Condition category
Not Applicable
Date applied
31/08/2017
Date assigned
25/09/2017
Last edited
25/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
About 13% of older people living at home are at risk of malnutrition. This may be because they are not getting enough to eat, or because they are not eating enough of the right food. A programme has been developed to help doctors and nurses in general practice to check if older adults who live at home are at risk of malnutrition. They can then offer support to those who need it. This is called ‘Eat well, feel well, stay well’, includes MUST (the Malnutrition Universal Screening Tool), booklets and other materials for older adults, and a support tool for health professionals. The support tool includes guidance about when to see patients and when to use oral nutritional supplements. MUST was developed by experts at BAPEN http://www.bapen.org.uk/. The rest of the intervention was developed by experts who looked at previous literature to find what helps or hinders older adults eating well, and what is likely to work best in general practice. The intervention was improved after feedback from people aged over 65 years, patients and healthcare professionals. This study aims to assess the feasibility and acceptability of the intervention by comparing two versions of the intervention. One is a brief intervention with MUST screening, patient booklets and follow-up; the other is a stepped care intervention. This means that patients will have the brief intervention plus oral nutritional supplements (ONS) for short spells when they are unwell. a group of patients who have the usual care that is provided by their doctors’ surgery are also followed to assess outcomes including change in eating patterns, weight and quality of life. The results of the feasibility study will help us to design a full trial.

Who can participate?
Adults aged 65 and older who have one more major medical or social problems.

What does the study involve?
Practices are randomly allocated to one of three groups. Those in the first group receive the nurse care where they attend a screening appointment to check their health and calculate their MUST score. Participants are offered booklets with lifestyle advice and have a follow up phone call to see how things are going. They are invited to have more appointments and answer a questionnaire after six months. Those in the second group receive the nurse case and are also prescribed oral nutritional supplements. Those in the last group receive the standard care. Participants are followed up at six to nine months.

What are the possible benefits and risks of participating?
For participants who struggle to gain weight, taking part in the study may be beneficial. There are no anticipated risks with participation.

Where is the study run from?
This study is being run by the University of Southampton (UK) and takes place in practices in the UK.

When is the study starting and how long is it expected to run for?
January 2017 to October 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Joanne Kelly
jk1@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Joanne Kelly

ORCID ID

Contact details

University of Southampton
PCPS
Aldermoor Health centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35533

Study information

Scientific title

Screen and TREAt for Malnutrition (STREAM) Programme Workstream 1: Feasibility study

Acronym

STREAM

Study hypothesis

The aim of this study is to assess the feasibility of an intervention in primary care to encourage the use of malnutrition screen and treat (MST) policies for older people living in their own homes.

Ethics approval

North West - Preston Research Ethics Committee, 14/08/2017, ref: 224100

Study design

Randomised; Interventional; Design type: Treatment, Screening, Education or Self-Management, Dietary, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Primary Care, Primary sub-specialty: Ageing; UKCRC code/ Disease: Generic Health Relevance/ No specific disease

Intervention

This is a cluster randomised study. The practices are randomised to one of three study arms:
1. Nurse Care- Participants attend a screening appointment where Grip strength and Timed Up and Go Test (TUGT) are tested. Participants are screened using Malnutrition Universal Screening Tool (MUST). Participants with a MUST score of 1-4 are assessed for underlying problems using a nutritional assessment proforma. They are offered printed booklets addressing their needs, a brief phone follow-up, and brief face-to-face appointments with a practice nurse at intervals, depending on their MUST score. Participants may be referred to a dietitian for further assessment, depending on their MUST score, health and eating status.

2. Nurse Care with stepped approach to prescribing oral nutritional supplements. Participants have their nurse care intervention (as above) and are also be prescribed ONS if needed, initially in short courses during intercurrent illness, and longer courses as necessary.

3. Usual care: Participants continue to have the normal existing medical support provided by their GP surgery.

The total duration of screening and treatment for patients will be 6 months. A nested qualitative study will follow, at six to nine months, with a patients and healthcare professionals who opt to do this.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Health outcomes are measured using SF36 physical outcome at baseline and six months.

Secondary outcome measures

1. Weight/Height/Weight loss is measured at baseline (for intervention groups) and six month (for all groups)
2. Current/recent acute illness/Vitamin/supplement are measured using questionnaires at baseline and six months
3. Appetite is measured using SNAQ appetite questionnaire at baseline and six months
4. Health status is measured using EQ5D5L at baseline and six months
5. Food Frequency is measured using the food frequency questionnaire at baseline and six months
6. Psychological measures (e.g. self-efficacy, outcome expectancy, perceptions of supporter, self-regulation) are measured using questionnaire at baseline and six months
7. Episodes of infection are measured using note review post six month follow up
8. Grip strength - which is a useful marker of malnutrition, and the prognosis of malnutrition is measured using a Jamar Hydraulic Hand Dynamometer at baseline (for intervention groups) and six months (all groups)
9. NHS resource usage (consultations, new conditions identified, or new drugs prescribed, antibiotic use, hospital admissions, care home admissions) and mortality is measured using note reviews post at six month follow up
10. Dietary markers are measured using urine and or blood samples at baseline and six months (optional)

Overall trial start date

01/01/2017

Overall trial end date

01/10/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Be aged ≥ 65 years
2. Have one or more of these major medical or social problem(s) increasing nutritional risk: COPD, cerebrovascular disease, cardiac failure, CKD (stage IIIb/IV/V), chronic liver disease, Crohn’s disease, hospital discharge in previous 2-3 months, Parkinson’s disease, current depression, living alone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 150; UK Sample Size: 150

Participant exclusion criteria

1. Terminal disease
2. Ongoing primary treatment for cancer
3. Diabetes
4. Established dementia
5. Using oral nutritional supplements (ONS)
6. Established nutritional support
7. Unable to consent

Recruitment start date

01/10/2017

Recruitment end date

04/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Salisbury Medical Practice
Fisherton House Fountain Way Wiltshire
Salisbury
SP2 7FD
United Kingdom

Trial participating centre

Cowplain Family Practice
26-30 London Road
Cowplain
PO8 8DL
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

Research Integrity and Governance Manager
Building 37
Room 4079
University Road
Southampton
SO17 1BJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date (feasibility study).

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes