Clinical trial NCT01081587: Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children
Official title: Developing an Organization to Improve the Screening and Care of Starved Children in Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorders
Keywords: Non MeSH terms:
Children
Malnutrition
Computer Clinical Decision Support System
Cluster randomized trial
Healthcare workers
Guideline adherence
Patient safety
MeSH terms:
Nutrition Surveys
Secondary Prevention
Pediatrics
Child Care
Health Personnel
Reminder Systems
Intervention Studies
Quality of Health Care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 1457
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This cluster-randomized trial will evaluate the impact of a multifaceted intervention (including electronic medical alerts) coordinated by a Nutritional Support Team, on adherence to recommended practices for care of starved children, among health personnel of a large university hospital. A key component of the study is to assess whether improved adherence to guidelines leads to a reduction in rates of complications.


Eligibility criteria: Inclusion Criteria:

* medical and surgical units in a large teaching hospital providing pediatric acute care.
* any hospital staff with direct patient care who are affiliated with a single unit (includes physicians, nurses, nursing assistants, physiotherapists, dieticians.
* all children recorded as malnourished at their entrance in hospital

Exclusion Criteria:

* neonatal and intensive care units.
* any hospital staff with direct patient care who are not affiliated with a single unit.
* age under one month, liver or kidney abnormalities, severe heart failure, stay less than 2 days.

Primary outcomes:
measure: Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring)
timeFrame: At least 2 days depending on the hospitalisation time
Secondary outcomes:
measure: Incidence of complications
timeFrame: At least 2 days depending on the hospitalisation time
measure: Nutritional status evolution
timeFrame: At least 2 days depending on the hospitalisation time
measure: Mean length and cost of stay
timeFrame: At least 2 days depending on the hospitalisation time
measure: Appropriate call-in Nutritional Support Team
timeFrame: At least 2 days depending on the hospitalisation time
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant
Study officials:
affiliation: Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant (Bron, France)
name: Noël PERETTI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duclos A, Touzet S, Restier L, Occelli P, Cour-Andlauer F, Denis A, Polazzi S, Colin C, Lachaux A, Peretti N; PREDIRE Study Group. Implementation of a computerized system in pediatric wards to improve nutritional care: a cluster randomized trial. Eur J Clin Nutr. 2015 Jul;69(7):769-75. doi: 10.1038/ejcn.2014.288. Epub 2015 Feb 4.
citation: Touzet S, Duclos A, Denis A, Restier-Miron L, Occelli P, Polazzi S, Betito D, Gamba G, Cour-Andlauer F, Colin C, Lachaux A, Peretti N; PREDIRE Study Group. Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial. BMC Health Serv Res. 2013 Mar 22;13:107. doi: 10.1186/1472-6963-13-107.