Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children (PREDIRE)
This study has been completed.
Sponsor:
Hospices Civils de Lyon
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
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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
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 May 22, 2013