Basic Care Revisited: Early Nutrition Intervention for Outpatients
BCR_N
Basic Care Revisited: an Early Nursing Nutrition Intervention for Outpatients in Need of Surgery
1 other identifier
interventional
150
1 country
2
Brief Summary
Early nursing nutrition intervention for outpatients in need of surgery
- Objective - To investigate the feasibility and effectiveness of screening and an early nursing intervention on malnutrition in outpatients in need for surgery.
- Design - Multi-centre cluster-randomised controlled early trial design (n=150 patients)
- Intervention - Malnutrition screening (during outpatient clinic visit) and (in case of patients being ´at risk for malnutrition´ or being ´malnourished´), a nutrition care plan (including nutritional drinks and energy and protein rich meals) tailored to individual patient requirements
- Comparison - Usual care (no nutritional care plan)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMay 12, 2015
May 1, 2015
11 months
March 11, 2015
May 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in BMI
body mass index: at 3 points in time; 1) at the outpatient clinic, 2) at hospitalisation, and 3) at discharge. Average time frame for each patient is 5 weeks.
Up to 6 months
Secondary Outcomes (5)
LOS
Up to 6 months
Health related QoL
Up to 6 months
CQ satisfaction
Up to 6 months
Costs
Up to 6 months
Process
Up to 6 months
Study Arms (2)
Experimental
EXPERIMENTALThe early nursing nutrition intervention will include malnutrition screening (during outpatient clinic visit) with the MUST. If patients are ´at risk for malnutrition´ or ´malnourished´, a standardized nutrition care plan will be discussed with the patient by the nurse. This nutrition care plan will include: * Information and advice; * Examples of energy and protein rich meals; * patients will be asked to register their nutritional intake for two days at home; * after a week, the nurse will call the patients to answer questions and to give advice. This nutrition care plan will be tailored to the individual patient requirements. Furthermore, if patients are 'malnourished', a visit to the dietician is always suggested, because this is usual care.
Usual care
NO INTERVENTIONAll participants, both in the intervention group and the control group, receive usual care containing a regular visit to a nurse who will perform a malnutrition screening with the MUST (Malnutrition Universal Screening Tool). If patients are 'malnourished', a visit to the dietician is suggested.
Interventions
The early nursing nutrition intervention will include malnutrition screening (during outpatient clinic visit) with the MUST. If patients are ´at risk for malnutrition´ or ´malnourished´, a standardized nutrition care plan will be discussed with the patient by the nurse. This nutrition care plan will include: * Information and advice; * Examples of energy and protein rich meals; * patients will be asked to register their nutritional intake for two days at home; * after a week, the nurse will call the patients to answer questions and to give advice. This nutrition care plan will be tailored to the individual patient requirements. Furthermore, if patients are 'malnourished', a visit to the dietician is always suggested, because this is usual care.
Eligibility Criteria
You may qualify if:
- Patients planned for surgery within 6 weeks after the outpatient clinic visit;
- Patients with an age of 18 years or older;
- Patients with the ability to speak and read the Dutch language.
You may not qualify if:
- Hospital admission within one week after the outpatient clinic visit;
- Expected hospital admission \< 5 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Sint Maartenskliniekcollaborator
Study Sites (2)
Sint Maartenskliniek
Nijmegen, Gelderland, 6500 GM, Netherlands
Radboudumc
Nijmegen, Gelderland, 6500 HB, Netherlands
Related Publications (1)
van Noort HHJ, Witteman BJM, Vermeulen H, Huisman-de Waal G; Basic Care Revisited research group. An outpatient nursing nutritional intervention to prehabilitate undernourished patients planned for surgery: A multicentre, cluster-randomised pilot study. Clin Nutr. 2020 Aug;39(8):2420-2427. doi: 10.1016/j.clnu.2019.11.038. Epub 2019 Dec 2.
PMID: 31879076DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ria Nijhuis- van der Sanden, PhD
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2015
First Posted
May 12, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
May 12, 2015
Record last verified: 2015-05