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Trial registered on ANZCTR


Registration number
ACTRN12614001316695
Ethics application status
Approved
Date submitted
27/11/2014
Date registered
16/12/2014
Date last updated
20/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Overcoming barriers to protected mealtimes implementation to prevent and treat malnutrition
Scientific title
The effect on nutritional intake of implementing a protected mealtimes strategy compared with usual practice in adults admitted to subacute care
Secondary ID [1] 285750 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition in subacute care 293637 0
Condition category
Condition code
Diet and Nutrition 293933 293933 0 0
Other diet and nutrition disorders
Public Health 293969 293969 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Protected mealtimes aims to protect mealtimes from unnecessary and avoidable interruptions, through providing a supportive environment for eating. It supports staff to provide patients with support and assistance with meals, and is therefore a systems approach to address the vast problem of in-hospital malnutrition.

This study will compare the implementation of a protected mealtimes intervention with usual care in the subacute setting. The study aims to positively improve food intake at mealtimes, therefore treating and preventing malnutrition developing. The implementation will have three steps:
1. Pre-implementation - decreasing barriers to implementation through engagement of key stakeholders, staff training, planning the implementation etc. The study has support from the Eastern Health Executive team, with the absence of support throughout the organisation known as a barrier from previous studies of protected mealtimes. The study will fall under the auspices of the Nutrition Expert Advisory Committee.
Senior staff training and engagement will commence in July 2015. Training of nursing staff and other treating team members will occur in the week prior to the intervention so as not to affect baseline data collection. There will be three group training sessions on each ward during this pre-intervention week, all administered by the lead researcher. These training sessions will be multidisciplinary.
The study will run for four weeks, including one week of baseline data collection (usual care) then the intervention introduced in one ward per week.
2. Implementation of protected mealtimes through the planned study design
Protected mealtimes will be implemented consistent with the British Caterer's Association Protected Mealtimes Policy 2004, available at: www.hospitalcaterers.org/documents/pmd.pdf
The intervention period will be 1-3 weeks.
3. Evaluation of the intervention will be two fold - compliance with the protected mealtimes implementation will be evaluated by the dietetic team who will assess compliance using the checklist from Hickson M, Connolly A, Whelan K. Impact of protected mealtimes on ward mealtime environment, patient experience and nutrient intake in hospitalised patients. J Hum Nut Diet 2011; 24:370-374.
Further, the nutritional intake of patients will be evaluated using the nutritional analysis software, Foodworks.
Intervention code [1] 290712 0
Treatment: Other
Comparator / control treatment
The study design is a cluster randomised trial, whereby all clusters (wards) will commence the study simultaneously. The order and location of the interventions will randomized using a computer generated random number sequence. Subacute wards on multiple sites will be utilised to support the stepped wedge study design.
Through utilisation of this study design, participants will form their own controls.
Control group
Active

Outcomes
Primary outcome [1] 293705 0
Energy (kJ) intake. This will be determined by Monash University dietetic students observing plate waste of individual patients across a 24 hour period during their admission. The primary researcher will conduct the nutritional analysis using the nutritional database Foodworks.
Timepoint [1] 293705 0
The duration of outcome assessment is until the study period ends (4 weeks), or until the patient is discharged (whichever is sooner).
Primary outcome [2] 293743 0
Protein (g) intake. This will be determined by Monash University dietetic students observing plate waste of individual patients across a 24 hour period during their admission. The primary researcher will conduct the nutritional analysis using the nutritional database Foodworks.
Timepoint [2] 293743 0
Intake observations will occur until the study period ends (4 weeks), or the patient is discharged (whichever is sooner)
Secondary outcome [1] 311643 0
Effectiveness of the protected mealtimes implementation. This will be monitored by Eastern Health dietitians during the study period through use of the checklists of: Hickson M, Connolly A, Whelan K. Impact of protected mealtimes on ward mealtime environment, patient experience and nutrient intake in hospitalised patients. J Hum Nut Diet 2011; 24:370-374.
Timepoint [1] 311643 0
Entire study period (4 weeks)
Secondary outcome [2] 311725 0
Handgrip strength is an indicator of muscle function and protein status. This will be measured by researchers at the bedside within 24 hours of the malnutrition assessment with a Jamar (Registered trademark) Plus + Hand Dynamometer. The measurement will be taken with the patient sitting upright in a chair or bed with the elbow flexed at 90 degrees, the forearm neutrally positioned and the wrists dorsi-flexed at 30 degrees as recommended by the American Society of Hand Therapists (ASHT). Using the non-dominant hand, three measurements will be taken and the mean value will be calculated.
Timepoint [2] 311725 0
Handgrip strength will be assessed within 24 hours of the malnutrition assessment.
Secondary outcome [3] 311726 0
Functional Independence Measure
Timepoint [3] 311726 0
These will be collected from the medical record of participants, at study commencement and completion (week 1 and week 4) if they have been conducted. This measurement will not be undertaken by researchers.

Eligibility
Key inclusion criteria
Patients need to be admitted to an Eastern Health subacute ward in order to be eligible for this study. A waiver of consent will be sought from the relevant ethics committees, enabling all patients admitted to receive the intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No oral intake
Receiving end of life care

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)
Allocation will be concealed as patients will not be able to choose the period for which they receive the protected mealtimes. This will be dependent on the ward to which they are admitted. The allocation will be determined by the researcher who will be off-site.

Through the stepped wedge study design, each ward (or cluster) will implement the intervention, adding one ward each week.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order and location of the interventions will be randomized using a computer generated random number sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All clusters (wards) will commence the study simultaneously with usual practice, with the order and location of the interventions randomized. Subacute wards on multiple sites will be utilised to support the stepped wedge study design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations for the study have been conducted to close the energy deficit from actual intake (in the 2013 study of 5900kJ+/-2074kJ) to energy requirements (7801kJ+/-1713kJ). This study has been powered for a stepped wedge design, and 84 observations of 24 hour dietary intake are required across the study sites to have 84% power to detect a significant difference of 0.05 in the primary outcome. An average cluster size of at least seven participants is required. One cluster (ward) will be randomised per step, with three clusters (wards) included in the study.
Outcome data will be recorded on a hard copy template, manually coded and entered into Microsoft Excel, supervised by the principal researcher. Statistical analysis will be performed with Help Stepped wedge (University of Birmingham) with p<0.05 considered statistically significant.
Descriptive statistics (e.g. mean, standard deviation (SD), number (n), frequency (%)) will be used to describe the demographic and baseline characteristics of the sample.

The outcome analysis will primarily consider the change in outcomes between baseline and intervention. Statistical analysis will be supported by a specialist statistician. The mean (SD) change in energy (kJ, kJ/kg body weight) and protein (g, g/kg body weight) intake, Functional Independence Measure score and hand grip strength (kg) will be calculated. Difference in the mean change between groups will be investigated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/10/2015
Actual
13/10/2015
Date of last participant enrolment
Anticipated
2/11/2015
Actual
4/11/2015
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
84
Accrual to date
Final
149
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3218 0
Peter James Centre - Forest Hill
Recruitment hospital [2] 3220 0
Wantirna Health - Wantirna
Recruitment hospital [3] 3221 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 8996 0
3151 - Burwood East
Recruitment postcode(s) [2] 8998 0
3152 - Wantirna
Recruitment postcode(s) [3] 8999 0
3156 - Ferntree Gully

Funding & Sponsors
Funding source category [1] 290320 0
Government body
Name [1] 290320 0
National Health & Medical Research Council
Country [1] 290320 0
Australia
Primary sponsor type
University
Name
Nutrition & Dietetics, Monash University
Address
Level 1,
264 Ferntree Gully Road
Notting Hill Victoria 3168
Country
Australia
Secondary sponsor category [1] 289037 0
Hospital
Name [1] 289037 0
Eastern Health
Address [1] 289037 0
5 Arnold Street
Box Hill Victoria 3128
Country [1] 289037 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292027 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 292027 0
Ethics committee country [1] 292027 0
Australia
Date submitted for ethics approval [1] 292027 0
08/12/2014
Approval date [1] 292027 0
05/01/2015
Ethics approval number [1] 292027 0
Ethics committee name [2] 292028 0
Monash University HREC
Ethics committee address [2] 292028 0
Ethics committee country [2] 292028 0
Australia
Date submitted for ethics approval [2] 292028 0
06/02/2015
Approval date [2] 292028 0
10/02/2015
Ethics approval number [2] 292028 0

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

Contacts
Principal investigator
Name 53118 0
Dr Judi Porter
Address 53118 0
Nutrition & Dietetics
Monash University
Level 1
264 Ferntree Gully Road
Notting Hill
Victoria 3168
Country 53118 0
Australia
Phone 53118 0
+613 9902 4270
Fax 53118 0
Email 53118 0
judi.porter@monash.edu
Contact person for public queries
Name 53119 0
Judi Porter
Address 53119 0
Nutrition & Dietetics
Monash University
Level 1
264 Ferntree Gully Road
Notting Hill
Victoria 3168
Country 53119 0
Australia
Phone 53119 0
+613 9902 4270
Fax 53119 0
Email 53119 0
judi.porter@monash.edu
Contact person for scientific queries
Name 53120 0
Judi Porter
Address 53120 0
Nutrition & Dietetics
Monash University
Level 1
264 Ferntree Gully Road
Notting Hill
Victoria 3168
Country 53120 0
Australia
Phone 53120 0
+613 9902 4270
Fax 53120 0
Email 53120 0
judi.porter@monash.edu

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
SourceTitleYear of PublicationDOI
EmbaseThe efficacy of Protected Mealtimes in hospitalised patients: A stepped wedge cluster randomised controlled trial.2017https://dx.doi.org/10.1186/s12916-017-0780-1
N.B. These documents automatically identified may not have been verified by the study sponsor.