Around 366 adults with swallowing difficulties will be randomly assigned to either stop using thickened fluids or continue them, to see which approach improves quality of life. Thickened fluids are a standard treatment for oropharyngeal dysphagia, a condition where food or drink can enter the airway and cause pneumonia. Yet the evidence that thickening actually prevents this is weak and inconclusive. Many patients dislike the taste and texture, and the extra cost and preparation time can be burdensome. This trial directly tests whether stopping thickened fluids—under a structured discontinuation protocol—harms or helps patients. If discontinuing thickened fluids proves safe and improves quality of life, the impact could be immediate and practical. Speech and language therapists would gain clear guidance on when and how to stop a treatment that may be unnecessary. Patients could enjoy normal drinks again without guilt or fear, and the NHS could save the cost of thickener prescriptions for thousands of people. The trial also tracks pneumonia rates, hydration, and nutrition, ensuring safety is not compromised. This is a pragmatic clinical trial, not fundamental science. Its success would change a widespread clinical practice based on evidence rather than habit.
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RESEARCH TITLE: The clinical and cost effectiveness of discontinuing thickened fluids compared to continuing thickened fluids in adults with slowly progressing oropharyngeal dysphagia (INGEST: dIscontinuing or continuiNG thickEned fluidS Trial) BACKGROUND: Dysphagia is the medical term for difficulty swallowing. Oropharyngeal dysphagia affects the mouth and throat, occurring when a person has difficulty moving the food or fluid to the back of the mouth and starting the swallowing process. Thickened fluids are a commonly used intervention for people with dysphagia as their properties mean they transit the swallow mechanism more slowly compared to thin fluids, allowing more time for the airway protection mechanisms to avoid fluids entering the airway and potentially reaching the lungs. The evidence supporting the use of thickened fluids is limited and inconclusive. AIM: The aim of this study is to determine the clinical and cost effectiveness of discontinuing thickened fluids compared to continuing thickened fluids in adults with slowly progressing oropharyngeal dysphagia. OBJECTIVES: Explore whether discontinuing thickened fluids improves quality of life; Undertake a 7-month internal pilot to confirm the feasibility of recruitment; Estimate the difference between groups for a range of secondary outcomes; Conduct a cost-utility analysis; Undertake a nested qualitative study to inform trial processes, acceptability and fidelity of the intervention and optimisation of discontinuation. METHODS: Multicentre, randomised controlled trial with internal pilot, economic evaluation and nested qualitative study. The study will include 366 adults with slowly progressing dysphagia caused by any health condition, receiving thickened fluids for at least a month and expected to continue, receiving any consistency of fluid, under the care of a SLT and who are living in the community. The control group will continue to use thickener as prescribed. The intervention group will follow a discontinuation protocol to stop using thickener. Data will be collected at baseline, 6 weeks and 3, 6 and 12 months. The primary outcome is the Swallowing Quality of Life (SWAL-QOL) questionnaire at 6 weeks. Secondary outcomes include SWAL-QOL total and domain scores, any pneumonia incidence, hydration, nutritional status, body weight, mental health, health-related quality of life, resource use, mealtime performance and adherence, patient/carer acceptability and fidelity to discontinuation protocol, carer burden, adverse events, side effects and mortality. TIMELINES FOR DELIVERY: Duration 48 months: months 1-9 study setup, 10-16 internal pilot, 17-30 main trial recruitment, 12-42 follow-up, 43-48 data analysis, write up and dissemination. IMPACT AND DISSEMINATION: This research has the potential to change the use of thickened fluids for people with dysphagia, positively impacting their quality of life and providing clear guidance for SLTs on how and when to discontinue the use of thickened fluids. Throughout the project we will engage with the full range of stakeholders for whom the study will be of relevance and interest, connecting through local, regional and national organisations. We will use a range of methods to reach a diverse audience, including accessible newsletters, infographics, animations and social media. We will publish open access articles in academic and practice journals and present at conferences.
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