Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000525280
Ethics application status
Approved
Date submitted
23/06/2009
Date registered
1/07/2009
Date last updated
17/02/2020
Date data sharing statement initially provided
17/02/2020
Date results information initially provided
17/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Encouraging, Assisting and Time to EAT: Comparison of mealtime assistance interventions in elderly medical inpatients
Scientific title
Encouraging, Assisting and Time to EAT: Comparison of mealtime assistance interventions in elderly medical inpatients
Secondary ID [1] 280517 0
Nil
Secondary ID [2] 300569 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition in hospitalised older adults 237085 0
Condition category
Condition code
Diet and Nutrition 237408 237408 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 feeding assistance models across 3 internal medicine wards. Each will run for a duration of 3 months (with 2 weeks lead in time prior to collecting data):
1. additional assistant-in-nursing (AIN) to assist with nutrition intake and care: 1 additional AIN per ward (existing 10 nurses per ward) with nutrition specific-role to feed patients, set up, fill in menus, liaise with dietitian and speech pathologist etc.
2. team-based nutrition care including protected meal times: education of multidisciplinary team (allied health, nursing and medical) to encourage and assist nutritional intake and observe protected meal times (limit non-urgent interruptions to patients at mealtimes)
3. additional AIN introduced to ward with team-based model
Intervention code [1] 236805 0
Treatment: Other
Comparator / control treatment
Usual care (nutritional care model centres around nutrition and dietetics staff with lack of responsibility for nutritional care by other staff)
Control group
Historical

Outcomes
Primary outcome [1] 238213 0
Energy intake - 24hr dietary intake assessed by direct observation and plate waste methods, Foodworks software and known nutritional composition of standard serving sizes will be used to calculate energy intake.
Timepoint [1] 238213 0
24hr dietary intake data on day 4 of admission
Secondary outcome [1] 244526 0
Protein intake - 24hr dietary intake assessed by direct observation and plate waste methods, Foodworks software and known nutritional composition of standard serving sizes will be used to calculate protein intake.
Timepoint [1] 244526 0
24hr dietary intake data on day 4 of admission

Eligibility
Key inclusion criteria
65 years or older
Admitted to Internal Medicine study wards
Expected length of stay >3 days
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative or terminal intent of admission
Expected length of stay <3 days
Transferred to another hospital ward/ treating team

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients are admitted to study wards based on the existing centralised bed allocation system. This pseudorandmisation has been shown to effectively match groups for chacteristics and outcomes in other studies on these wards.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
30/06/2009
Date of last data collection
Anticipated
Actual
30/06/2009
Sample size
Target
120
Accrual to date
Final
141
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1813 0
4029

Funding & Sponsors
Funding source category [1] 237197 0
Hospital
Name [1] 237197 0
Queensland Health Strengthening Aged Care
Country [1] 237197 0
Australia
Funding source category [2] 237198 0
Charities/Societies/Foundations
Name [2] 237198 0
Royal Brisbane Women's Hospital Research Foundation
Country [2] 237198 0
Australia
Funding source category [3] 237199 0
Hospital
Name [3] 237199 0
QH Health Practitioner Research Scheme
Country [3] 237199 0
Australia
Primary sponsor type
Individual
Name
Adrienne Young
Address
Department of Nutrition and Dietetics
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country
Australia
Secondary sponsor category [1] 4693 0
Individual
Name [1] 4693 0
Merrilyn Banks
Address [1] 4693 0
Department of Nutrition and Dietetics
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country [1] 4693 0
Australia
Other collaborator category [1] 715 0
Individual
Name [1] 715 0
Alison Mudge
Address [1] 715 0
Department of Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country [1] 715 0
Australia
Other collaborator category [2] 716 0
Individual
Name [2] 716 0
Lynda Ross
Address [2] 716 0
Department of Nutrition and Dietetics
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country [2] 716 0
Australia
Other collaborator category [3] 717 0
Individual
Name [3] 717 0
Lynne Daniels
Address [3] 717 0
Institute of Health and Biomedical Innovation
QUT, Kelvin Grove campus
GPO Box 2434
Brisbane Qld 4001
Country [3] 717 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239293 0
RBWH
Ethics committee address [1] 239293 0
Royal Brisbane and Women's Hospital
Herston Qld 4029
Ethics committee country [1] 239293 0
Australia
Date submitted for ethics approval [1] 239293 0
Approval date [1] 239293 0
22/12/2008
Ethics approval number [1] 239293 0
HREC/OS/QRBW/25
Ethics committee name [2] 239294 0
Queensland University of Technology
Ethics committee address [2] 239294 0
GPO Box 2434
Brisbane Qld 4001
Ethics committee country [2] 239294 0
Australia
Date submitted for ethics approval [2] 239294 0
Approval date [2] 239294 0
21/01/2009
Ethics approval number [2] 239294 0
0900000036

Summary
Brief summary
This intervention trial is a pragmatic study to investigate the impact of three feeding assistance models on energy intake of older hospitalised patients (compared with pre-intervention data) and will provide some pilot data for other clinical outcomes, such as functional capacity, length of stay and mortality. This study will add to the limited evidence base on interventions to improve nutritional intake in elderly hospital patients. While this study will not be adequately powered to determine whether clinical outcomes are improved with these interventions, findings could be used to inform the design of larger trials to further evaluate outcomes such as functional status, hospital readmission and mortality.

This study will also explore the impact of the different feeding assistance models on ward culture. As implementation of these interventions will require complex changes to service delivery, it is imperative that changes in staff behaviours and their perspective and acceptability of interventions are explored.
Trial website
Trial related presentations / publications
Young AM, Mudge AM, Banks MD, Ross LJ, Daniels L. Encouraging, assisting and time to EAT: improved nutritional intake for older medical patients receiving Protected Mealtimes and/or additional nursing feeding assistance. Clin Nutr. 2013;32(4):543-9.
Public notes

Contacts
Principal investigator
Name 29791 0
Dr Adrienne Young
Address 29791 0
Department of Nutrition and Dietetics Royal Brisbane and Women's Hospital Herston Qld 4029
Country 29791 0
Australia
Phone 29791 0
+61 7 36467997
Fax 29791 0
Email 29791 0
[email protected]
Contact person for public queries
Name 13038 0
Dr Adrienne Young
Address 13038 0
Department of Nutrition and Dietetics
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country 13038 0
Australia
Phone 13038 0
+61 7 3636 7997
Fax 13038 0
Email 13038 0
[email protected]
Contact person for scientific queries
Name 3966 0
Dr Adrienne Young
Address 3966 0
Department of Nutrition and Dietetics
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country 3966 0
Australia
Phone 3966 0
+61 7 3636 7997
Fax 3966 0
Email 3966 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
Not covered under ethics approval


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Young AM, Mudge AM, Banks MD, Ross LJ, Daniels L. ... [More Details]

Documents added automatically
No additional documents have been identified.