Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000868785
Ethics application status
Approved
Date submitted
1/08/2013
Date registered
6/08/2013
Date last updated
8/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying and overcoming barriers to nutrition care in hip fracture.
Scientific title
Do hip fracture inpatients, following multidisciplinary and multimodal changes to routine clinical practice guided by a pragmatic, action research framework, when compared with the baseline routine clinical practice of individualised nutritional care, lead to improved inpatient energy and protein intakes?
Secondary ID [1] 282944 0
nil
Universal Trial Number (UTN)
U1111-1146-2532
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malnutrition 289764 0
hip fracture 289765 0
Condition category
Condition code
Diet and Nutrition 290104 290104 0 0
Other diet and nutrition disorders
Injuries and Accidents 290141 290141 0 0
Fractures
Public Health 290142 290142 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An ethics approved before and after study evaluating changes to routine clinical practice for patients admitted to an acute hip fracture inpatients unit for surgical intervention of a hip fracture. Observed and reported barriers to nutritional care were identified; improvements to routine nutritional care were then identified, developed and implemented by the treating team as part of usual service improvement practices using an action research framework.

The new multi-disciplinary, multi-modal nutritional model of care was then developed by the multidisciplinary treating team and embedded into routine clinical practice for all patients. Key improvements implemented were adopting a medicalisation of nutrition approach (medical scripting of supplements, supported medical diagnosis of malnutrition and patient education, consideration of whether enteral tube feeding was considered in the patients best interest), a coordinated multidisciplinary approach including delegation of activities to nutrition assistant staff, enhancements to the hospital foodservice system, and multimodal strategies to improve staff and patient knowledge and awareness. These changes were then evaluated using the same measures conducted during the first phase.

The duration of assessment of the model of care changes was over two 10 week periods; however the total duration of data collection for the entire multiphase study including identification of barriers to intake was conducted from September 2011-July 2012. Pragmatic outcomes measures were only included that were collected as part of routine clinical practice audit; nil additional measures or interventions apart from those applied as changes to routine clinical practice were undertaken. Strategies used to monitor adherance were not applicable in response to the pragmatic trial design.
Intervention code [1] 287648 0
Treatment: Other
Comparator / control treatment
Comparator recruitment occurred between April and July 2012 for randomly selected patients admitted to the same dedicated orthogeriatric unit located within a metropolitan teaching hospital with a diagnosis of fractured neck of femur requiring surgical intervention. Standard treatment was applied with all patients placed on a high protein, appropriately textured diet from admission and nutritionally at risk/malnourished patients received individualised nutrition care in line with routine clinical practice. Qualitative and quantitative data was collected between September 2011 and July 2012 to identify barriers to nutrition from the same source.
Control group
Historical

Outcomes
Primary outcome [1] 290143 0
Primary outcome: group mean energy (kJ, kJ/kg(ABW)) and protein (g, g/kg(ABW)) intake as assessed using 24 hour weighed food records.
Timepoint [1] 290143 0
3 inpatients were randomly selected every fourth day after commencement of data collection with a target sample size of 60 x 24 hour weighed food records collected over a 10 week period for both the standard treatment group and the 'post implemenation of changes to routine clinical practice' group. Data was collected between April - June 2012 and July - September 2012.
Secondary outcome [1] 304010 0
Malnutrition inpatient incidence or deterioration in malnutrition status as measured using internationally validated nutritional assessment criteria; the primary criteria used were the International Classification for Diseases Version 10 Australian Modification classifications for protein-energy malnutrition (E43, E44.0, E44.1).
Timepoint [1] 304010 0
Malnutrition status collected on admission and at discharge for 2 x 10 week data collection periods as above.
Secondary outcome [2] 304011 0
Discharge destination from the unit
Timepoint [2] 304011 0
Individual patient discharge destination was collected at time of discharge for all patients.
Secondary outcome [3] 304012 0
Nutrition screening tool performance in patients admitted to a hip fracture unit including sensitivity, specificity, positive and negative predictive values. Tools included the Mini-Nutritional Assessment Short Form, the Malnutrition Universal Screening Tool, the Malnutrition Screening Tool, and the Nutrition Risk Screen 2002.
Timepoint [3] 304012 0
Nutrition screening and diagnostic data was collected for inpatients over a 6 month period between September 2011 and March 2012

Eligibility
Key inclusion criteria
Inclusion criteria were patients admitted to an orthogeriatric
unit of a publically funded metropolitan hospital with a fractured neck of femur requiring surgical intervention.
Minimum age
No limit
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This pre / post study examined changes to routine clinical practice. A random selection of patients admitted to a hip fracture unit for surgical intervention had observational data recorded as part of an audit of routine clinical practice (n=60 baseline data). Changes to routine clinical practice were then made by the treating team. Following embedding of the new model of care, a random selection of patients (n=60) admitted to a hip fracture unit for surgical intervention had the same observational data recorded as part of an audit of routine clinical practice for comparative purposes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
pre-post comparative study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined using a two sided, two sample means to identify an alternate difference in group means of 25kJ/kg between groups, assuming a standard deviation within groups of 45kJ/kg using a power of 0.8. Pearson’s chi-squared or Fisher’s exact tests were used to investigate relationships between categorical data and independent sample t-tests or equivalent non-parametric t-tests were applied for continuous variables. Binomial logistic regression was used to assess the ability of the intervention to predict improvements in patient outcomes identified using bivariate analysis whilst allowing for confounding variables. Statistical significance was determined using a p-value of < 0.05. A statistician was consulted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/09/2011
Actual
6/09/2011
Date of last participant enrolment
Anticipated
30/09/2012
Actual
3/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1371 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 7232 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 287719 0
Charities/Societies/Foundations
Name [1] 287719 0
The Prince Charles Hospital Foundation
Country [1] 287719 0
Australia
Primary sponsor type
Individual
Name
Jack Bell
Address
Nutrition and Dietetics
The Prince Charles Hospital
Rode Road
Chermside Qld 4032
Country
Australia
Secondary sponsor category [1] 286449 0
None
Name [1] 286449 0
Address [1] 286449 0
Country [1] 286449 0
Other collaborator category [1] 277561 0
University
Name [1] 277561 0
Centre for Dietetics Research
School of Human Movement Studies
The University of Queensland
Address [1] 277561 0
Centre for Dietetics Research, School of Human Movement Studies
The University of Queensland
St Lucia, Qld, 4072
Country [1] 277561 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289674 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 289674 0
Ethics committee country [1] 289674 0
Australia
Date submitted for ethics approval [1] 289674 0
Approval date [1] 289674 0
07/06/2011
Ethics approval number [1] 289674 0
HREC/11/QPCH/90
Ethics committee name [2] 289675 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [2] 289675 0
Ethics committee country [2] 289675 0
Australia
Date submitted for ethics approval [2] 289675 0
Approval date [2] 289675 0
01/05/2012
Ethics approval number [2] 289675 0
HREC12/QPCH/83
Ethics committee name [3] 289676 0
HMS Ethics Committee, University of Queensland
Ethics committee address [3] 289676 0
Ethics committee country [3] 289676 0
Australia
Date submitted for ethics approval [3] 289676 0
Approval date [3] 289676 0
06/07/2011
Ethics approval number [3] 289676 0
HMS11/0607
Ethics committee name [4] 289677 0
HMS Ethics Committee, The University of Queensland
Ethics committee address [4] 289677 0
Ethics committee country [4] 289677 0
Australia
Date submitted for ethics approval [4] 289677 0
Approval date [4] 289677 0
04/09/2012
Ethics approval number [4] 289677 0
HMS12/0904

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

Contacts
Principal investigator
Name 41902 0
Mr Jack J. Bell
Address 41902 0
Nutrition and Dietetics
The Prince Charles Hospital
Rode Road
Chermside, Qld, 4032
Country 41902 0
Australia
Phone 41902 0
+61 7 3139 5589
Fax 41902 0
Email 41902 0
[email protected]
Contact person for public queries
Name 41903 0
Jack J. Bell
Address 41903 0
Nutrition and Dietetics
The Prince Charles Hospital
Rode Road
Chermside, Qld, 4032
Country 41903 0
Australia
Phone 41903 0
+61 7 3139 5589
Fax 41903 0
Email 41903 0
[email protected]
Contact person for scientific queries
Name 41904 0
Jack J. Bell
Address 41904 0
Nutrition and Dietetics
The Prince Charles Hospital
Rode Road
Chermside, Qld, 4032
Country 41904 0
Australia
Phone 41904 0
+61 7 3139 5589
Fax 41904 0
Email 41904 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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