Southampton Mealtime Assistance Study (SMAS)
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
trained volunteer mealtime assistance
Sponsored by
About this trial
This is an interventional health services research trial for Malnutrition focused on measuring Nutrition, older, hospital, volunteer
Eligibility Criteria
Inclusion Criteria:
Patients will be recruited in a consecutive prospective manner.
- emergency admissions to acute medical wards and
- ability to gain consent from patient or relatives
Exclusion Criteria:
- Patient acutely unwell or palliative care
- Patient lacking capacity to consent and no assent given by relatives
- Patients who are tube fed or nil-by-mouth
Sites / Locations
- University Hospital Southampton
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
usual mealtime care
mealtime assistance
Arm Description
patients admitted to the control ward receiving no intervention but usual mealtime help from ward staff
Additional lunchtime help from trained volunteer mealtime assistants to supplement help from the ward staff
Outcomes
Primary Outcome Measures
mean dietary intake of inpatients during a 24 hour period
The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward.
Dietary intake measured as energy and protein
Secondary Outcome Measures
patient satisfaction
measured by patient interviews held during each year
malnutrition risk
MUST score will be abstracted from medical records
length of stay in hospital
taken from hospital records
grip strength
measured using a dynamometer
body composition
triceps and mid upper arm measurement
mortality
abstracted from hospital records
Full Information
NCT ID
NCT01647204
First Posted
July 11, 2012
Last Updated
November 3, 2014
Sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
University of Southampton
1. Study Identification
Unique Protocol Identification Number
NCT01647204
Brief Title
Southampton Mealtime Assistance Study
Acronym
SMAS
Official Title
Introduction of Mealtime Assistance Onto an Acute Medical Ward for Older People
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
University of Southampton
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward. The sustainability of providing helpers to increase dietary intake over a year will be assessed and linked to actual dietary intake. The secondary objectives are to assess the association between dietary intake resulting from mealtime assistance and patient satisfaction, malnutrition risk, body composition, grip strength, length of hospital stay and hospital mortality.
Detailed Description
Poor nutritional status in older people acutely admitted to hospital is common with the risk of malnutrition estimated to be greater than 40%. Malnutrition is associated with major adverse clinical outcomes such as increased mortality, morbidity and length of stay at enormous cost to individuals and the health service. There is growing recognition that malnutrition is often unrecognised and untreated, and that many patients are discharged from hospital in a more malnourished state than when they were admitted. It is not surprising that complaints about nutrition and food services are amongst the commonest complaints in NHS hospitals.
The standard of mealtime care in UK hospitals has been an issue of concern for a number of years. A report last year from the Healthcare Commission found that one in five patients who wanted help eating did not get it. A secondary analysis of data provided by the Health Care Commission suggests that in some hospitals two out of five patients who wanted help with eating did not get it. Consistent with this, the recent Hungry to be Heard report found that nine out of ten nurses indicated they did not always have time to help ensure patients ate properly. They also suggested that some patients were not given appropriate assistance to eat. This problem is not unique to the UK and has been reported in other countries such as Australia and the USA.
The aim of the present study is to investigate if the use of volunteers employed specifically to focus on mealtime assistance in a Care of the Elderly Ward can increase food and nutrient intake, impact on body composition and improve clinical outcomes. The findings will inform service development in the nutritional care of older people across the Trust and wider.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Nutrition, older, hospital, volunteer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual mealtime care
Arm Type
No Intervention
Arm Description
patients admitted to the control ward receiving no intervention but usual mealtime help from ward staff
Arm Title
mealtime assistance
Arm Type
Experimental
Arm Description
Additional lunchtime help from trained volunteer mealtime assistants to supplement help from the ward staff
Intervention Type
Other
Intervention Name(s)
trained volunteer mealtime assistance
Intervention Description
trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required
Primary Outcome Measure Information:
Title
mean dietary intake of inpatients during a 24 hour period
Description
The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward.
Dietary intake measured as energy and protein
Time Frame
end of year 1 and year 2
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
measured by patient interviews held during each year
Time Frame
end of year 1 and year2
Title
malnutrition risk
Description
MUST score will be abstracted from medical records
Time Frame
end of year 1 and year2
Title
length of stay in hospital
Description
taken from hospital records
Time Frame
end of year one and year two
Title
grip strength
Description
measured using a dynamometer
Time Frame
end of year 1 and year 2
Title
body composition
Description
triceps and mid upper arm measurement
Time Frame
end of year one and year two and year 3
Title
mortality
Description
abstracted from hospital records
Time Frame
end of year 1 year 2 and year 3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients will be recruited in a consecutive prospective manner.
emergency admissions to acute medical wards and
ability to gain consent from patient or relatives
Exclusion Criteria:
Patient acutely unwell or palliative care
Patient lacking capacity to consent and no assent given by relatives
Patients who are tube fed or nil-by-mouth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen C Roberts, MB ChB
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Southampton
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28244573
Citation
Roberts HC, Pilgrim AL, Jameson KA, Cooper C, Sayer AA, Robinson S. The Impact of Trained Volunteer Mealtime Assistants on the Dietary Intake of Older Female In-Patients: The Southampton Mealtime Assistance Study. J Nutr Health Aging. 2017;21(3):320-328. doi: 10.1007/s12603-016-0791-1.
Results Reference
derived
PubMed Identifier
23294981
Citation
Roberts HC, Pilgrim AL, Elia M, Jackson AA, Cooper C, Sayer AA, Robinson SM. Southampton Mealtime Assistance Study: design and methods. BMC Geriatr. 2013 Jan 7;13:5. doi: 10.1186/1471-2318-13-5.
Results Reference
derived
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Southampton Mealtime Assistance Study
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