Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000342112
Ethics application status
Not required
Date submitted
13/02/2019
Date registered
5/03/2019
Date last updated
5/03/2019
Date data sharing statement initially provided
5/03/2019
Date results information initially provided
5/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The health implications of malnutrition in Northern New South Wales
Scientific title
To observe the prevalence of malnutrition in adult patients admitted to northern NSW hospitals and whether their nutrition status was associated with increased length of stay in hospital, readmissions rates and in-hospital mortality compared to well-nourished patients
Secondary ID [1] 297395 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malnutrition 311548 0
falls 311549 0
infection 311550 0
mortality 311551 0
Condition category
Condition code
Diet and Nutrition 310188 310188 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Newly admitted patients were assessed for nutrition status in 2014. The audit was performed using the Subjective Goal Assessment tool, a validated tool for assessing malnutrition in the hospital setting. Retrospectively, conditions observed from medical records documents during their admission include: length of stay in hospital, mortality in hospital, hospital readmissions, falls in hospital, falls in subsequent admissions, infections, pressure wounds. The data was collected retrospectively between July 2018 and January 2019. Only the hospital patient data is being used for this study
Intervention code [1] 313651 0
Early Detection / Screening
Comparator / control treatment
patients who are well nourished determined using a validated nutrition assessment tool
Control group
Active

Outcomes
Primary outcome [1] 319073 0
length of stay in hospital determined by counting the number of days from the date they are admitted until the day they are discharged. This data is pulled from hospital medical records.
Timepoint [1] 319073 0
The date of admission, determined from hospital medical records, that was the admission when the nutrition audit was conducted.
Primary outcome [2] 319074 0
in hospital mortality determined from hospital medical records and subsequent admissions to hospital that have indicated when the patient has become deceased in hospital.
Timepoint [2] 319074 0
In hospital mortality will be noted from the first admission (when the nutrition assessment was conducted) and in subsequent admissions following (if any).
Primary outcome [3] 319075 0
hospital readmissions, determined from hospital medical records, will be recorded post the initial hospital admission when the nutrition assessment was conducted
Timepoint [3] 319075 0
within 3 months of the first admission when the nutrition assessment was made
Secondary outcome [1] 366911 0
falls, noted from hospital medical records. Indicated by an incident note in the progress notes, discharge summary or entry by nursing staff into progress notes
Timepoint [1] 366911 0
This will be noted by looking through hospital medical records to determine if the patient has experienced a fall within the first admission when the nutrition assessment was made or in subsequent admissions,
Secondary outcome [2] 366912 0
Whether the patient has had an infection during the initial admission when the nutrition assessment was conducted. This will be identified through hospital medical records by noting if infection was the reason for admission, or reading progress notes to determine whether an infection has been obtained during admission, or reading medical team entries that identify whether infection is a cause of their admission.
Timepoint [2] 366912 0
During the days of initial admission when the nutrition assessment was made.
Secondary outcome [3] 366913 0
Pressure woumds, determined from reading hospital medical records. Staff including nurses and doctors may indicate a pressure wound by making an entry in the progress notes, may also be in the discharge summary
Timepoint [3] 366913 0
during any of the admission days when the nutrition assessment was conducted

Eligibility
Key inclusion criteria
adult patients admitted to the medical, surgical and rehabilitation wards of Tweed, Murwillumbah, Mullumbimby and Byron Bay hospitals.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
children, pregnant patients, patients admitted to wards other than those specified

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Data analysis was completed using IBM SPSS Statistics 25. The point-prevalence of malnutrition was reported using the three ratings of the SGA and malnutrition dichotomously (well-nourished/SGA rating A; or malnourished/SGA ratings B and C). For continuous outcomes (LOS, age, others…), Shapiro Wilk was used to test normality. Continuous variables are presented with mean (SD), and median (IQR) was used to report non-parametric variables. The Chi-squared test or independent t-tests (or Mann Whitney U test for non-parametric variables) were used to test associations of outcome variables with nutrition status (well-nourished/SGA rating A; or malnourished/SGA ratings B and C). Statistical significance was considered at the P<0.05 level two tailed, 95% confidence interval.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/12/2018
Date of last participant enrolment
Anticipated
Actual
4/02/2019
Date of last data collection
Anticipated
Actual
4/02/2019
Sample size
Target
130
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13131 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [2] 13132 0
Murwillumbah District Hospital - Murwillumbah
Recruitment hospital [3] 13133 0
Byron District Hospital - Byron Bay
Recruitment hospital [4] 13134 0
Mullumbimby & District War Memorial Hospital - Mullumbimby
Recruitment postcode(s) [1] 25672 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 25673 0
2484 - Murwillumbah
Recruitment postcode(s) [3] 25674 0
2481 - Byron Bay
Recruitment postcode(s) [4] 25675 0
2482 - Mullumbimby

Funding & Sponsors
Funding source category [1] 301968 0
University
Name [1] 301968 0
Bond University
Country [1] 301968 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Dr, Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 301739 0
None
Name [1] 301739 0
Address [1] 301739 0
Country [1] 301739 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 302647 0
Ethics committee address [1] 302647 0
Ethics committee country [1] 302647 0
Date submitted for ethics approval [1] 302647 0
Approval date [1] 302647 0
Ethics approval number [1] 302647 0

Summary
Brief summary
The purpose of the study is to report malnutrition prevalence from the nutrition audit conducted in 2014 and whether certain outcomes demonstrate an association to the determined nutrition status. Understanding whether malnutrition is linked to outcomes including length of stay in hospital, readmission, infections and falls can help identify where improvements in medical care is required. Based on previous findings in the literature, the hypothesis is that malnourished and severely malnourished patients experience longer number of days in hospital, are at an increased risk of having falls, infections and in-hospital mortality.
Trial website
Trial related presentations / publications
Public notes
Project is considered a quality assurance project and therefore ethics approval was not needed, as determined by ethics committee

Contacts
Principal investigator
Name 90922 0
Ms Eloisa Lopez
Address 90922 0
Unit 12a, 1 University Drive Robina, QLD 4226. Bond University
Country 90922 0
Australia
Phone 90922 0
+61 402927372
Fax 90922 0
Email 90922 0
[email protected]
Contact person for public queries
Name 90923 0
Ms Eloisa Lopez
Address 90923 0
Unit 12a, 1 University Drive Robina, QLD 4226. Bond University
Country 90923 0
Australia
Phone 90923 0
+61 402927372
Fax 90923 0
Email 90923 0
[email protected]
Contact person for scientific queries
Name 90924 0
Ms Eloisa Lopez
Address 90924 0
Unit 12a, 1 University Drive Robina, QLD 4226. Bond University
Country 90924 0
Australia
Phone 90924 0
+61 402927372
Fax 90924 0
Email 90924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.