Organization of the Dietetic Service in a Hospital
Primary Purpose
Nutritional Disease, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional assessment and therapy
Standard care
Sponsored by
About this trial
This is an interventional supportive care trial for Nutritional Disease focused on measuring dietitic service, organization of service
Eligibility Criteria
Inclusion Criteria:
- adult
- acutely admitted to hospital
Exclusion Criteria:
- dementia
- unable to comply with the protocol
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dietetic service
standard care
Arm Description
Nutritional assessment and therapy by dietitian throughout the hospital stay
Nutritional handling by nurses supported by a dietician if needed
Outcomes
Primary Outcome Measures
re-admission-rate after discharge (%)
admission for the same diagnosis
Secondary Outcome Measures
intake of protein during hospital stay
% of estimated needs
intake of energy during hospital stay
% of estimated needs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03582202
Brief Title
Organization of the Dietetic Service in a Hospital
Official Title
Organization of the Dietetic Service in a Hospital - on the Ward or Centralized?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 18, 2015 (Actual)
Primary Completion Date
April 25, 2016 (Actual)
Study Completion Date
April 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Rikardt Andersen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In Denmark the dieticians can be organized centrally and called upon if needed, or locally in larger units, or very locally related to bed-units. The organization form is based on tradition not on measurements of quality. We wanted to compare the very local form with the traditional centralized.
Methods: Randomized, unblinded, parallel design. The intervention group (IT) was nutritionally handled by the dietician, and the control group (C) by the nurses as previously with the possibility for dietetic help from the center.
Detailed Description
All patients were screened by NRS-2002 and had their estimated needs calculated (equations in IT, tables in C). The IT was in addition assessed for adapted weight-loss, counseled with a plan for nutrition and followed-up daily by the dietician if at nutritional risk. All patients were re-screened weekly and had their intake registered. Hand-grib-strength (HGS) was measured in both groups at admittance and discharge, and weight three times weekly.
The primary endpoint was re-admission rate to hospital within 2 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Disease, Malnutrition
Keywords
dietitic service, organization of service
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled
Masking
Outcomes Assessor
Masking Description
Results handled without knowledge of randomization group
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietetic service
Arm Type
Active Comparator
Arm Description
Nutritional assessment and therapy by dietitian throughout the hospital stay
Arm Title
standard care
Arm Type
Placebo Comparator
Arm Description
Nutritional handling by nurses supported by a dietician if needed
Intervention Type
Procedure
Intervention Name(s)
Nutritional assessment and therapy
Intervention Description
Nutritional screening, nutritional plan, follow-up and instructions on discharge
Intervention Type
Procedure
Intervention Name(s)
Standard care
Intervention Description
Nutritional handling by nurse
Primary Outcome Measure Information:
Title
re-admission-rate after discharge (%)
Description
admission for the same diagnosis
Time Frame
2 months
Secondary Outcome Measure Information:
Title
intake of protein during hospital stay
Description
% of estimated needs
Time Frame
1 week
Title
intake of energy during hospital stay
Description
% of estimated needs
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult
acutely admitted to hospital
Exclusion Criteria:
dementia
unable to comply with the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Organization of the Dietetic Service in a Hospital
We'll reach out to this number within 24 hrs