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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastrointestinal Diseases, Irritable Bowel Syndrome

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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. Patients will initially receive standardised assessment of symptoms and wheat intolerance. Those patients that continue to experience symptoms will then be randomised to one of four pre-consultation interventions followed by randomisation to one of two consultation interventions conditional on their response to the initial intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preconsultation Intervention<br>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<br>* 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<br>|
| Experimental: Consultation Intervention<br>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<br>* Consultation intervention consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic<br>|

What is the study measuring?
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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 |