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Trial registered on ANZCTR


Registration number
ACTRN12613001076763
Ethics application status
Approved
Date submitted
19/09/2013
Date registered
25/09/2013
Date last updated
22/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing Malnutrition in Geriatric Evaluation and Management (GEM) Care: The menu reGEMeration study
Scientific title
The effect of a novel food service model compared to usual care among adult subacute care patients on nutritional, clinical, functional outcomes, patient satisfaction and cost
Secondary ID [1] 283229 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition
290103 0
Condition category
Condition code
Diet and Nutrition 290479 290479 0 0
Other diet and nutrition disorders
Public Health 290571 290571 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a novel food service model comprising of a nourishing hospital menu that includes food and beverage meal items and mid meal snacks with a higher nutrient density than those provided on the standard menu. The nourishing menu will be developed to provide an additional 2mJ per day at minimum, consistent with the energy content of oral nutritional supplements provided frequently to treat or prevent malnutrition part of standard care. Key aspects of the nourishing menu include limiting low energy dense menu options such as broth, tea, coffee, replacing standard soups and desserts with higher energy dense options (e.g. cream, meat or legume based soups; dairy based desserts), providing higher energy dense mid meal snacks and fluids to all patients (e.g. cakes, scones, chocolate biscuits, hot chocolate). Participants in the intervention group will receive the nourishing menu in place of the standard menu for the duration of their inpatient stay. Participants in the intervention group will receive nursing, medical and allied health care, including dietetic services, as usual. Dietetic care related to malnutrition or malnutrition risk may involve standardised provision of oral nutritional supplements, dietary advice, education or other strategies, as appropriate.
Intervention code [1] 287961 0
Treatment: Other
Intervention code [2] 288022 0
Prevention
Comparator / control treatment
The comparator is the standard hospital menu. Participants in the control group will receive nursing, medical and allied health care, including dietetic services, as usual. Dietetic care related to malnutrition or malnutrition risk may involve standardised provision of food, oral nutritional supplements, dietary advice, education or other strategies, as appropriate.
Control group
Active

Outcomes
Primary outcome [1] 290506 0
Change in body weight during inpatient stay where weight is measured to the nearest 0.05kg using a single set of calibrated seated scales with the participant dressed in light clothing. Self reported weight will be collected where weight cannot be measured.
Timepoint [1] 290506 0
Weight will be measured on admission at baseline and weekly thereafter until the participant is discharged. Change in weight will be calculated as the difference between weight at baseline and day 14 and at baseline and the last measurement prior to discharge.
Secondary outcome [1] 304662 0
Mean daily energy and protein intake will be measured with a one day record of plate waste at meals (breakfast, lunch and dinner) and mid meals (morning tea, afternoon tea, supper). Plate waste will be determined by observation using a six point template (none, 1 mouthful, 1/4, 1/2, 3/4, all). Patients will be asked to self report intake if meals are not finished within reasonable time or if foods other than hospital meals are consumed (e.g. food from visitors).
Energy and protein intake of the portion of the meal consumed will be determined based on known nutritional information for food and beverages provided as part of the standard or nourishing hospital menu or calculated from NUTTAB 2010 database in Foodworks Version: 7.0 Copyright 2012 Xyris Software (Australia) using assumed serve sizes.
Timepoint [1] 304662 0
A one day food record will be completed on admission at baseline, at day 14 of admission and fortnightly thereafter until the participant is discharged.
Secondary outcome [2] 304671 0
Change in mean hand grip strength (HGS) will be measured with a Jamar Plus + Hand Dynamometer with the participant sitting upright in a chair or bed with the elbow flexed at 90degrees, the forearm neutrally positioned and the wrists dorsi-flexed at 30degrees as recommended by the American Society of Hand Therapists (ASHT) protocol. Participants will be given a demonstration and provided with standard instructions on how to complete the measurement. Three measurements will be taken on each hand and the mean value for each hand will be calculated.
Timepoint [2] 304671 0
HGS will be measured on admission at baseline, at day 14, day 21, day 28 and fortnightly thereafter. Change in HGS will be calculated as the difference between the highest mean result (left or right hand) at baseline and day 14 and at baseline and the last measurement prior to discharge.
Secondary outcome [3] 304672 0
Change in Functional independence measure (FIM) total score. This is a validated tool that assesses patients’ level of dependence /independence for 18 basic activities of daily living (ADLs) relating to motor and cognitive function. A score of 18–126 is calculated with higher scores representing more independence. FIM data will be completed by nursing staff as this is part of usual care
Timepoint [3] 304672 0
The FIM will be completed on admission at baseline and at discharge. Change in FIM total score will be calculated as the difference between the FIM score at discharge and admission.
Secondary outcome [4] 304673 0
Patient satisfaction will be determined using The acute care hospital foodservice patient satisfaction questionnaire. This is a validated tool that includes 19 questions relating to food quality, meal service quality, staff/service issues and the physical environment, assessed with a 5 point Likert scale.
Timepoint [4] 304673 0
Patient satisfaction will be measured on day 14 of admission.
Secondary outcome [5] 304675 0
Length of inpatient stay
Timepoint [5] 304675 0
Length of stay will be calculated as the number of days between admission and discharge from subacute care.
Secondary outcome [6] 304676 0
Inpatient mortality.
Timepoint [6] 304676 0
This outcome will be recorded if participant mortality occurs between admission and discharge.
Secondary outcome [7] 304677 0
Destination upon discharge from subacute care (e.g. acute hospital/ usual place of residence/ place of residence providing a higher level of care than pre-morbid place of residence)
Timepoint [7] 304677 0
This outcome will be determined at the time of discharge from subacute care.
Secondary outcome [8] 304678 0
The incremental cost of the intervention menu compared to the standard menu. This will be calculated as the sum of labour, food and drink consumables and capital costs. Labour costs will be determined as a product of estimated time taken for food service staff to complete tasks associated with the intervention and the hourly rate, plus oncosts, according to the relevant award. Food and drink costs will be determined for the default menu for the standard and intervention menus. Capital costs will take into account new equipment purchased to support the intervention menu.
Timepoint [8] 304678 0
Cost will be calculated retrospectively following the completion of the study.

Eligibility
Key inclusion criteria
Adult patients admitted to the GEM ward at a single hospital in metropolitan Melbourne will be eligible for inclusion. Inclusion will not be limited by provision of consent as ethical approval was granted to conduct this research under a waiver of consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients not receiving oral nutrition (e.g. solely enteral or parenteral nutrition)
2. Patients receiving only palliative care
3. Patients with significant food allergies or intolerances which cannot be catered for with the nourishing menu
4. Patients receiving texture modified food or fluid which cannot be catered for with the nourishing menu
5. Patients with other dietary restrictions which cannot be catered for with the nourishing menu
6. Patients with weight loss as a documented rehabilitation goal

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)
Potential participants will be assigned to the intervention or the control group based on their allocation to a hospital bed on admission (see below). Bed allocation will be completed as per usual protocol by the bed manager who will be blinded to the randomisation procedure. Participants will then be enrolled in the study if eligibility criteria are met.
Allocation is not concealed as group assignment occurs prior to participant enrollment due to the nature of the allocation procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used with each block being half of the ward. Half of the hospital rooms (one or four beds per room) on the ward will be assigned as intervention or control at the commencement of the study and will be alternated halfway through recruitment to account for any potential bias in patients' room allocation. Participant allocation to each room will occur as usual and will be psuedorandomised as described above.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The purpose of the study is to evaluate the intervention as both a treatment and prevention for malnutrition.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All statistical analysis will be completed using IBM SPSS. A p value of <0.05 will be considered statistically significant.

Descriptive statistics will be used to describe the demographic and baseline characteristics of the sample, with differences between groups investigated with independent samples T test, Mann Whitney U test or chi2 test, as appropriate.

The mean (SD) change in weight, energy and protein intake, FIM and HGS will be calculated as the difference between the discharge and baseline measurements. Difference in the mean change between groups will be investigated with independent samples T test. Analysis of covariance (ANCOVA) will be used to compare the mean change in weight, energy intake, protein intake and HGS between the intervention and the control group while controlling for other variables which may be potential confounders (e.g age, FIM).

Responses for the patient satisfaction questionnaire will be collapsed from a 5 point likert scale to a 3 point scale (agree/neutral/disagree) for each question and number and proportion of responses will be reported and compared across groups using the chi2 test. Overall and domain scores will be also be calculated from the patient satisfaction questionnaire by assigning values 1-5 to the 5 point likert scale. Differences between groups will be assessed using the independent samples T test or Mann Whitney U test, as appropriate.

Descriptive statistics will be reported for other outcomes (e.g. LOS, inpatient mortality, discharge destination) with differences between groups investigated with independent samples T test, Mann Whitney U test or chi2 test, as appropriate.

To examine if the effect of the intervention is associated with nutrition status on admission, data will be stratified to separate well nourished and malnourished patients.

Sample size calculation was based on a time delineated predetermined phase of four months of participant recruitment. It was determined that a total of 166 participants could be recruited based on an average length of stay of 19 days determined from ward admissions data, the assumption that 32 beds remain open on the ward and that a maximum of 6 out of every 32 admitted patients will be ineligible to participate. This will result in a maximum sample size of 83 participants in each group. Data generated during the 4 month study period will allow calculation of the sample size required to fully power the RCT to detect a change in the primary outcome. The study period may be extended to recruit the required sample size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1535 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 7372 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 287997 0
Hospital
Name [1] 287997 0
Dietetics Department, Maroondah hospital
Address [1] 287997 0
Davey Drive
Ringwood East, VIC
3135
Country [1] 287997 0
Australia
Primary sponsor type
Individual
Name
Dr Judi Porter
Address
Department of Nutrition and Dietetics
Monash University
Level 1
264 Ferntree Gully road
Notting Hill, VIC
3168
Country
Australia
Secondary sponsor category [1] 286716 0
Individual
Name [1] 286716 0
Kate Huggins
Address [1] 286716 0
Department of Nutrition and Dietetics
Monash University
Level 1
264 Ferntree Gully road
Notting Hill, VIC
3168
Country [1] 286716 0
Australia
Secondary sponsor category [2] 286718 0
Individual
Name [2] 286718 0
Helen Truby
Address [2] 286718 0
Department of Nutrition and Dietetics
Monash University
Level 1
264 Ferntree Gully road
Notting Hill, VIC
3168
Country [2] 286718 0
Australia
Other collaborator category [1] 277626 0
Individual
Name [1] 277626 0
Jorja Collins
Address [1] 277626 0
Department of Nutrition and Dietetics
Monash University
Level 1
264 Ferntree Gully road
Notting Hill, VIC
3168
Country [1] 277626 0
Australia
Other collaborator category [2] 277627 0
Hospital
Name [2] 277627 0
Maroondah Hospital
Address [2] 277627 0
Davey Drive
Ringwood East, VIC
3135
Country [2] 277627 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289922 0
Eastern Health Office of Research and Ethics
Ethics committee address [1] 289922 0
Level 2, 5 Arnold Street, Box Hill, 3128, Victoria
Ethics committee country [1] 289922 0
Australia
Date submitted for ethics approval [1] 289922 0
28/08/2013
Approval date [1] 289922 0
16/09/2013
Ethics approval number [1] 289922 0
LR23/1314

Summary
Brief summary
Malnutrition is a condition with negative implications affecting a substantial number of patients in healthcare facilities across Australia. It develops as a result of inadequate food intake, occurring due to factors associated with disease, illness and ageing and is often exacerbated by aspects of the hospital environment such as food provision.

Preliminary data collected from subacute care inpatients (rehabilitation and Geriatric Evaluation and Management (GEM)) underpins this intervention trial. This research found that the 30% of patients were malnourished on admission and that overall, patients lost weight and muscle mass, demonstrating a decline in their nutritional status during inpatient stay. Additionally, less than 15% of patients consumed sufficient food or drink to provide 100% of their energy requirements and only half of all patients met 75% of their requirements. Well-nourished and malnourished patients alike experienced inadequate intake and nutritional decline. These data strongly suggest the need for more effective interventions to lower the risk of progression of malnutrition in healthcare facilities.

Modifying or enhancing the nutritional value of food or drink or increasing the provision of items at meals and mid meals in hospital may be an approach that is more palatable and satisfying for patients and economically beneficial, compared to the provision of oral nutrition supplement drinks which are used widely in practice. There is some evidence from a handful of studies conducted across a range of healthcare settings that food based approaches result in greater dietary intake and patient centred outcomes, but there is a lack of evidence on clinical and functional benefits and cost. Additionally, previously high quality studies are lacking.

The aim of this research is to implement a novel food service model to determine the effect of a nourishing menu compared to a usual menu on nutritional and clinical outcomes, patient satisfaction and cost among malnourished and well-nourished adult sub-acute care patients. This research will test the null hypotheses that there is no difference in weight change and cost of delivery between the intervention and the control. It is anticipated that the findings of this research, including data on cost of food service interventions, will have clinical relevance for the operation of the food service systems and dietetic practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43006 0
Dr Judi Porter
Address 43006 0
Department of Nutrition and Dietetics
Monash University
Level 1
264 Ferntree Gully road
Notting Hill, VIC
3168
Country 43006 0
Australia
Phone 43006 0
+61 03 9902 4264
Fax 43006 0
Email 43006 0
judi.porter@monash.edu
Contact person for public queries
Name 43007 0
Miss Jorja Collins
Address 43007 0
Department of Nutrition and Dietetics
Monash University
Level 1
264 Ferntree Gully road
Notting Hill, VIC
3168
Country 43007 0
Australia
Phone 43007 0
+61 03 9902 4199
Fax 43007 0
Email 43007 0
jorja.collins@monash.edu
Contact person for scientific queries
Name 43008 0
Miss Jorja Collins
Address 43008 0
Department of Nutrition and Dietetics
Monash University
Level 1
264 Ferntree Gully road
Notting Hill, VIC
3168
Country 43008 0
Australia
Phone 43008 0
+61 03 9902 4199
Fax 43008 0
Email 43008 0
jorja.collins@monash.edu

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary