Service Development of POCUS in the IBD Clinic

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Diagnostic Test: Point-of-care ultrasound

• Registration Number: NCT05838196
• Lead Sponsor: University College, London

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.

Study Timeline

• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-20
• Study Start: 2023-04-24
• Study First Posted: 2023-05-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Point-of-care Ultrasound	Point-of-care ultrasound	Participant will receive point-of-care ultrasound at time of clinic appointment and clinician will use result to inform treatment decision

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University College London Hospitals NHS Trust; 🇬🇧 London, United Kingdom