Clinical trial NCT05838196: Service Development of POCUS in the IBD Clinic
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Intestinal ultrasound
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 122
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare time to definitive IBD-related treatment initiation with the use of POCUS compared to standard of care
timeFrame: 6 months
Secondary outcomes:
measure: Does point of care ultrasound change clinical decision making in the IBD clinic
timeFrame: Immediate
measure: Compare sensitivity and specificity of POCUS to identify active disease with standard of care investigations (MRI, ultrasound, endoscopy)
timeFrame: 6 months
measure: Compare healthcare resource utilisation including outpatient appointments, need for further investigations and admissions in patients receiving POCUS or standard of care
timeFrame: 1 year
measure: Compare findings at POCUS when performed by a gastroenterologist or a radiologist
timeFrame: 6 months
measure: Compare clinical disease activity scores when POCUS is used compared with standard of care
timeFrame: 6 months
measure: Compare use of steroids with POCUS compared with standard of care
timeFrame: 1 year
measure: Compare haemaglobin levels when POCUS is used compared with standard of care
timeFrame: 6 months
measure: Compare CRP levels when POCUS is used compared with standard of care
timeFrame: 6 months
measure: Compare Platelets when POCUS is used compared with standard of care
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals NHS Trust
Study officials:
affiliation: University College London Hospitals Trust
name: William Blad, BM BCh
role: PRINCIPAL_INVESTIGATOR
References: