Southampton Mealtime Assistance Study (SMAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Hospital Southampton NHS Foundation Trust..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Southampton
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier:
NCT01647204
First received: July 11, 2012
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Malnutrition
Other: trained volunteer mealtime assistance

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Introduction of Mealtime Assistance Onto an Acute Medical Ward for Older People

Resource links provided by NLM:


Further study details as provided by University Hospital Southampton NHS Foundation Trust.:

Primary Outcome Measures:
  • mean dietary intake of inpatients during a 24 hour period [ Time Frame: end of year 1 and year 2 ] [ Designated as safety issue: No ]

    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 [ Time Frame: end of year 1 and year2 ] [ Designated as safety issue: No ]
    measured by patient interviews held during each year

  • malnutrition risk [ Time Frame: end of year 1 and year2 ] [ Designated as safety issue: No ]
    MUST score will be abstracted from medical records

  • length of stay in hospital [ Time Frame: end of year one and year two ] [ Designated as safety issue: No ]
    taken from hospital records

  • grip strength [ Time Frame: end of year 1 and year 2 ] [ Designated as safety issue: No ]
    measured using a dynamometer

  • body composition [ Time Frame: end of year one and year two and year 3 ] [ Designated as safety issue: No ]
    triceps and mid upper arm measurement

  • mortality [ Time Frame: end of year 1 year 2 and year 3 ] [ Designated as safety issue: No ]
    abstracted from hospital records


Estimated Enrollment: 342
Study Start Date: November 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: trained volunteer mealtime assistance
trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647204

Contacts
Contact: Helen C Roberts, MbChB 0044 2380 79 ext 4354 hcr@soton.ac.uk

Locations
United Kingdom
University Hospital Southampton Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Helen C Roberts, MB ChB    0044 238079 ext 4354    hcr@soton.ac.uk   
Principal Investigator: Helen C Roberts, MB ChB         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust.
University of Southampton
Investigators
Principal Investigator: Helen C Roberts, MB ChB University of Southampton
  More Information

No publications provided by University Hospital Southampton NHS Foundation Trust.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier: NCT01647204     History of Changes
Other Study ID Numbers: 09/H0502/93, RHM MED0882
Study First Received: July 11, 2012
Last Updated: July 20, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospital Southampton NHS Foundation Trust.:
Nutrition
older
hospital
volunteer

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 16, 2014