A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms

A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness

This research project aims to test whether early interventions delivered remotely and prior to integrated care clinic appointments are effective. Patients with chronic unexplained gastrointestinal symptoms will initially undergo structured assessment of symptoms and wheat intolerance delivered remotely. Patients who continue to experience symptoms will then be randomised to a pre-consultation intervention ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) followed by randomisation to the consultation intervention ((a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial intervention.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Diseases; Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing; Behavioral: a) consultant-led outpatient clinic or b) a integrated care clinic

Detailed Description

An Effectiveness-Implementation Hybrid Design with a two stage randomisation will be used to determine and compare efficacy and cost-effectiveness of different management approaches/interventions for patients with relevant, chronic, or relapsing gastrointestinal symptoms without concerning features and on the wait list for integrated care clinic at the Princess Alexandra Hospital. Approximately 200 patients will initially receive standardised assessment of symptoms and wheat intolerance. Those patients that continue to experience symptoms will then be randomised to a pre-consultation intervention (a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) followed by randomisation to the consultation intervention (a) consultant-led outpatient clinic or b) an integrated care clinic conditional on their response to the initial intervention. Specific aims of the study include Aim 1: Determine efficacy (symptom improvement) and cost-effectiveness (quality adjusted life years) of a structured, digital technology enabled approach for the management of patients with severe functional gastrointestinal disorders as compared to established service models; Aim 2: Identify response-predictors for the pre-clinical dietary intervention, internet delivered cognitive behavior therapy, exercise physiology and the various clinical interventions; Aim 3: Define acceptance of consumers and staff for the new service model relative to established models of care and Aim 4. To determine the dietary patterns of people with functional gastrointestinal disorders who are presenting with symptoms necessary to access tertiary care and to further examine changes in diet after a range of interventions delivered by telehealth.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerald Holtmann, MD, PhD; Phone Number: 61 7 3176 7792; Email: g.holtmann@uq.edu.au
• Study Contact Backup: Name: Natasha Koloski, PhD; Phone Number: 0407126897; Email: n.koloski@uq.edu.au

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
      • Contact: Natasha Koloski, PhD; Phone Number: 0407126897; Email: n.koloski@uq.edu.au
      • Contact: Gerald Holtmann, PhD; Phone Number: 07 3176 7792; Email: g.holtman@uq.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with relevant, chronic, or relapsing gastrointestinal (GI) symptoms without concerning features and on the wait list for integrated care clinic (ICC) will be included in the study.
• Patients with severe symptoms as defined by a total Structured Assessment of Gastrointestinal Symptoms (SAGIS) score > 35
• Patients aged 18 years or older to 90 years old

Exclusion Criteria:

• Patients with 'alarm' signs or symptoms (significant unexplained weight loss, evidence for gastrointestinal bleeding, iron deficiency anaemia, new onset GI symptoms) will be triaged to undergo urgent clinical work-up before they can be considered for inclusion into the study
• Patients with mild or moderate symptoms (e.g. not requiring clinical work-up or who will likely spontaneously improve) will not be eligible for inclusion into the study and will be managed as clinically indicated.
• Patients with any comorbidities that would interfere with the objectives of these interventions will be managed via the routine clinical pathways.
• Patients with a prior history of any eating disorder, wait listed for bariatric surgery or have had bariatric surgery will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preconsultation Intervention; Pre-consultation intervention includes 4 arms ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing)	Behavioral: a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing; Pre consultation interventions consist of one of four intervention a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing
Experimental: Consultation Intervention; Consultation intervention includes 2 arms (a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial preconsultation intervention.	Behavioral: a) consultant-led outpatient clinic or b) a integrated care clinic; Consultation intervention consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 0
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 8
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 16
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 20
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 24
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 28
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 32
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 35
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 38
Structured Assessment of Gastrointestinal Symptoms score	Structured Assessment of Gastrointestinal Symptoms score: Assesses impact of various GI symptoms. SAGIS scores will be used to measure symptom type and symptom severity. Scores can range from 0 to 88. Higher scores indicate greater severity of symptoms	Week 44
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 0
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 8
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 16
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 20
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 24
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 28
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 32
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 35
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 38
European Quality of Life Five Dimension (EQ-5D)	The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state	Week 44
Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 0
Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 8
Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 16
Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 28
Cost effectiveness	To assess the cost-effectiveness and given the expected impact of the intervention on patient quality of life, a cost-utility analysis (CUA) will be conducted. The analysis will capture direct medical and non- medical costs including out-of-pocket expenses and indirect costs (e.g., lost productivity) based upon resources consumed using unit prices from standard costing resources. Quality-adjusted life-year (QALYs) gained will be weighted by their utility score (using the EQ-5D)	Week 44

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale	Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.	Week 0
Hospital Anxiety and Depression Scale	Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.	Week 16
Hospital Anxiety and Depression Scale	Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.	Week 28
Hospital Anxiety and Depression Scale	Anxiety and Depression scores from the Hospital Anxiety and Depression Scale. Scores can range from 0 to 21 for each subscale of anxiety and depression, respectively. Higher scores indicate greater frequency of anxiety and depression.	Week 44
Microbiome	Total abundance and relative abundance of specific phyla of the microbiome	Week 0
Microbiome	Total abundance and relative abundance of specific phyla of the microbiome	Week 16
Microbiome	Total abundance and relative abundance of specific phyla of the microbiome	Week 28
Microbiome	Total abundance and relative abundance of specific phyla of the microbiome	Week 44
Acceptance of models of care by consumers and staff	For the pre-consultation and the 3- months intervention period, the consumer's net promotor score ('…I would recommend the service I received to a family member or friend yes/no..') will be determined and compared. With regard to the team providing services to the patients, all members providing care will respond to the following question in relation to specific treatment groups: '...I have been able to address the patient's problems yes/no..'	Week 16
Acceptance of models of care by consumers and staff	For the pre-consultation and the 3- months intervention period, the consumer's net promotor score ('…I would recommend the service I received to a family member or friend yes/no..') will be determined and compared. With regard to the team providing services to the patients, all members providing care will respond to the following question in relation to specific treatment groups: '...I have been able to address the patient's problems yes/no..'	Week 28

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: Princess Alexandra Hospital, Brisbane, Australia; Macquarie University, Australia
• Investigators: Principal Investigator: Gerald Holtmann, MD PhD, The University of Queensland

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: APP2004495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified group data will be analysed and published in medical journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No