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Trial registered on ANZCTR


Registration number
ACTRN12613000318785
Ethics application status
Approved
Date submitted
17/03/2013
Date registered
21/03/2013
Date last updated
21/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Can the use of a rapid nutrition screening tool facilitate timely dietetic referrals on the acute renal wards? – A validation study
Scientific title
Can the use of a rapid nutrition screening tool facilitate timely dietetic referrals on the acute renal wards? – A validation study
Secondary ID [1] 282124 0
Nil Known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition screening 288620 0
Kidney disease 288657 0
Condition category
Condition code
Diet and Nutrition 288952 288952 0 0
Other diet and nutrition disorders
Renal and Urogenital 288999 288999 0 0
Kidney disease
Public Health 289000 289000 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study uses a prospective blind comparison to a gold standard study design. It will take place in the acute renal ward in Middlemore Hospital, Auckland, New Zealand. Consenting patients (n=229) admitted to the ward will be recruited over a period of eight weeks. The undernutrition risk of each renal inpatient identified by the newly developed nutrition screening tool will be compared with their nutrition status assessed using the subjective global assessment and hand grip strength for validity. In the ward setting, the number and accuracy of dietetic referrals will be measured before and after implementation of the proposed tool. The newly developed screening tool is divided into two parts with nine questions regarding to weight loss in the past 30 days, appetite, oral intake and biochemical markers. Part one contains five compulsory questions. If a patient scores three or more in part one, a dietetic referral is generated. This means that this patient may be at risk of undernutrition requiring dietetic interventions. If a patient scores less than three in part one, part two consisting of four additional questions should be completed. If the total score of both part one and part two is three or more, a referral will be generated. The gold standard is aimed at providing a full nutrition assessment, ideally requiring significant dietetic input. However, the proposed tool is designed to be quick and easy so that it can be administered and completed by the nursing staff in approximately five minutes within 48 hours of admission.
Intervention code [1] 286729 0
Early detection / Screening
Comparator / control treatment
This study is investigating the reliability and validity of a screening tool by assessing inter-rater reliability and construct validity. There is no undernutrition screening currently operating on the ward level. However, the current standard dietetic referral practices in the acute renal ward are self dietetic referrals by the patients, oral or written referrals by the ward nursing staff, or direct referrals by the ward dietitians.
Control group
Active

Outcomes
Primary outcome [1] 289080 0
TThe effectiveness of this proposed nutrition screening tool in recognising renal inpatients at risk of undernutrition in comparison with undernutrition assessments. Subjective global assessment and hand grip results will be used as the gold standard for assessing the sensitivity and specificity of the screening tool. Area under the receiver operating characteristic (ROC) curve, sensitivity and specificity, positive predictive value and negative predictive value and their 95% confidence intervals will be summarised. Multiple logistic regression models will be used to correlate results from the screening tool against the gold standard results, adjusted by patients’ characteristics.
Timepoint [1] 289080 0
After the implementation of the tool on the ward level over a period of eight weeks or until the number of participants reaches 229.
Secondary outcome [1] 301710 0
The acceptability of the newly developed screening tool as a standard practice by nursing staff on the renal ward using a qualitative survey with open ended questions.
Timepoint [1] 301710 0
After the implementation of the tool on ward level at the end of the eight week period.

Eligibility
Key inclusion criteria
Inclusion criteria: any patients admitted on Ward one due to acute kidney injury, chronic renal failure, and established renal failure (on haemodialysis, peritoneal dialysis or transplant).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: patients with learning disabilities, mental illness, dementia, terminal illness, being unconscious, emergency situations, and inability to consent for themselves.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients admitted into the ward will have a chance to participate in the study (i.e. all cultural, religious, social, and
ethnic groups will be included). All study participants will receive two types of nutrition screening, whereby the effectiveness of the proposed screening tool will only be compared to the gold standard.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
229
Accrual to date
Final
Recruitment outside Australia
Country [1] 4932 0
New Zealand
State/province [1] 4932 0
Auckland

Funding & Sponsors
Funding source category [1] 286892 0
University
Name [1] 286892 0
Massey University
Country [1] 286892 0
New Zealand
Primary sponsor type
University
Name
Institute of Food Nutrition and Human Health, Massey University
Address
Institute of Food Nutrition and Human Health
Massey University
Eastbourne Rd
Building 22
Gate 4
Oteha Rohe Campus
Albany
Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 285692 0
None
Name [1] 285692 0
Address [1] 285692 0
Country [1] 285692 0
Other collaborator category [1] 277322 0
Hospital
Name [1] 277322 0
Counties Manukau District Health Board
Address [1] 277322 0
Nutrition services,
Middlemore Hospital
Private bag 93311
Otahuhu
Auckland 1062
Country [1] 277322 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288954 0
Northen A Health and Disability Ethics Committee
Ethics committee address [1] 288954 0
Ethics committee country [1] 288954 0
New Zealand
Date submitted for ethics approval [1] 288954 0
Approval date [1] 288954 0
17/01/2013
Ethics approval number [1] 288954 0
13/NTA/1

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

Contacts
Principal investigator
Name 38486 0
Mr Andrew Xia
Address 38486 0
Private Bag 102 904
Institute of Food, Nutrition and Human Health
Massey University
Auckland 0745
Country 38486 0
New Zealand
Phone 38486 0
+6421887730
Fax 38486 0
Email 38486 0
y.xia@massey.ac.nz
Contact person for public queries
Name 38487 0
Andrew Xia
Address 38487 0
Private Bag 102 904
Institute of Food, Nutrition and Human Health
Massey University
Auckland 0745
Country 38487 0
New Zealand
Phone 38487 0
+6421887730
Fax 38487 0
Email 38487 0
y.xia@massey.ac.nz
Contact person for scientific queries
Name 38488 0
Andrew Xia
Address 38488 0
Private Bag 102 904
Institute of Food, Nutrition and Human Health
Massey University
Auckland 0745
Country 38488 0
New Zealand
Phone 38488 0
+6421887730
Fax 38488 0
Email 38488 0
y.xia@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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.