A practice change for patients with severe chronic, clinically unexplained gastrointestinal symptoms: A randomised, controlled intervention to assess efficacy and cost-effectiveness

More than 1 out of 3 Australians suffers from chronic or relapsing gastrointestinal symptoms. In >50% of these patients, symptoms remain medically unexplained after diagnostic workup and based upon the Rome Criteria a functional gastrointestinal disorder (FGID) is diagnosed. Many FGID patients in primary care experience treatment failures and are subsequently referred to specialists and hospitals for further management. In the subsequent “typical” face-to-face office-based model of care, much of the time is spent gathering and reviewing patient information. Often, patients disclose information in bits and pieces at different time points during follow-up consultations and this requires re-targeting of the diagnostic and treatment options ideally involving a multidisciplinary approach. Therapeutic interventions (including life-style, diet, or psychological) are delivered depending upon local availability or clinicians’ preference. Systematic use of information and communication technology in combination with integrated electronic medical records can be used to support evidence-based decision making and delivery of health care services for these patients. The development and implementation of telehealth delivered integrated care approaches for patients with FGID have been accelerated due to the COVID-19 pandemic. This project aims to validate efficacy and determine cost-effectiveness of this practice change for patients with severe chronic unexplained gastrointestinal symptoms. We will compare in a randomised prospective study the standard best-practice face-to-face clinical models of care with a structured technology enabled (mostly) remotely delivered treatment approach. This is facilitated by structured assessment of gastrointestinal symptoms and psychological comorbidities, telehealth delivered interventions, molecular techniques to validate dietary interventions and decision support systems.