Service Development of POCUS in the IBD Clinic

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 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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Diagnostic test: Point-of-care ultrasound

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participant will follow standard of care
Experimental: 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	Diagnostic test: Point-of-care ultrasound; Point-of-care ultrasound performed during clinic appointment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: William Blad, BM BCh, University College London Hospitals Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Intestinal ultrasound
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 155436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No