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

NHS Trust

Status: Terminated

Conditions: Crohn Disease of Small Intestine

Treatments: Other: Non-interventional study

Study type: Observational

Funder types: Other

Identifiers

NCT07157436

21GA005

Details and patient eligibility

About

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.

Full 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/

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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/

Trial design

4 participants in 1 patient group

Qualitative interview study

Description:

• 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.

Treatment:

Other: Non-interventional study