The RELIEF-trial for patients with upper abdominal pain: study protocol for a randomized controlled trial to investigate the effectiveness of a web-based self-management tool compared with usual care for reduction of healthcare utilization and improvement of patient-reported outcomes

Dutch healthcare faces increasing demand with constrained resources. Upper abdominal pain (UAP) is a highly prevalent symptom leading to substantial healthcare utilization and costs, with over 100,000 related hospital diagnoses annually in the Netherlands. In most cases, UAP is attributable to functional dyspepsia, irritable bowel syndrome, or symptomatic gallstone disease The overlapping symptom patterns of these diseases, which generally affect similar populations, leads to difficulties in diagnosing and an increased risk of exposing patients to unnecessary interventions and increase in healthcare costs. Web-based education and lifestyle interventions are used in several high-prevalence disorders, but evidence supporting it is effectiveness for managing patients with UAP is lacking due to its heterogeneous diagnostic nature. This trial evaluates whether a web-based self-management tool can reduce healthcare utilization by improving patient education and diagnostic selection in UAP. The RELIEF-trial is a multicenter, randomized, open-label superiority trial. Adult patients referred to hospital with UAP are eligible, except those with alarm symptoms. Participants are randomized to either usual care or the RELIEF intervention. Usual care is provided at the treating physician’s discretion. The intervention group receives access to a web-based self-management tool prior to the first outpatient visit, providing structured information on UAP, treatment options, and lifestyle advice. The primary outcome is the proportion of patients who will undergo diagnostic or treatment intervention within 12 months. Secondary outcomes include time to diagnosis, outpatient clinic- or emergency room visits, pain severity, imaging use (Computed Tomography (CT) and Magnetic Resonance Imaging (MRI), morbidity and complications, and patient-reported outcomes. The RELIEF trial is the first randomized controlled trial comparing usual care with a web-based self-management tool in patients with UAP. It will assess whether web-based education improves self-management and safely reduces diagnostic and therapeutic interventions in patients without alarm symptoms. Registry: ClinicalTrials.gov. Trial registration number: NCT06002516 (ClinicalTrials.gov), Date of registration: 2023-08-21