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Service Development of POCUS in the IBD Clinic

Primary Purpose

Inflammatory Bowel Diseases

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Point-of-care ultrasound

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Diseases focused on measuring Intestinal ultrasound

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University College London Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Point-of-care Ultrasound

Arm Description

Participant will follow standard of care

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

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

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

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.

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

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

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

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

Compare Platelets when POCUS is used compared with standard of care

Are there significant difference between the change in albumin from baseline to six months in the POCUS group compared with standard of care

Full Information

NCT ID

NCT05838196

First Posted

April 6, 2023

Last Updated

April 20, 2023

Sponsor

University College, London

1. Study Identification

Unique Protocol Identification Number

NCT05838196

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 24, 2023 (Anticipated)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases

Keywords

Intestinal ultrasound

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participant will follow standard of care

Arm Title

Point-of-care Ultrasound

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Point-of-care ultrasound

Intervention Description

Point-of-care ultrasound performed during clinic appointment

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Immediate

Title

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

Description

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

Time Frame

6 months

Title

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

Description

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

Time Frame

1 year

Title

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

Description

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

Time Frame

6 months

Title

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

Description

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

Time Frame

6 months

Title

Compare use of steroids with POCUS compared with standard of care

Description

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

Time Frame

1 year

Title

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

Description

Are there significant difference between the change in haemaglobin from baseline to six months in the POCUS group compared with standard of care

Time Frame

6 months

Title

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

Description

Are there significant difference between the change in CRP from baseline to six months in the POCUS group compared with standard of care

Time Frame

6 months

Title

Compare Platelets when POCUS is used compared with standard of care

Description

Are there significant difference between the change in platelets from baseline to six months in the POCUS group compared with standard of care

Time Frame

6 months

Title

Compare Platelets when POCUS is used compared with standard of care

Description

Are there significant difference between the change in albumin from baseline to six months in the POCUS group compared with standard of care

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

William Blad, BM BCh

Phone

+447841581873

william.blad@nhs.net

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica Broni-Tabi

jessica.broni-tabi1@nhs.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Blad, BM BCh

Organizational Affiliation

University College London Hospitals Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

University College London Hospitals NHS Trust

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Service Development of POCUS in the IBD Clinic

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