SEPREVEN: a Stepped-wedge Randomised Controlled Trial

NCT02598609 | Completed

• 1 other identifier: SEPREVEN
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rates of adverse events (total number/1000 patient-days)

  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.

  20 months

Secondary Outcomes (24)

• Rate of adverse events (Percentage of patient admissions with an adverse event) over time during the study period

  20 months

• Rate of adverse events (number of adverse events per 100 NICU admissions) over time during the study period

  20 months

• Rates of preventable adverse events (total number/1000 patient-days)

  20 months

• Rates of CLABSI, number per 1000 catheter-days in the 12 participating NICUs in France

  20 months

• Rates of unplanned extubations, number per 100 ventilator-days and number per 100 ventilator-hours in the 12 participating NICUs in France.

  20 months

Study Arms (3)

Cluster A

OTHER

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

Cluster B

OTHER

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

Cluster C

OTHER

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

Interventions

Education program for NICU caregivers BEHAVIORAL

* 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 A; Cluster B; Cluster C

Eligibility Criteria

• Age: 1 Day - 20 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Caeymaex Laurence: lead
• Paris 12 Val de Marne University: collaborator
• Ministry of Health, France: collaborator

Study Sites (12)

CHU Strasbourg Hautepierre

Strasbourg, Alsace, 67000, France

Location

CHU Grenoble

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Location

CHU Lille Jeanne de Flandres

Lille, Hauts-de-France, 59000, France

Location

CHU Caen

Caen, Normandy, 14000, France

Location

CHU Angers

Angers, Pays de la Loire Region, 49000, France

Location

CHU Nice Archet

Nice, Provence-Alpes-Côte d'Azur Region, 06000, France

Location

CHI Creteil

Créteil, Île-de-France Region, 94000, France

Location

CHU Bicêtre, APHP

Le Kremlin-Bicêtre, Île-de-France Region, 94270, France

Location

CHU Robert Debré, APHP

Paris, Île-de-France Region, 75019, France

Location

CH Poissy

Poissy, Île-de-France Region, 78300, France

Location

CH Pontoise René Dubos

Pontoise, Île-de-France Region, 95000, France

Location

Centre Hospitalier Delafontaine

Saint-Denis, Île-de-France Region, 93210, France

Location

Related Publications (18)

• 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.

  PMID: 17015521 BACKGROUND

• 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.

  PMID: 23667349 BACKGROUND

• 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.

  PMID: 22491014 BACKGROUND

• 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.

  PMID: 21861251 BACKGROUND

• 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.

  PMID: 26272253 BACKGROUND

• 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.

  PMID: 24249819 BACKGROUND

• 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.

  PMID: 23615702 BACKGROUND

• 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.

  PMID: 21339265 BACKGROUND

• 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.

  PMID: 11428769 BACKGROUND

• 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.

  PMID: 23955516 BACKGROUND

• 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.

  PMID: 26204910 BACKGROUND

• 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.

  PMID: 21386749 BACKGROUND

• 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.

  PMID: 19812587 BACKGROUND

• Yager H, Tauzin M, Durrmeyer X, Todorova D, Storme L, Debillon T, Casagrande F, Jung C, Audureau E, Layese R, Caeymaex L; SEPREVEN Study Group. Respiratory outcomes and survival after unplanned extubation in the NICU: a prospective cohort study from the SEPREVEN trial. Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):586-593. doi: 10.1136/archdischild-2023-326679.

  PMID: 38636983 DERIVED

• Jaloustre M, Cohen R, Biran V, Decobert F, Layese R, Audureau E, Le Sache N, Chevallier M, Boukhris MR, Bolot P, Caeymaex L, Tauzin M; with the SEPREVEN study Group. Determinants of morbidity and mortality related to health care-associated primary bloodstream infections in neonatal intensive care units: a prospective cohort study from the SEPREVEN trial. Front Pediatr. 2023 May 31;11:1170863. doi: 10.3389/fped.2023.1170863. eCollection 2023.

  PMID: 37325351 DERIVED

• Passini L, Le Bouedec S, Dassieu G, Reynaud A, Jung C, Keller ML, Lefebvre A, Katty T, Baleyte JM, Layese R, Audureau E, Caeymaex L; SEPREVEN Study Group. Error disclosure in neonatal intensive care: a multicentre, prospective, observational study. BMJ Qual Saf. 2023 Oct;32(10):589-599. doi: 10.1136/bmjqs-2022-015247. Epub 2023 Mar 14.

  PMID: 36918264 DERIVED

• 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.

  PMID: 35065786 DERIVED

• 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.

  PMID: 32756081 DERIVED

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic; Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurence Caeymaex, MD, PhD

  CHI Creteil, Paris Est University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr, PhD

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: November 23, 2015
• Primary Completion: March 30, 2020
• Study Completion: December 8, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (12)