Stow R, Ives N, et al, 2015

26416253

A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents.

Stow R, Ives N, Smith C, Rick C, Rushton A

Trials

2015

16

433

Cluster Randomized Trial

High risk

Resident of one of participating care home facilities with recruitment during September 2013 to December 2013; score of '1' or higher on the Malnutrition Universal Screening Tool (MUST); able to eat and drink; registered with a Solihull GP and subsequently eligible for the provision of healthcare services provided by the Heart of England NHS Foundation Trust (HEFT); cConsent provided at the care home level.

Receiving (or likely to receive in the next 6 months) enteral tube feeding or parenteral nutrition; receiving nutritional support in the form of dietetic advice or prescribed oral nutrition supplements (ONS); have a known eating disorder or illness, which requires a therapeutic diet incompatible with fortification and/or supplementation; on an end of life care pathway; non-native speaker [for participant reported outcome measures (PROMs)]; lacking capacity to consent (PROMs).

In this feasibility trial, the research aim was to explore trial design, staff and resident acceptability of the interventions and outcome measures and to provide data to estimate the parameters required to design a definitive RCT. Primary objectives included: (1) to assess how many care homes accepted the invitation to participate in research, (2) to determine whether the eligibility criteria for care home residents were too open or too restrictive by estimating feasible eligibility and recruitment rate, (3) to assess retention of care homes and residents by estimating 3 and 6-month follow-up rates, (4) to investigate the acceptability of nutritional support interventions to malnourished care home residents in terms of compliance and to care home staff in terms of adherence to the intervention schedule, and 5) to assess the acceptability and feasibility (and factors influencing this) of the outcome measures as methods to measure efficacy of the interventions within a definitive trial.

Residents of the care home were not told of the care home intervention assignment. If a resident questioned the different drink or snack provided, they were told it had been ordered by the dietitian and would be good for them. Staff delivering the interventions were not blinded now was the primary researcher who assigned the intervention and assessed outcome measures.

Borough of Solihull, West Midland, England

Government, Industry

The Heart of England NHS Foundation Trust Nutricia Advanced Medical Nutrition and Nualtra Ltd (provision of supplements)