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

Primary Purpose

Nutrition Disorders

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Access to a Computerized Clinical Decision Support System (CCDDS)

Education of Healthcare workers

Local assistance by a dietician

About this trial

This is an interventional prevention trial for Nutrition Disorders focused on measuring 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

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nutritional Support Team

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring)

Secondary Outcome Measures

Incidence of complications

Nutritional status evolution

Mean length and cost of stay

Appropriate call-in Nutritional Support Team

Full Information

NCT ID

NCT01081587

First Posted

February 19, 2010

Last Updated

May 14, 2013

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT01081587

Brief Title

Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children

Acronym

PREDIRE

Official Title

Developing an Organization to Improve the Screening and Care of Starved Children in Hospital

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1457 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nutritional Support Team

Arm Type

Experimental

Arm Title

Usual care

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Access to a Computerized Clinical Decision Support System (CCDDS)

Intervention Description

Automatic CCDSS will alert physician for each case of malnourished using an algorithm based on age, sex, weight and size of each hospitalized children.

Intervention Type

Behavioral

Intervention Name(s)

Education of Healthcare workers

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Local assistance by a dietician

Intervention Description

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.

Primary Outcome Measure Information:

Title

Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring)

Time Frame