Service Development of POCUS in the IBD Clinic

Study Overview
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Brief Summary
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Study to determine whether the use of an ultrasound completed during an inflammatory bowel disease (IBD) clinic will speed up diagnosis, treatment initiation, reduce complications, save money and reduce investigations compared with our current standard of care.

Detailed Description
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After being provided with study information and providing written informed consent, participants attending the inflammatory bowel disease clinic will be randomised to standard of care or to receiving an ultrasound during the clinic appointment. This ultrasound result will be used to determine treatment decisions. Participants will have a 6 month follow-up to capture outcome data and further medical record review will be conducted at one year.

Official Title
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Does the Use of Point of Care Ultrasound During Inflammatory Bowel Disease Clinic Appointments Change Management, Speed up Treatment Decisions and Save Money: a Feasibility and Service Development Study

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Diagnostic Test: Point-of-care ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 16 years or above Attending IBD clinic face-to-face Able to give informed consent. Belonging to one of the following groups: New patients with high clinical suspicion of IBD Known UC/IBD-U and possible flare Known Crohn's and possible flare Known IBD and assessing response to a new medication or following surgery Known IBD and clinician planning endoscopic or radiological investigations Exclusion Criteria: Inflammatory bowel disease limited to proctitis with no clinical suspicion of extension

Ages Eligible for Study
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Minimum Age: 16 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participant will follow standard of care | |
| Experimental: Point-of-care Ultrasound<br>Participant will receive point-of-care ultrasound at time of clinic appointment and clinician will use result to inform treatment decision | Diagnostic Test: Point-of-care ultrasound<br>* Point-of-care ultrasound performed during clinic appointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare time to definitive IBD-related treatment initiation with the use of POCUS compared to standard of care | Time in days for when a new medication is started, dose changed, medication stopped, or surgery performed following the clinic appointment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does point of care ultrasound change clinical decision making in the IBD clinic | Does the clinical decision made before ultrasound differ from that following ultrasound. | Immediate | 
| Compare sensitivity and specificity of POCUS to identify active disease with standard of care investigations (MRI, ultrasound, endoscopy) | Using formalised imaging or endoscopy as gold standard for determining disease activity, compare findings on POCUS to determine sensitivity and specificity | 6 months | 
| Compare healthcare resource utilisation including outpatient appointments, need for further investigations and admissions in patients receiving POCUS or standard of care | Using NHS cost tariffs, estimated costs for participants following standard of care to those receiving POCUS over the year following enrolment | 1 year | 
| Compare findings at POCUS when performed by a gastroenterologist or a radiologist | POCUS will be performed by gastroenterologists or radiologist and outcomes on sensitivity/specificity will be compared between the two | 6 months | 
| Compare clinical disease activity scores when POCUS is used compared with standard of care | Using disease activity score questionnaires (HBI (If Crohn's disease) or SCCAI (If ulcerative Colitis)) at baseline and six months. | 6 months | 
| Compare use of steroids with POCUS compared with standard of care | Number of courses of steroids and total steroid dose over the duration of the trial | 1 year | 
| Compare haemaglobin levels when POCUS is used compared with standard of care | Are there significant difference between the change in haemaglobin from baseline to six months in the POCUS group compared with standard of care | 6 months | 
| Compare CRP levels when POCUS is used compared with standard of care | Are there significant difference between the change in CRP from baseline to six months in the POCUS group compared with standard of care | 6 months | 
| Compare Platelets when POCUS is used compared with standard of care | Are there significant difference between the change in platelets from baseline to six months in the POCUS group compared with standard of care | 6 months | 
| Compare Platelets when POCUS is used compared with standard of care | Are there significant difference between the change in albumin from baseline to six months in the POCUS group compared with standard of care | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intestinal ultrasound