Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children (PREDIRE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01081587
First received: February 19, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Nutrition Disorders
Procedure: Access to a Computerized Clinical Decision Support System (CCDDS)
Behavioral: Education of Healthcare workers
Other: Local assistance by a dietician

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Developing an Organization to Improve the Screening and Care of Starved Children in Hospital

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring) [ Time Frame: At least 2 days depending on the hospitalisation time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of complications [ Time Frame: At least 2 days depending on the hospitalisation time ] [ Designated as safety issue: Yes ]
  • Nutritional status evolution [ Time Frame: At least 2 days depending on the hospitalisation time ] [ Designated as safety issue: Yes ]
  • Mean length and cost of stay [ Time Frame: At least 2 days depending on the hospitalisation time ] [ Designated as safety issue: No ]
  • Appropriate call-in Nutritional Support Team [ Time Frame: At least 2 days depending on the hospitalisation time ] [ Designated as safety issue: No ]

Enrollment: 1457
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional Support Team Procedure: Access to a Computerized Clinical Decision Support System (CCDDS)
Automatic CCDSS will alert physician for each case of malnourished using an algorithm based on age, sex, weight and size of each hospitalized children.
Behavioral: Education of Healthcare workers
Education of the hospital staff to evidence-based practices in malnutrition care will be proposed in the experimental arm. Specific training will be targeted on participants according to their function.
Other: Local assistance by a dietician
Assistance will be conducted locally by a local dietician. Periodic multidisciplinary meetings will be attended by the hospital staff belonging to the intervention arm, including the analysis of clinical incidents related to nutrition care.
Active Comparator: Usual care Procedure: Access to a Computerized Clinical Decision Support System (CCDDS)
Automatic CCDSS will alert physician for each case of malnourished using an algorithm based on age, sex, weight and size of each hospitalized children.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081587

Locations
France
Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Noël PERETTI, MD, PhD Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant (Bron, France)
  More Information

No publications provided by Hospices Civils de Lyon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01081587     History of Changes
Other Study ID Numbers: 2008.522/23
Study First Received: February 19, 2010
Last Updated: May 14, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
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

Additional relevant MeSH terms:
Nutrition Disorders
Malnutrition

ClinicalTrials.gov processed this record on July 23, 2014