2011-300989. Epub 2012 Apr 5.

Dabliz R, Levine S. Medication safety in neonates. Am J Perinatol. 2012 Jan;29(1):49-56. doi: 10.1055/s-0031-1285831. Epub 2011 Aug 22.

Palmero D, Di Paolo ER, Beauport L, Pannatier A, Tolsa JF. A bundle with a preformatted medical order sheet and an introductory course to reduce prescription errors in neonates. Eur J Pediatr. 2016 Jan;175(1):113-9. doi: 10.1007/s00431-015-2607-4. Epub 2015 Aug 15.

Fisher D, Cochran KM, Provost LP, Patterson J, Bristol T, Metzguer K, Smith B, Testoni D, McCaffrey MJ. Reducing central line-associated bloodstream infections in North Carolina NICUs. Pediatrics. 2013 Dec;132(6):e1664-71. doi: 10.1542/peds.2013-2000. Epub 2013 Nov 18.

Smulders CA, van Gestel JP, Bos AP. Are central line bundles and ventilator bundles effective in critically ill neonates and children? Intensive Care Med. 2013 Aug;39(8):1352-8. doi: 10.1007/s00134-013-2927-7. Epub 2013 Apr 25.

Schulman J, Stricof R, Stevens TP, Horgan M, Gase K, Holzman IR, Koppel RI, Nafday S, Gibbs K, Angert R, Simmonds A, Furdon SA, Saiman L; New York State Regional Perinatal Care Centers. Statewide NICU central-line-associated bloodstream infection rates decline after bundles and checklists. Pediatrics. 2011 Mar;127(3):436-44. doi: 10.1542/peds.2010-2873. Epub 2011 Feb 21.

Casanova D, Bardot J, Magalon G. Emergency treatment of accidental infusion leakage in the newborn: report of 14 cases. Br J Plast Surg. 2001 Jul;54(5):396-9. doi: 10.1054/bjps.2001.3593.

Collins CL, Barfield C, Horne RS, Davis PG. A comparison of nasal trauma in preterm infants extubated to either heated humidified high-flow nasal cannulae or nasal continuous positive airway pressure. Eur J Pediatr. 2014 Feb;173(2):181-6. doi: 10.1007/s00431-013-2139-8. Epub 2013 Aug 18.

Farquhar C, Armstrong S, Kim B, Masson V, Sadler L. Under-reporting of maternal and perinatal adverse events in New Zealand. BMJ Open. 2015 Jul 23;5(7):e007970. doi: 10.1136/bmjopen-2015-007970.

Raju TN, Suresh G, Higgins RD. Patient safety in the context of neonatal intensive care: research and educational opportunities. Pediatr Res. 2011 Jul;70(1):109-15. doi: 10.1203/PDR.0b013e3182182853.

Garland JS, Alex CP, Uhing MR, Peterside IE, Rentz A, Harris MC. Pilot trial to compare tolerance of chlorhexidine gluconate to povidone-iodine antisepsis for central venous catheter placement in neonates. J Perinatol. 2009 Dec;29(12):808-13. doi: 10.1038/jp.2009.161. Epub 2009 Oct 8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Caeymaex L, Astruc D, Biran V, Marcus L, Flamein F, Le Bouedec S, Guillois B, Remichi R, Harbi F, Durrmeyer X, Casagrande F, Le Sache N, Todorova D, Bilal A, Olivier D, Reynaud A, Jacquin C, Roze JC, Layese R, Danan C, Jung C, Decobert F, Audureau E. An educational programme in neonatal intensive care units (SEPREVEN): a stepped-wedge, cluster-randomised controlled trial. Lancet. 2022 Jan 22;399(10322):384-392. doi: 10.1016/S0140-6736(21)01899-7.

Caeymaex L, Lebeaux C, Roze JC, Danan C, Reynaud A, Jung C, Audureau E. Study on preventing adverse events in neonates (SEPREVEN): A stepped-wedge randomised controlled trial to reduce adverse event rates in the NICU. Medicine (Baltimore). 2020 Jul 31;99(31):e20912. doi: 10.1097/MD.0000000000020912.

Layout table for additonal information

Responsible Party:	Dr Caeymaex Laurence, Dr, PhD, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:	NCT02598609
Other Study ID Numbers:	SEPREVEN
First Posted:	November 6, 2015 Key Record Dates
Last Update Posted:	December 29, 2020
Last Verified:	December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Dr Caeymaex Laurence, Centre Hospitalier Intercommunal Creteil:


Adverse event Neonatal Intensive Care Unit Catheter-related Bloodstream Infection (CRBSI) nos Extravasation injury	Medication error Central venous catheter complication Unprogrammed extubation

Additional relevant MeSH terms:

Layout table for MeSH terms

Sepsis Healthcare-Associated Pneumonia Thrombosis Venous Thrombosis Wounds and Injuries Infections Pneumonia Respiratory Tract Infections Lung Diseases Respiratory Tract Diseases	Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Cross Infection Iatrogenic Disease Disease Attributes

To Top