A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
Primary Purpose
Gastrointestinal Diseases, Irritable Bowel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing
a) consultant-led outpatient clinic or b) a integrated care clinic
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Diseases
Eligibility Criteria
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
Sites / Locations
- Princess Alexandra HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Preconsultation Intervention
Consultation Intervention
Arm Description
Pre-consultation intervention includes 4 arms ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing)
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.
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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)
Secondary Outcome Measures
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.
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.
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.
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.
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
Microbiome
Total abundance and relative abundance of specific phyla of the microbiome
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..'
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..'
Full Information
NCT ID
NCT05274854
First Posted
February 7, 2022
Last Updated
June 26, 2023
Sponsor
The University of Queensland
Collaborators
Princess Alexandra Hospital, Brisbane, Australia, Macquarie University, Australia
1. Study Identification
Unique Protocol Identification Number
NCT05274854
Brief Title
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
Official Title
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Queensland
Collaborators
Princess Alexandra Hospital, Brisbane, Australia, Macquarie University, Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases, Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The outcomes assessor will be blinded to the treatment groups.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preconsultation Intervention
Arm Type
Experimental
Arm Description
Pre-consultation intervention includes 4 arms ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing)
Arm Title
Consultation Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
a) consultant-led outpatient clinic or b) a integrated care clinic
Intervention Description
Consultation intervention consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic
Primary Outcome Measure Information:
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 0
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 8
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 16
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 20
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 24
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 28
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 32
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 35
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 38
Title
Structured Assessment of Gastrointestinal Symptoms score
Description
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
Time Frame
Week 44
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 0
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 8
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 16
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 20
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 24
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 28
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 32
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 35
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 38
Title
European Quality of Life Five Dimension (EQ-5D)
Description
The EQ-5D is a preference-based health related Quality of Life measure. The maximum score of 1 indicates the best health state
Time Frame
Week 44
Title
Cost effectiveness
Description
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)
Time Frame
Week 0
Title
Cost effectiveness
Description
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)
Time Frame
Week 8
Title
Cost effectiveness
Description
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)
Time Frame
Week 16
Title
Cost effectiveness
Description
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)
Time Frame
Week 28
Title
Cost effectiveness
Description
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)
Time Frame
Week 44
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Week 0
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Week 16
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Week 28
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Week 44
Title
Microbiome
Description
Total abundance and relative abundance of specific phyla of the microbiome
Time Frame
Week 0
Title
Microbiome
Description
Total abundance and relative abundance of specific phyla of the microbiome
Time Frame
Week 16
Title
Microbiome
Description
Total abundance and relative abundance of specific phyla of the microbiome
Time Frame
Week 28
Title
Microbiome
Description
Total abundance and relative abundance of specific phyla of the microbiome
Time Frame
Week 44
Title
Acceptance of models of care by consumers and staff
Description
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..'
Time Frame
Week 16
Title
Acceptance of models of care by consumers and staff
Description
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..'
Time Frame
Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald Holtmann, MD, PhD
Phone
61 7 3176 7792
Email
g.holtmann@uq.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Koloski, PhD
Phone
0407126897
Email
n.koloski@uq.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Holtmann, MD PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Holtmann, PhD
Phone
07 3176 7792
Email
g.holtman@uq.edu.au
First Name & Middle Initial & Last Name & Degree
Natasha Koloski, PhD
Phone
0407126897
Email
n.koloski@uq.edu.au
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified group data will be analysed and published in medical journals
Learn more about this trial
A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms
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