Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000833662
Ethics application status
Approved
Date submitted
24/07/2014
Date registered
6/08/2014
Date last updated
1/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can provision of ambulatory nutrition services to patients discharged from acute care improve health outcomes at an acceptable cost?
Scientific title
Effect of Dietary modification versus no dietary modification on length of hospital stay, hospital re-admission rate, mortality, quality of life and associated costs in hospitalised malnourished patients.
Secondary ID [1] 284725 0
NIL
Universal Trial Number (UTN)
U1111-1157-9341
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition in Hospitalized patients 292074 0
Condition category
Condition code
Diet and Nutrition 292413 292413 0 0
Other diet and nutrition disorders
Public Health 292928 292928 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients admitted in General Medicine ward will be screened for malnutrition by a member of research team, using Malnutrition Universal Screening tool(MUST) and those found to be malnourished will be stratified according to cognitive status into two groups - cognitively normal and cognitively impaired and will be referred to a dietitian who will perform a detailed nutritional assessment using PG-SGA(Patient Generated Subjective Global Assessment) tool and patients will be randomized to intervention and control group. Patients in the intervention group will receive nutritional intervention which may include dietary modification or nutritional supplements and will be followed every month by a telephone call to check compliance for two months and at the end of three months will be seen in dietary clinic for repeat nutritional assessment and cost benefit analysis will be calculated and patients in the control group will follow usual care which does not include prolonged ambulatory dietary intervention.
Nutrition Intervention:
The dietitian will set realistic goals negotiated with the patient in an effort to prevent decline in nutritional status. The PG-SGA and calculation of estimated requirements will provide guidance on areas of potential nutritional inadequacy and the diet intervention will be tailored to address these. The duration of nutritional intervention will be single one hour session at the baseline and thirty minutes reviews.
Intervention code [1] 289507 0
Treatment: Other
Intervention code [2] 289508 0
Lifestyle
Comparator / control treatment
The control group includes malnourished admitted patients who will receive the standard care of treatment being followed in the hospital which does not routinely include dietary intervention over extended period of time after hospital discharge.
Control group
Active

Outcomes
Primary outcome [1] 292275 0
Improvement in Patient Generated Subjective Global Assessment (PG-SGA) score.
Timepoint [1] 292275 0
Baseline and at three months
Primary outcome [2] 292276 0
European5 Quality of Life(EQ5D) Score
Timepoint [2] 292276 0
At baseline and then at three months
Primary outcome [3] 292277 0
Hospital Re-admission rate
This will be determined by data linkage to patient medical records.
Timepoint [3] 292277 0
At three months as compared to control group
Secondary outcome [1] 308612 0
Cost-benefit analysis
The evaluation will be based on a primary outcome of cost per unit reduction in the PG-SGA( Patient generated Subjective Global Assessment) during the intervention period. That is, how much savings can be attributed to one unit of improvement in nutritional status. Utility-based outcomes will be incorporated into the analysis allowing a secondary outcome to be cost per QALY gained (based on the EQ5D level values). This will be determined using European Quality of Life Questionnaire(EQ5D) and Quality adjusted Life years(QALY) will be calculated.
Timepoint [1] 308612 0
At the end of three months as compared to control group.
Secondary outcome [2] 308613 0
Mortality
Timepoint [2] 308613 0
At three months as compared to control group.

Eligibility
Key inclusion criteria
Patients admitted to general medicine ward aged sixty years or above, Ability to provide written consent or consent obtained from legal guardian if cognitively impaired, Identified as malnourished according to a standard malnutrition screening instrument-Malnutrition Universal Screening Tool (MUST).
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Resides outside metropolitan Adelaide, Inability to obtain consent, non-english speaking, Aborigines, palliative patients.

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)
All patients admitted under general medicine will be screened by research associate using Malnutrition Universal Screening Tool(MUST) and Allocation concealment will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be created by an independent statistician using ralloc.ado version 3.6.1 in Stata version 11.1. Treatment allocations will be randomly permuted and balanced within blocks and stratified according to cognitive status (history of dementia/delirium vs no cognitive impairment). Numbered opaque envelopes will conceal allocation until baseline assessments have been completed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Primary analysis for this study will be undertaken using intention to treat principles. Stratified randomisation by cognitive status (history of dementia/delirium vs no cognitive impairment) will be utilised. Central tendency and distribution will be determined and data presented as appropriate. Conditional upon fulfilling required statistical assumptions and on measurement level of the variables Independent samples t-tests, Mann-Whitney U tests or Chi-square test of association will be used to compare groups at baseline. Any identified variables that are different despite applying randomisation will be investigated and if required entered into subsequent models as confounders. To determine differences between the groups, repeated measures ANOVA with one between and one within factor and their interaction will be considered. If amount of missing data due to death or withdrawal will make a list wise approach to dealing with absent responses inappropriate, linear mixed models (LMM) will be utilised instead. Finally, if severe violation of the LMM statistical assumptions regarding PG-SGA and EQ-5D distributions occurs then generalized linear mixed models will be used. Survival analysis will be undertaken to compare groups for length of stay, time to first hospital readmission or presentation to emergency department and time to death. Statistical analyses will be undertaken using relevant software including SPSS and STATA.

For the primary outcome of nutritional status as measured by the scored PG-SGA, it has been recommended that a shift of three points is clinically meaningful. Literature using scored PG-SGA in similar populations indicates an average SD of approximately 4.3. This estimate was used in the estimate of sample size resulting in a standardized effect size of f=0.35. Repeated measures between factor ANOVA sample size estimation procedure available in software G*Power3 was used to calculate the sample size for this project. Assuming an effect size f=0.35, alpha=0.002, power 80%, with two levels for between factor and two repeated measurements (correlated at 0.5 level) the estimated required sample size is 86 (43 per group). To allow for deaths and withdrawals (15% each), a total of 112 participants will be recruited (56 per group). A sample size of 86 will be sufficient to detect the difference of 0.18 units in EQ-5D quality of life scale as based on a theoretical SD value for EQ-5D equal to 0.25.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2014
Actual
28/11/2014
Date of last participant enrolment
Anticipated
31/12/2016
Actual
24/06/2016
Date of last data collection
Anticipated
Actual
4/10/2016
Sample size
Target
112
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2539 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 8221 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 289342 0
Self funded/Unfunded
Name [1] 289342 0
Country [1] 289342 0
Primary sponsor type
Individual
Name
Dr Yogesh Sharma
Address
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 288027 0
Individual
Name [1] 288027 0
A/Prof Michelle Miller
Address [1] 288027 0
Department of Nutrition and Dietetics
Flinders University
Flinders Drive
Bedford Park SA 5042
Country [1] 288027 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291129 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 291129 0
Ethics committee country [1] 291129 0
Australia
Date submitted for ethics approval [1] 291129 0
04/06/2014
Approval date [1] 291129 0
21/07/2014
Ethics approval number [1] 291129 0
273.14 - HREC/14/SAC/282

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

Contacts
Principal investigator
Name 48910 0
Dr Yogesh Sharma
Address 48910 0
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 48910 0
Australia
Phone 48910 0
+61882046694
Fax 48910 0
+61882046255
Email 48910 0
Yogesh.Sharma@health.sa.gov.au
Contact person for public queries
Name 48911 0
Yogesh Sharma
Address 48911 0
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 48911 0
Australia
Phone 48911 0
+61882046694
Fax 48911 0
+61882046255
Email 48911 0
Yogesh.Sharma@health.sa.gov.au
Contact person for scientific queries
Name 48912 0
Yogesh Sharma
Address 48912 0
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country 48912 0
Australia
Phone 48912 0
+61882046694
Fax 48912 0
+61882046255
Email 48912 0
Yogesh.Sharma@health.sa.gov.au

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
EmbaseMalnutrition and its association with readmission and death within 7 days and 8-180 days postdischarge in older patients: A prospective observational study.2017https://dx.doi.org/10.1136/bmjopen-2017-018443
EmbaseEconomic evaluation of an extended nutritional intervention in older Australian hospitalized patients: a randomized controlled trial.2018https://dx.doi.org/10.1186/s12877-018-0736-0
N.B. These documents automatically identified may not have been verified by the study sponsor.