Southampton Mealtime Assistance Study

Malnutrition Clinical Trial

— SMAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647204
• Other study ID #: 09/H0502/93
• Secondary ID: RHM MED0882
• Status: Completed
• Phase: N/A
• First received: July 11, 2012
• Last updated: November 3, 2014
• Start date: November 2009
• Est. completion date: January 2013

Study information

• Verified date: November 2014
• Source: University Hospital Southampton NHS Foundation Trust.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• trained volunteer mealtime assistance
trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust.	University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	end of year 1 and year 2	No
Secondary	patient satisfaction	measured by patient interviews held during each year	end of year 1 and year2	No
Secondary	malnutrition risk	MUST score will be abstracted from medical records	end of year 1 and year2	No
Secondary	length of stay in hospital	taken from hospital records	end of year one and year two	No
Secondary	grip strength	measured using a dynamometer	end of year 1 and year 2	No
Secondary	body composition	triceps and mid upper arm measurement	end of year one and year two and year 3	No
Secondary	mortality	abstracted from hospital records	end of year 1 year 2 and year 3	No