REFRESH study: nutRition intervEntions For malnouRished oldEr adultS in care Homes - A parallel, superiority, three-arm cluster randomised controlled trial.

Research question

In older adults with or at risk of malnutrition living in care homes, what is the clinical- and cost-effectiveness of oral nutritional supplements (ONS) and fortified food (FF) for improving quality of life and nutritional outcomes, compared to routine practice (control arm)? Background

This commissioned call sought to establish an evidence base for the effectiveness and cost-effectiveness of ONS. We chose to set this in care homes, which house approximately 361,000 people in the UK. Malnutrition is common (26-42%) and consequently ONS are used frequently.

However, many ONS are wasted, and their effectiveness in care homes is not yet established. Care homes are an under-researched setting: only one UK trial has attempted to evaluate cost-effectiveness of ONS in care homes. Food fortification is the recommended approach to treating malnutrition in this setting and thus, we will also test a fortified food menu and snacks.

Objectives 1.Evaluate the clinical and cost effectiveness of prescribed ONS and FF compared with routine practice

2.Undertake a mixed methods process evaluation to understand trial processes, mechanisms and context to inform longer term follow-up of the trial participants

3.Conduct a Study within a Project examining the barriers to recruitment and strategies to support retention of older residents from different cultural backgrounds and to refine the intervention for ethnic minority groups Methods

A three-arm cluster randomised controlled trial to compare the effectiveness of ONS and FF with routine care to improve quality of life in older adults with malnutrition living in care homes (90 care home clusters, 1530 participants altogether). Health economic evaluation will be embedded and mixed methods process evaluation following MRC complex interventions guidelines.

The first of three recruitment phases (30 homes) will act as an internal pilot. Residents will be followed up at 6 months for all outcomes and 12 months for quality of life and health economic data. Timelines for delivery

Recruitment will begin Oct 25, internal pilot will be completed by Jan 26, recruitment will be completed by May 27, follow up will be complete by May 28, results will be presented Aug 28 and final report submitted by Dec 28, with a plan for on-going implementation. Anticipated impact and dissemination

The main impact will be evidence to support the most effective method to treat and manage malnutrition in care homes. Improving the management of malnutrition will help reduce deterioration in mental and physical health and wellbeing for older people, leading to the potential for improved quality of life, pleasure in eating, maintain independence for as long as possible, reduce carer burden and associated costs.

The health & care system will also benefit since this population group are high users of these services. Effective provision of nutritional care and improved management of malnutrition will reduce resource use (e.g. reduced hospitalisations, infections that require NHS resources). Thus, as a successful definitive trial, we would expect the new knowledge to be adopted across integrated NHS & Social Care systems and impact evidence-based practice guidelines (NICE) and national (Malnutrition Care Pathway) and regional care pathways for managing malnutrition.

This would be guided through the involvement of public advisors, policy makers and commissioners on our Trial Steering Group, including Care Quality Commission.