Service Development of POCUS in the IBD Clinic

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838196
• Other study ID #: 155436
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: May 2024
• Source: University College, London
• Contact: William Blad, BM BCh
• Phone: +447841581873
• Email: william.blad[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: November 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Diagnostic Test:
• Point-of-care ultrasound
Point-of-care ultrasound performed during clinic appointment

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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