Southampton Mealtime Assistance Study (SMAS)

Introduction of Mealtime Assistance Onto an Acute Medical Ward for Older People

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual mealtime care
patients admitted to the control ward receiving no intervention but usual mealtime help from ward staff
Experimental: mealtime assistance
Additional lunchtime help from trained volunteer mealtime assistants to supplement help from the ward staff
trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean dietary intake of inpatients during a 24 hour period
Time Frame: end of year 1 and year 2

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

end of year 1 and year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: end of year 1 and year2
measured by patient interviews held during each year
end of year 1 and year2
malnutrition risk
Time Frame: end of year 1 and year2
MUST score will be abstracted from medical records
end of year 1 and year2
length of stay in hospital
Time Frame: end of year one and year two
taken from hospital records
end of year one and year two
grip strength
Time Frame: end of year 1 and year 2
measured using a dynamometer
end of year 1 and year 2
body composition
Time Frame: end of year one and year two and year 3
triceps and mid upper arm measurement
end of year one and year two and year 3
mortality
Time Frame: end of year 1 year 2 and year 3
abstracted from hospital records
end of year 1 year 2 and year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helen C Roberts, MB ChB, University of Southampton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 11, 2012

First Submitted That Met QC Criteria

July 20, 2012

First Posted (Estimate)

July 23, 2012

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/H0502/93
  • RHM MED0882 (Other Identifier: UHS R&D ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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