Service Development of POCUS in the IBD Clinic

University College, London122 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

122

Conditions

Inflammatory Bowel Diseases

Interventions

Point-of-care ultrasoundDIAGNOSTIC_TEST

Point-of-care ultrasound performed during clinic appointment

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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: 1. New patients with high clinical suspicion of IBD 2. Known UC/IBD-U and possible flare 3. Known Crohn's and possible flare 4. Known IBD and assessing response to a new medication or following surgery 5. Known IBD and clinician planning endoscopic or radiological investigations Exclusion Criteria: * Inflammatory bowel disease limited to proctitis with no clinical suspicion of extension

Locations (1)

University College London Hospitals NHS Trust

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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