Implementation of Point Of Care UltraSound in the Assessment of Crohn's Disease -The POCUS Study

Terminated

• Conditions: Crohn Disease of Small Intestine

• Registration Number: NCT07157436
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief Summary

1. Explore Stakeholder perceptions of POCUS service development and implementation in the NHS in an interview Sub-study. We will assess whether stakeholders:

* Recognise the potential of POCUS for the management of small bowel CD;

* feel that it should be integrated into local services;

* feel that they have the skills/resources to deliver POCUS;

* can establish criteria for the service success of POCUS.

2. Compare the impact of POCUS and MRE on the nature of decision-making of consultant gastroenterologists and their confidence in clinical decision making.

3. Undertake care pathway analyses of POCUS and MRE service for IBD outpatients with small bowel CD.

Detailed Description

To demonstrate feasibility of implementing POCUS for the diagnosis and management of small bowel CD in adult ambulatory IBD care and identify the barriers for wide-spread NHS adoption

Objectives:

1. Explore Stakeholder perceptions of anticipated barriers and enablers to POCUS service development and implementation

2. Compare the impact of POCUS and MRE on the nature of decision-making of consultant gastroenterologists and their confidence in clinical decision making.

3. Undertake care pathway analyses of POCUS and MRE service for IBD outpatients with small bowel CD.

Outcome:

To create an implementation toolkit to facilitate widespread POCUS adoption and integration within NHS IBD clinical practice.

1. Qualitative interview study:

Inclusion criteria

* Able to give valid informed consent

* Aged 18 years or over.

* One of the following roles

* NHS Gastroenterology consultant

* NHS IBD Nurse Specialist

* NHS Consultant Radiologist

* NHS business managers working in gastrointestinal services

* Patient under the care of the NHS for small bowel CD. Exclusion criteria

* Unable to communicate clearly in verbal and written English.

2. Clinical Decision-making study Inclusion criteria

* Ability to give informed consent.

* Full time NHS Consultant Gastroenterologist (on GMC specialist register).

* Agreement to comply with the study training requirements, protocol and regulatory/ sponsor stipulations.

* Have access to local Point Of Care UltraSound (POCUS) and Magnetic Resonance Enterography (MRE) services Exclusion criteria

* Unable to access REDCap\* eCRF via NHS servers. \* https://projectredcap.org/software/

Study Timeline

• Study Start: 2021-05-26
• Status Verified: 2021-06
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Study First Submitted: 2025-08-21
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To create an implementation toolkit to facilitate widespread POCUS adoption and integration within NHS IBD clinical practice.	36 months	Total project outcome

Trial Locations

Locations (1)

Nottingham NIHR Biomedical Research Centre; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom