RecruitingACTRN12618000122257

Understanding the effects of a multidisciplinary Gastroenterology and Hepatology Integrated Care Clinic approach in patients with chronic gastrointestinal disorders: a randomised controlled trial.

The effects of a multidisciplinary Gastroenterology and Hepatology Integrated Care Clinic approach in patients with chronic gastrointestinal disorders: a randomised controlled trial.


Sponsor

Princess Alexandra Hospital

Enrollment

500 participants

Start Date

Jan 30, 2018

Study Type

Interventional

Conditions

Summary

The Department of Gastroenterology and Hepatology at the Princess Alexandra Hospital has recently established an Integrated Care Clinic as a strategy to help meet the growing demands for Gastroenterology and Hepatology outpatient services, to reduce waiting times and minimise risks to patients resulting from delayed health care management. The Integrated Care Clinic provides a multi-disciplinary approach by providing outpatient services cooperatively by GPs/specialists and nurses and well as by allied health professionals including psychologists, dieticians and exercise physiologists to manage patients with highly prevalent, but chronic conditions including patients with functional gastrointestinal disorders such as irritable bowel syndrome (IBS) as well as hepatology conditions such as non-alcoholic fatty liver disease (NAFLD). This study aims to compare the effects of standard care and the Integrated Care Clinic on the health outcomes of 500 consecutive patients presenting to an outpatient department with Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, stable Inflammatory Bowel Disease and Irritable Bowel Syndrome (IBS) in relation to psychological, dietary and activity outcome parameters.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a team-based care model called the Integrated Care Clinic helps people with common digestive and liver conditions more than standard care alone. The clinic brings together specialists, GPs, nurses, psychologists, dietitians, and exercise physiologists to manage conditions together. The study focuses on patients with non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), stable inflammatory bowel disease (IBD), or irritable bowel syndrome (IBS). Researchers want to know whether this team approach leads to better mental health, diet, and activity outcomes. You may be eligible if: - You are 18 years of age or older (up to 90 years) - You speak English - You have been assessed by a specialist at Princess Alexandra Hospital - You have been diagnosed with NAFLD, NASH, stable IBD, or IBS You may NOT be eligible if: - You do not have one of the four qualifying diagnoses - You are under 18 years old Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The Department of Gastroenterology and Hepatology at the Princess Alexandra Hospital has recently established an Integrated Care Clinic as a strategy to help meet the growing demands for Gastroenter

The Department of Gastroenterology and Hepatology at the Princess Alexandra Hospital has recently established an Integrated Care Clinic as a strategy to help meet the growing demands for Gastroenterology and Hepatology outpatient services, to reduce waiting times and minimise risks to patients resulting from delayed health care management. The Integrated Care Clinic provides a multi-disciplinary approach by providing outpatient services cooperatively by GPs/specialists and nurses and well as by allied health professionals including psychologists, dieticians and exercise physiologists to manage patients with highly prevalent, but chronic conditions including patients with functional gastrointestinal disorders such as irritable bowel syndrome (IBS) as well as hepatology conditions such as non-alcoholic fatty liver disease (NAFLD). This study is designed to compare the effects of standard care and the Integrated Care Clinic on the health outcomes of patients in relation to psychological, dietary and activity outcome parameters. 500 consecutive English-speaking patients diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH), as well as stable Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS) will be will undergo routine diagnostic work-up. Thereafter patients will be randomised to receive one of three interventions: Group One will receive the individualised integrated care model which includes standardised assessment by a Gastroenterologist or Fellow, Psychologist, Dietician and Exercise Physiologist and a Primary Care Physician (GP). Following the standardised assessment, patients in Group one will receive a multidisciplinary integrated treatment approach which will may include sessions by a Psychologist, Dietician, and Exercise Physiologist as detailed under Integrated Care Model. The number of the treatment session will be determined by the individual clinicians to meet the patients needs. After a maximum of 4 months patients with either return to standard care or discharge to their GP. Group Two will receive standard care which will include a standardised assessment and routine management by a Gastroenterologist or Hepatologist. The treatment approach will be defined during the case conference and the patients will receive in total up to ten outpatient department (OPD) consultations with specialists, psychologists or allied health staff. After these 10 consultations, the patient is either discharged to the GP or continues to receive standard care in the OPD setting if this is deemed necessary by the gastroenterologists. Group Three- Patients randomised to group three receive standard care in the OPD setting. However, relevant outcome parameters will be collected 4, 12 and 26 weeks after initiation of therapy.


Locations(1)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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ACTRN12618000122257


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