A simple home saliva test could replace a costly, time-consuming hospital procedure that thousands of patients with suspected adrenal insufficiency currently endure. The current diagnostic pathway for adrenal insufficiency—a condition where the body cannot produce enough cortisol—relies on an early morning blood test that is often inconclusive. Sixty percent of patients then require a Short Synacthen Test, which demands a daycare hospital admission, trained nursing staff, and can have waiting lists of up to six months. Researchers in Sheffield have already shown that a waking saliva cortisone (WSC) test works accurately at home, cutting costs and reducing treatment burden. Now they want to roll it out across the NHS. Over 42 months, the team will implement WSC in four geographically diverse NHS Trusts, measuring how many usable test results it produces compared to current tests. They will also assess costs, identify barriers to uptake, and ensure the test works for patients from different ethnic and socioeconomic backgrounds. If successful, widespread adoption of WSC could save the NHS an estimated £24 million per year while shifting care from hospital to home.
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Research Question Can the current Adrenal Insufficiency diagnostic pathway for adults & children be improved by implementing a new home-based saliva test across different NHS Trusts? Background Cortisol levels peak soon after waking. The current diagnostic pathway for cortisol deficiency (Adrenal Insufficiency, AI) aims to capture the peak by an early morning cortisol (EMC) blood test. EMC results are often equivocal so 60% need a Short Synacthen Test (SST). These tests have a high treatment burden with patients having to travel to hospital early in the morning for blood tests/injections. The SST is expensive, requiring a daycare admission and highly trained nursing staff. SST waiting lists are up to six months. As an alternative we have shown that home waking saliva cortisone (WSC) is an accurate replacement test. WSC reduces costs and patients prefer it to the SST due to reduced treatment burden. We have implemented WSC in clinical care at the children’s and adult hospitals in Sheffield where it is established as the first line diagnostic test for AI. Now we want to learn how to adopt WSC across the NHS. NICE has recommended studies to encourage WSC implementation. Aims & objectives We would like to develop an Implementation Strategy for successful NHS rollout of WSC. We want to evaluate whether clinicians in endocrine departments in four Trusts decide to use WSC (replacement test) or EMC/SST (current tests) as first line for AI. We aim to develop an Implementation Strategy, understand facilitators & barriers to implementation via a process evaluation and compare the costs of the old & new testing pathways in an economic evaluation. We will identify adaptations to improve inclusiveness using 4 different communities so WSC is accessible to all patients. Methods & timelines Methods have been discussed, refined and supported by our PPIE group. We will carry out a three stage sequential mixed methods study in 4 geographically disparate Trusts, all serving adults & children. In stage 1 (months 1-9), work package 1 will focus on developing an Implementation Strategy, including support for clinical staff, business managers, changes in laboratory systems and procurement of saliva collection kit components. Work package 2 will explore how to ensure WSC is accessible to patients from different ethnic minority communities and socioeconomic groups. In stage 2 (months 10-39), implementation will be evaluated using a quasi-experimental design: an interrupted time series. In work package 3 we will measure outcomes in current practice 12 months before implementation using routinely collected data. Using the Implementation Strategy we will introduce WSC within the endocrine departments of the 4 NHS Trusts allowing a 3-6 month embedding period before measuring outcomes in a 12 month post implementation period. The primary outcome is the number of usable WSC test results as a proportion of requested AI tests. We will undertake a process evaluation (work package 4) and an economic evaluation (work package 5). In stage 3 (months 37-42) work package 6, we will refine the Implementation Strategy for use within the NHS. Anticipated impact & dissemination Introducing WSC across the NHS could reduce treatment burden for patients, shift care from hospital to home, and save the NHS an estimated £24M per year. We will use the influence of our highly connected clinical team to disseminate findings and maximise rapid and widespread adoption of WSC in the NHS.
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