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An Educational Program to Prevent Adverse Events in Neonates : a Randomised Trial. (SEPREVEN)

This study is currently recruiting participants.
Verified October 2016 by Dr Caeymaex Laurence, Centre Hospitalier Intercommunal Creteil
Sponsor:
ClinicalTrials.gov Identifier:
NCT02598609
First Posted: November 6, 2015
Last Update Posted: October 21, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Paris 12 Val de Marne University
Ministry of Health, France
Information provided by (Responsible Party):
Dr Caeymaex Laurence, Centre Hospitalier Intercommunal Creteil
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Multifaceted Educational Program for Caregivers to Prevent Adverse Events in Neonatal Intensive Care Unit Patients, a Stepped Wedge Cluster Randomised Trial.

Resource links provided by NLM:


Further study details as provided by Dr Caeymaex Laurence, Centre Hospitalier Intercommunal Creteil:

Primary Outcome Measures:
  • Rates of adverse events/1000 patient-days [ Time Frame: 4 to 18 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


Secondary Outcome Measures:
  • Rates of preventable adverse events/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

  • Rates of CRBSI/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 measured prospectively

  • Rates of unplanned extubations/100 ventilator-days in the 12 participating NICUs in France [ Time Frame: 20 months ]
    Assessment of the effectiveness of the program on reducing the rates of unplanned extubations collected prospectively

  • Rates of medication errors/1000 patient-days in the 12 participating NICUs in France [ Time Frame: 20 months ]
    Assessment of the effectiveness of the program on reducing the rates of medication errors collected prospectively and using the retrospective trigger tool chart review

  • Description of Severity of outcome after the adverse events occurred in the 12 participating NICUs in France [ Time Frame: 20 months ]
    Describe the severity of outcome after different types of adverse events, with a prospective grading of severity using the MCC MERP Categorizing Index for each collected adverse event.

  • Description of types of adverse events occurring in NICU patients in France [ Time Frame: 20 months ]
  • Dermatitis score results before and after the use of antiseptic in neonates born less than 32 weeks of gestational age and aged less than 15 days. Prospective description of antisepsis procedure used (prospective multiple choice questionnaire). [ Time Frame: 20 months ]
    Prospective dermatitis score by the nurse in care of the patient, performed before and after cutaneous antisepsis for central line insertion, in the first 15 days of life if born before 32 weeks of gestational age. Rates of dermatitis scores passing from 0 or 1 (no dermatitis) to score 2 and more before and after antisepsis, according to antisepsis procedure and patient's characteristics (age and gestational age at birth).

  • 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 ]
    Prospective nasal score by the nurse in care of the patient, performed in the first week of nasal ventilation (after extubation or not) if less than 15 days of age and if born before 32 weeks gestational age. Rates and type of nasal lesions according to interface and patient's characteristics (age and gestational age at birth).

  • 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 ]
  • Description of severe extravasation injuries and evolution (context and rate per patients) [ Time Frame: 20 months ]
    Extravasation score rated prospectively by health care professional for each extravasation and 7 days later evolution; description of infused substances, gestational age and age of life at extravasation in patients with severe extravasation

  • Rate of positive and negative blood cultures in patients suspected of infection according to volume of blood culture [ Time Frame: 20 months ]
    Prospective record on volume of blood culture and results (positive/negative)


Estimated Enrollment: 8000
Study Start Date: November 2015
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
  • multicenter sharing of strategies to prevent adverse events in the NICU
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)
  • multicenter sharing of strategies to prevent adverse events in the NICU
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)
  • multicenter sharing of strategies to prevent adverse events in the NICU

  Eligibility

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.


Ages Eligible for Study:   up 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


Contacts
Contact: Laurence Caeymaex, MD, PhD +33-1-45175433 laurence.caeymaex@chicreteil.fr
Contact: Camille Jung, MD, PhD +33-1-45175433 camille.jung@chicreteil.fr

Locations
France
CHU Strasbourg Hautepierre Recruiting
Strasbourg, Alsace, France, 67000
Contact: Dominique Astruc, MD       Dominique.Astruc@chru-strasbourg.fr   
Principal Investigator: Dominique Astruc, MD         
CHU Grenoble Recruiting
Grenoble, Auvergne Rhône Alpes, France, 38000
Contact: Leila Marcus, MD       LMarcus@chu-grenoble.fr   
Principal Investigator: Leila Marcus, MD         
Sub-Investigator: Fabrice Cneude, MD         
CHU Lille Jeanne de Flandres Recruiting
Lille, Hauts de France, France, 59000
Contact: Damien Olivier, MD       Damien.OLIVIER2@CHRU-LILLE.FR   
Contact: Laurent Storme, MD, PhD       Laurent.STORME@CHRU-LILLE.FR   
Principal Investigator: Damien Olivier, MD         
Sub-Investigator: Florence Flamein Ballay, MD         
CHI Creteil Recruiting
Creteil, Ile de France, France, 94000
Contact: Laurence Caeymaex, MD PhD    +33664095607    laurence.caeymaex@chicreteil.fr   
Contact: Camille Jung, MD PhD       camille.jung@chicreteil.fr   
Principal Investigator: Xavier Durrmeyer, MD PhD         
Sub-Investigator: Fabrice Decobert, MD         
CHU Bicêtre, APHP Recruiting
Le Kremlin Bicêtre, Ile de France, France, 94270
Contact: Nolwenn Lesache, MD       nolwenn.lesache@aphp.fr   
Principal Investigator: Nolwenn Lesache, MD         
CHU Robert Debré, APHP Recruiting
Paris, Ile de France, France, 75019
Contact: Olivier Baud, MD PhD       olivier.baud@aphp.fr   
Principal Investigator: Ali Bilal, MD         
Sub-Investigator: Valerie Biran, MD PhD         
Sub-Investigator: Olivier Baud, MD PhD         
CH Poissy Recruiting
Poissy, Ile de france, France, 78300
Contact: Radia Remichi, MD       radia_remichi@yahoo.fr   
Contact: Pascal Boileau, MD PhD         
Principal Investigator: Radia Remichi, MD         
Sub-Investigator: Pascal Boileau, MD PhD         
CH Pontoise René Dubos Recruiting
Pontoise, Ile de france, France, 95000
Contact: Darina Todorova, MD       darina.todorova@ch-pontoise.fr   
Principal Investigator: Darina Todorova, MD         
Sub-Investigator: Saïd Merbouche, MD         
Centre Hospitalier Delafontaine Recruiting
St Denis, Ile de france, France, 93210
Contact: Pascal Bolot, MD       pascal.bolot@ch-stdenis.fr   
Principal Investigator: Pascal Boileau, MD         
Sub-Investigator: Cecile Alioux, MD         
CHU Caen Recruiting
Caen, Normandie, France, 14000
Contact: Bernard Guillois, MD, PhD       guillois-b@chu-caen.fr   
Principal Investigator: Bernard Guillois, MD PhD         
CHU Angers Recruiting
Angers, Pays de la Loire, France, 49000
Contact: Stephane Le Bouedec, MD       StLeBouedec@chu-angers.fr   
Principal Investigator: Stephane Le Bouedec, MD         
Sub-Investigator: Bertrand Leboucher, MD         
CHU Nice Archet Recruiting
Nice, Provence Alpes Cote d'Azur, France, 06000
Contact: Florence Casagrande-Magne, MD       casagrande-magne.f@chu-nice.fr   
Contact: Gwenn-Marie Verzat, MD       verzat.gm@chu-nice.fr   
Principal Investigator: Florence Casagrande-Magne, MD         
Sub-Investigator: Gwenn Marie Verzat, MD         
Sponsors and Collaborators
Dr Caeymaex Laurence
Paris 12 Val de Marne University
Ministry of Health, France
Investigators
Principal Investigator: Laurence Caeymaex, MD, PhD CHI Creteil, Paris Est University
  More Information

Publications:

Responsible Party: Dr Caeymaex Laurence, Dr, PhD, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02598609     History of Changes
Other Study ID Numbers: SEPREVEN
First Submitted: November 4, 2015
First Posted: November 6, 2015
Last Update Posted: October 21, 2016
Last Verified: October 2016
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:
Wounds and Injuries
Pneumonia
Thrombosis
Venous Thrombosis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases