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Trial registered on ANZCTR


Registration number
ACTRN12613000154707
Ethics application status
Not yet submitted
Date submitted
7/02/2013
Date registered
8/02/2013
Date last updated
8/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Early Assessment of Malnutrition in Hospitalised Patients; Prealbumin versus Routine Clinical Assessment
Scientific title
Improving Early Assessment of Malnutrition in Hospitalised Patients; Prealbumin versus Routine Clinical Assessment
Secondary ID [1] 281837 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition screening 288195 0
Condition category
Condition code
Diet and Nutrition 288565 288565 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this research is to investigate whether the introduction of Prealbumin (PAB) screening within the hospital setting will improve identification of malnourished patients compared to current assessment of malnutrition.
Routine clinical assessment: The Malnutrition Universal Screening Tool (MUST) was implemented into admission documentation at Waitakere and North Shore Hospitals in 2006. Various other clinical assessment practises for malnutrition still continue, but are not formalised into the patient care pathway.
Methodological Procedures:
The study will be conducted in two phases. The first observing routine clinical care, the second observing results of introducing the obligatory laboratory test.
The standard clinical documentation has the MUST score as part of the Admission-to-Discharge Planner card, which is completed at first by the admitting doctor. Once transferred to the ward the nursing process should involve the completion of a second MUST score sheet. A score of 2 or more should generate a referral, which can be by any clinician, to the Nutrition Services for a formal nutritional assessment. Each ward has its own allocated Dietitian based there, and they use the PG-SGA to assess malnutrition.Through out the study the ward dietitians will record the following data set:
NHI number; date admitted, ward, date referred to nutrition services, who referred, what screening tool triggered referral (MUST, PAB or other); MUST score, PAB level, Patient Guided Subjective Global Assessment (PG-SGA) score; subjective assessment as whether malnourished or not; degree of malnutrition (subjective) Mild/moderate/severe; whether discharged before being seen.
Phase 1:No alteration will be made to routine malnutrition screening presently performed at North Shore Hospital. Patients admitted to North Shore Hospital Wards; Acute Medical 3 and 10,Acute Surgical 4 and 8, Acute Orthopaedic ward 7 over four weeks of February as baseline measure.
Phase 2:All patients who have blood tests taken on admission to North Shore Hospital routinely have their remaining plasma stored for a further 24 hours. All patients admitted to North Shore Hospital Wards; Acute Medical 3 and 10,Acute Surgical 4 and 8, Acute Orthopaedic ward 7 4th March to 3rd April.
Patients newly admitted to the test wards will be identified from the Patient Information System (PIMS). The plasma samples of these patients will be removed from storage and tested for PAB, Retinol Binding Protein and Transferrin. The PAB results will be immediately posted on the hospital patient result portal, Concerto. Abnormal results appear in red and already have the automatic message appearing on the screen when the result is opened; ”A low prealbumin may indicate a failure of hepatic synthesis as a result of malnutrition, hepatic injury or inflammation, or be due to loss of protein as in protein loosing enteropathy. A referral to the ward dietitian is appropriate".
Patients who have not had a serum albumin measured will also have that tested and displayed on Concerto.
Results of RBP and Transferrin will not be displayed on Concerto, but recorded for later analysis.
If complete blood counts have been taken lymphocyte count result will be noted, but if Complete blood count (CBC) has not been taken within the previous 24 hours extra blood will not be drawn for this.



Laboratory methods:An aliquot of plasma, from lithium heparin blood taken routinely at admission, will be stored at 4 degrees C. PAB will be clinically determined by immunoturbidimetric test at North Shore hospital. The normal reference range for prealbumin is 0.2- 0.3 g/L. Albumin normal reference range 38-52g/L 1-70 years and 36-50g/L >70 years. Transferrin reference range is 2.4-3.6 g/L.
Intervention code [1] 286397 0
Early detection / Screening
Comparator / control treatment
Control Phase: Routine clinical assessment e.g. Malnutrition Universal Screening Tool (MUST) screening will continue on hospitalised patients.
No alteration will be made to routine malnutrition screening presently performed at North Shore Hospital.
Control group
Active

Outcomes
Primary outcome [1] 288720 0
The proportion of patients identified at risk of malnutrition and referred for a nutrition assessment, before and after the introduction of Prealbumin as an obligatory test.
Timepoint [1] 288720 0
February: Phase one
Phase 2: Consecutively over a timeline of 2-3 weeks, Monday to Thursday of each week from the 4th March, 2013.
Primary outcome [2] 288812 0
The degree of malnutrition as measured by the PG-SGA in patients referred by routine clinical screening and by Prealbumin.
Timepoint [2] 288812 0
February: Phase one
Phase 2: Consecutively over a timeline of 2-3 weeks, Monday to Thursday of each week from the 4th March, 2013.
Secondary outcome [1] 301057 0
Comparison of sensitivity of Prealbumin, RBP, Transferrin, lymphocyte count and albumin in detecting malnutrition.
Timepoint [1] 301057 0
February: Phase one
Phase 2: Consecutively over a timeline of 2-3 weeks, Monday to Thursday of each week from the 4th March, 2013.

Eligibility
Key inclusion criteria
Inclusion criteria: all patients admitted acutely on the study days to specific study wards at North Shore Hospital, Auckland. Men and women aged 18 years+. It is anticipated that a total of 700 patients will be tested during the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment outside Australia
Country [1] 4821 0
New Zealand
State/province [1] 4821 0
Auckland

Funding & Sponsors
Funding source category [1] 286622 0
Commercial sector/Industry
Name [1] 286622 0
Siemens Ltd NZ
Country [1] 286622 0
New Zealand
Primary sponsor type
Hospital
Name
North Shore Hospital
Address
124 Shakespeare Rd, Westlake 0622
Westlake
Auckland
Country
New Zealand
Secondary sponsor category [1] 285407 0
University
Name [1] 285407 0
Massey University
Address [1] 285407 0
6 Bass Rd
Albany, Auckland
0632
Country [1] 285407 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288696 0
Health and Disability Ethics Committee
Ethics committee address [1] 288696 0
Ethics committee country [1] 288696 0
New Zealand
Date submitted for ethics approval [1] 288696 0
30/01/2013
Approval date [1] 288696 0
Ethics approval number [1] 288696 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37346 0
Mrs Tracey Eccles
Address 37346 0
136 Blackbridge Road
Dairy Flat
Auckland
New Zealand
0794
Country 37346 0
New Zealand
Phone 37346 0
+64094650565
Fax 37346 0
Email 37346 0
t.eccles@massey.ac.nz
Contact person for public queries
Name 37347 0
Tracey Eccles
Address 37347 0
136 Blackbridge Road
Dairy Flat
Auckland
New Zealand
0794
Country 37347 0
New Zealand
Phone 37347 0
+64094650565
Fax 37347 0
Email 37347 0
t.eccles@massey.ac.nz
Contact person for scientific queries
Name 37348 0
Tracey Eccles
Address 37348 0
136 Blackbridge Road
Dairy Flat
Auckland
New Zealand
0794
Country 37348 0
New Zealand
Phone 37348 0
+64094650565
Fax 37348 0
Email 37348 0
t.eccles@massey.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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