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OpenTrials
Completed

NCT Number: NCT05838196

Service Development of POCUS in the IBD Clinic

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London Hospitals NHS Trust

London, NW1 2PG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • New patients with high clinical suspicion of IBD
  • Known UC/IBD-U and possible flare
  • Known Crohn's and possible flare
  • Known IBD and assessing response to a new medication or following surgery
  • Known IBD and clinician planning endoscopic or radiological investigations

Exclusion criteria

  • Inflammatory bowel disease limited to proctitis with no clinical suspicion of extension

Treatment and study plan

Point-of-care ultrasound

Diagnostic Test

Point-of-care ultrasound performed during clinic appointment

Primary outcomes

  1. Compare time to definitive IBD-related treatment initiation with the use of POCUS compared to standard of care

    Time frame: 6 months

    Time in days for when a new medication is started, dose changed, medication stopped, or surgery performed following the clinic appointment

Secondary outcomes

  1. Does point of care ultrasound change clinical decision making in the IBD clinic

    Time frame: Immediate

    Does the clinical decision made before ultrasound differ from that following ultrasound.

  2. Compare sensitivity and specificity of POCUS to identify active disease with standard of care investigations (MRI, ultrasound, endoscopy)

    Time frame: 6 months

    Using formalised imaging or endoscopy as gold standard for determining disease activity, compare findings on POCUS to determine sensitivity and specificity

  3. Compare healthcare resource utilisation including outpatient appointments, need for further investigations and admissions in patients receiving POCUS or standard of care

    Time frame: 1 year

    Using NHS cost tariffs, estimated costs for participants following standard of care to those receiving POCUS over the year following enrolment

  4. Compare findings at POCUS when performed by a gastroenterologist or a radiologist

    Time frame: 6 months

    POCUS will be performed by gastroenterologists or radiologist and outcomes on sensitivity/specificity will be compared between the two

  5. Compare clinical disease activity scores when POCUS is used compared with standard of care

    Time frame: 6 months

    Using disease activity score questionnaires (HBI (If Crohn's disease) or SCCAI (If ulcerative Colitis)) at baseline and six months.

  6. Compare use of steroids with POCUS compared with standard of care

    Time frame: 1 year

    Number of courses of steroids and total steroid dose over the duration of the trial

  7. Compare haemaglobin levels when POCUS is used compared with standard of care

    Time frame: 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

  8. Compare CRP levels when POCUS is used compared with standard of care

    Time frame: 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

  9. Compare Platelets when POCUS is used compared with standard of care

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 1, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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