Organization of the Dietetic Service in a Hospital

• ClinicalTrials.gov Identifier: NCT03582202
• Recruitment Status: Completed
• First Posted: July 10, 2018
• Last Update Posted: July 16, 2018
• Sponsor: Jens Rikardt Andersen
• Information provided by (Responsible Party): Jens Rikardt Andersen, University of Copenhagen

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.

Condition or disease	Intervention/treatment	Phase
Nutritional Disease; Malnutrition	Procedure: Nutritional assessment and therapy; Procedure: Standard care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled
• Masking: Single (Outcomes Assessor)
• Masking Description: Results handled without knowledge of randomization group
• Primary Purpose: Supportive Care
• Official Title: Organization of the Dietetic Service in a Hospital - on the Ward or Centralized?
• Actual Study Start Date: April 18, 2015
• Actual Primary Completion Date: April 25, 2016
• Actual Study Completion Date: April 22, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Dietetic service; Nutritional assessment and therapy by dietitian throughout the hospital stay	Procedure: Nutritional assessment and therapy; Nutritional screening, nutritional plan, follow-up and instructions on discharge
Placebo Comparator: standard care; Nutritional handling by nurses supported by a dietician if needed	Procedure: Standard care; Nutritional handling by nurse

Outcome Measures

Primary Outcome Measures :

1. re-admission-rate after discharge (%) [ Time Frame: 2 months ]
   admission for the same diagnosis

Secondary Outcome Measures :

1. intake of protein during hospital stay [ Time Frame: 1 week ]
   % of estimated needs
2. intake of energy during hospital stay [ Time Frame: 1 week ]
   % of estimated needs

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• adult
• acutely admitted to hospital

Exclusion Criteria:

• dementia
• unable to comply with the protocol

Contacts and Locations

Sponsors and Collaborators

Jens Rikardt Andersen

Investigators

• Principal Investigator: Jens R Andersen; University of Copenhagen

More Information

• Responsible Party: Jens Rikardt Andersen, Associate Professor, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT03582202
• Other Study ID Numbers: H-15004856
• First Posted: July 10, 2018
• Last Update Posted: July 16, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jens Rikardt Andersen, University of Copenhagen:

dietitic service, organization of service

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders