Practice Change Trial

CRE researchers from The University of Queensland, Monash University and the Department of Gastroenterology & Hepatology at the Princess Alexandra Hospital are conducting a randomised, controlled trial in 300 people with severe gastrointestinal symptoms. The collaboration is comparing the efficacy and cost-effectiveness of diet, exercise or psychology with established service models. The project is led by Professor Gerald Holtmann with funding from an NH&MRC Ideas Grant. The effectiveness-implementation hybrid design will deliver the interventions using a combination of remote delivery with digital technology and in-person sessions. Patients will initially receive standardised assessment of symptoms and wheat intolerance. Those patients that continue to experience symptoms will then be randomised to either a) diet, b) exercise, c) cognitive behaviour therapy or d) usual care. Following the intervention and depending on their response patients will be re-randomised to either a) the conventional integrated care clinic, b) a telehealth delivered integrated care clinic or c) usual care. Efficacy will be based on GI symptom type and symptom severity and assessed using the Structured Assessment of Gastrointestinal Symptoms (SAGIS) survey. Cost-effectiveness will be determined using a cost-utility analysis assessing the cost-effectiveness and given the expected impact of the intervention on patient quality of life.

The Integrated Care Clinic (ICC) was established in 2017 in the Department of Gastroenterology & Hepatology at the Princess Alexandra Hospital for people with functional gastrointestinal disorders (FGIDs). There are a number of research projects running alongside the ICC in collaboration with The University of Queensland evaluating the safety, efficacy and cost-effectiveness of the approach.

In the clinic all patients are first assessed at baseline by a gastroenterologist who then initiates any required additional diagnostic or therapeutic measures. The therapies include:

• Psychology: Patients receive psychological therapy based on their individualised needs. This includes Cognitive- Behavioural therapy, Acceptance and Commitment Therapy, relaxation techniques, or mindfulness. Patients are provided with education regarding FGID, including an explanation of the relationships that exist between psychological factors and the gut and the rationale for psychological treatment.
• Diet: First line therapy includes basic dietary advice such as including regular meals, achieving a healthy diet and restricting dietary triggers (e.g. caffeine, alcohol). The response to the low FODMAP diet and the gluten challenge are assessed, and long-term recommendations provided.
• Exercise Physiology: Patients receive individualised and supervised aerobic and neuromuscular fitness training. Exercise programs are tailored based on the disease, co-morbidities, exercise history, preferences and barriers, to maximise patient outcomes.

Patient progress is discussed in the weekly ICC team meeting and the diagnostic and therapeutic measures coordinated. At the end of a 12-week period (with 8 – 10 consultations), a treatment plan is developed and communicated to the referring GP.