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Trial registered on ANZCTR


Registration number
ACTRN12611000020987
Ethics application status
Approved
Date submitted
2/12/2010
Date registered
6/01/2011
Date last updated
29/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing and sustaining cultural and practice change to improve the nutritional status of patients in the acute care setting
Scientific title
The effectiveness of a composite nutritional intervention (a nutritional screening tool, the provision of food supplements at ward level, and a red tray system to identify those patients requiring help with eating and drinking) to reduce malnutrition in hospitalised adult patients.
Secondary ID [1] 253178 0
None
Universal Trial Number (UTN)
U1111-1118-3034
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 258719 0
Condition category
Condition code
Diet and Nutrition 258872 258872 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three linked interventions: (i) the introduction and use of a nutritional screening tool - MUST - Malnutrition Universal Screening Tool, (ii) the provision of food supplements at ward level, and (iii) the introduction of a red tray system to identify those patients requiring help with eating and drinking) will be introduced.
The interventions will be introduced over a two month period using a stepped wedge trial that ensures that all wards in the hospital will ultimately be included in the intervention. Varying amounts of historical control data will be recorded at all wards in the hospital prior to the introduction of the intervention.
The intervention itself will be implemented by pairs of facilitators across four steps (or groups) of six hospital wards each; there will be eight facilitators. One of the facilitatory pair will be a senior nurse from one of the six wards, the other will be a dietician from the hospital.
The two facilitators will be educated on the intervention using a 'train-the-trainer' approach and supplied with educational materials for subsequent transmission to nurses (enrolled and registered) working across the six wards in their group.
With respect to the intervention:
(i) The MUST tool is a standard tool for assessing patients at risk of malnutrition. It comprises four steps including measurement of current weight, height, weight 3-6 months ago and nutritional intaks. Staff will be trained in the use of the tool, and compliance with tool use will be recorded by reviewing patient records.
(ii) Patients identified by the MUST as being at medium or high risk of malnutrition will be offered nutritional supplements and nourishing fluids using supplies available at ward level, instituting a menu suitable for people with poor appetites to include nourishing mid-meals and ensuring access to mid meal snacks for “at risk” patients.
(iii) a red tray, jug and glass will be provided to patients requiring assistance and encouragement with meals due to inability to feed themselves to a satisfactory level, as identified by the MUST.
Intervention code [1] 257671 0
Other interventions
Comparator / control treatment
Usual hospital care
Control group
Active

Outcomes
Primary outcome [1] 259732 0
Rate of change in body mass (kg) from admission to discharge. Body mass will be measured using the same weighing machine for individual patients. Depending on patient mobility this may require a standing, sitting, bed, or sling weighing machine.
There is no expectation that this will result in an adverse event, as weighing patients should be standard practice. For frail, or heavy or immobile patients, appropriate care will be taken to ensure that patients are not harmed as a result of being weighed. This may require several staff to conduct the weighing following appropriate hospital guidelines.
Timepoint [1] 259732 0
Limited to duration of hospital visit, typically 3-7 days, can be longer
Primary outcome [2] 259884 0
Rate of change in body mass index (BMI). BMI is calculated as the mass divided by height squared (kg/m2). While changes in BMI give a more precise estimate about nutritional status than changes in body mass, it is envisaged that measurement of height will have a lower compliance rate than measurement of mass, and therefore we have made BMI the second primary outcome.
Timepoint [2] 259884 0
Limited to duration of hospital visit, typically 3-7 days, can be longer
Secondary outcome [1] 266466 0
Length of stay (days), measured by reviewing patient records on hospital records system. There are no adverse events expected through measuring this outcome.
Timepoint [1] 266466 0
Limited to duration of hospital visit, typically 3-7 days, can be longer.
Secondary outcome [2] 268763 0
Number of patient falls, as measured by the hospital's critical incident reporting system. While this outcome is in itself an adverse event, there are no adverse events expected through measuring this outcome.
Timepoint [2] 268763 0
Limited to duration of hospital visit, typically 3-7 days, can be longer.
Secondary outcome [3] 268764 0
Number of infections, as measured by a positive pathology test (blood, urine, wound, sputum) in the patient's medical record. While this outcome could represent an adverse event, there are no adverse events expected through measuring this outcome.
Timepoint [3] 268764 0
Limited to duration of hospital visit, typically 3-7 days, can be longer.
Secondary outcome [4] 268765 0
All cause mortality as recorded on the hospital records system
Timepoint [4] 268765 0
Limited to duration of hospital visit, typically 3-7 days, can be longer.
Secondary outcome [5] 268766 0
Anti-biotic use, measured as the number of prescriptions filled by the hospital pharmacy for antibiotics. Data to be provided by the hospital pharmacy. There are no adverse events expected through measuring this outcome.
Timepoint [5] 268766 0
Limited to duration of hospital visit, typically 3-7 days, can be longer.
Secondary outcome [6] 268767 0
Readmission rate, measured as the number of unplanned hospital readmissions to the same hospital within 28 days of discharge. Data measured using the hospital records system; no adverse effects anticipated.
Timepoint [6] 268767 0
Within 28 days of patient discharge.
Secondary outcome [7] 268768 0
Context of nursing care, as measured using the Alberta Context Tool (ACT). The ACT will be administered to nursing staff working in the wards pre- and post-implementation of the nutrition intervention. The ACT provides insight into the culture, leadership, feedback processes, structural and electronic processes and "slack" within the organisation to promote a positive context for successfully implementing evidence into practice. There are no adverse events expected through measuring this outcome.
Timepoint [7] 268768 0
1 month prior to implementing the intervention.
4 months post implementing the intervetnion.
Secondary outcome [8] 268769 0
% compliance with use of MUST nutritional screening tool, as measured through medical record review of a sample of patients. There are no adverse events expected through measuring this outcome.
Timepoint [8] 268769 0
Measured at all sites at weekly intervals pre-, during, and post-intervention.
Secondary outcome [9] 268770 0
% compliance with use of additional nutritional supplements as measured through medical record review of a sample of patients. There are no adverse events expected through measuring this outcome.
Timepoint [9] 268770 0
Measured at all sites at weekly intervals pre-, during, and post-intervention.
Secondary outcome [10] 268771 0
% compliance with use of red trays, as measured through medical record review of a sample of patients. There are no adverse events expected through measuring this outcome.
Timepoint [10] 268771 0
Measured at all sites at weekly intervals pre-, during, and post-intervention.
Secondary outcome [11] 268772 0
% compliance with documentation by nurses of patient's foods and fluids intake as measured through medical record review of a sample of patients. There are no adverse events expected through measuring this outcome.
Timepoint [11] 268772 0
Measured at all sites at weekly intervals pre-, during, and post-intervention.

Eligibility
Key inclusion criteria
Patients:
Adults (greater than or equal to 18 years)
Admitted to general hospital wards

Nursing:
All members of nursing staff
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients:
Intensive care unit patients
Cardiac recovery patients

Nursing:
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The design is a stepped wedge cluster randomised trial.
The unit of randomisation is the ward of the hospital.
There are 24 wards in the hospital that will be randomised to four groups (or steps); therefore there will be 6 wards per group.
The wards will be randomised to each of the four groups. However, there are four nursing staff that will facilitate the implementation of the intervention across each of the four groups. The wards at which each of these facilitators works at will be assigned to a different group to ensure that each of the facilitator's ward is included in the group that they are facilitating. Therefore the facilitators' wards will be stratified to each of the four groups. The stratification will be randomised.
Allocation will be conducted using central randomisation (computer software) by an off-site third party (Data Management & Analysis Centre (DMAC)).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation process will be undertaken by an independent statistician at the Data Management & Analysis Centre (DMAC), Discipline of Public Health, University of Adelaide, using Stata software.
DMAC will be provided with a list of 24 wards, identifying the four wards that are to be stratified to each group.
It is not possible to conceal the allocation of wards to the four groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The stepped wedge design is a form of crossover trial; insetad of each arm crossing from one treatment to another, each arm crosses from being a control site to being a treatment site, however, the timing varies for the four different groups.
For example, prior to the implementation (Time 0), data is collected from each ward in each group. At this stage all this data is control data. At the next time period (Time 1), the intervention is implemented at all wards in group 1, and data is, again, collected from all wards in all groups. At the next time period (Time 2), the intervention is implemented at all wards in group 2, and data is collected from all wards in all groups. This pattern continues until the intervention is implemented across all four groups. At the conclusion of the trial, all wards have received the intervention and have a varying amount of historical data with which comparisons are possible. Comparison is also possible against control sites which have not yet had the intervention.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258146 0
Hospital
Name [1] 258146 0
Royal Adelaide Hospital Research Fund
Country [1] 258146 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Discipline of Nursing
University of Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 257313 0
None
Name [1] 257313 0
Address [1] 257313 0
Country [1] 257313 0
Other collaborator category [1] 251689 0
Charities/Societies/Foundations
Name [1] 251689 0
Australian Patient Safety Foundation
Address [1] 251689 0
Playford Building
City East Campus
University of South Australia
Adelaide
SA 5000
Country [1] 251689 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260125 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 260125 0
Ethics committee country [1] 260125 0
Australia
Date submitted for ethics approval [1] 260125 0
16/11/2010
Approval date [1] 260125 0
Ethics approval number [1] 260125 0
Ethics committee name [2] 260157 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [2] 260157 0
Ethics committee country [2] 260157 0
Australia
Date submitted for ethics approval [2] 260157 0
Approval date [2] 260157 0
22/11/2010
Ethics approval number [2] 260157 0
101110

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

Contacts
Principal investigator
Name 31958 0
Address 31958 0
Country 31958 0
Phone 31958 0
Fax 31958 0
Email 31958 0
Contact person for public queries
Name 15205 0
Alison Kitson
Address 15205 0
Discipline of Nursing
University of Adelaide
SA 5005
Country 15205 0
Australia
Phone 15205 0
61 8 8313 0558
Fax 15205 0
61 8 8303 3594
Email 15205 0
[email protected]
Contact person for scientific queries
Name 6133 0
Alison Kitson
Address 6133 0
Discipline of Nursing
University of Adelaide
SA 5005
Country 6133 0
Australia
Phone 6133 0
61 8 8313 0558
Fax 6133 0
61 8 8303 3594
Email 6133 0
[email protected]

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

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