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Healthy VolunteersNCT06355648

Advanced Clinical Practitioners in the ED

An observational study of Healthy Volunteers, run by King's College London.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is designed to understand better how nurses, paramedics, and other healthcare professionals who have completed extra training to become Emergency Care Advanced Clinical Practitioners (EC-ACPs) work in emergency departments (EDs). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
How many people
30 participants
Where
No sites listed yet
Study dates
3 Jan 2025to 1 Jul 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The participants will work in an Emergency Department and be selected by identifying their job roles.

Who may be able to join

  • All participants must be staff members at the host site.
  • ACPs that are observed must work in the Emergency Department.
  • All staff must have consented to participate in this research.
  • Be over the age of 18.

Who cannot join

  • No exclusion criteria

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Peter Chessum, MSc contact

+44 7595931659

Peter.chessum@kcl.ac.uk

Andreas Xyrichis, PhD contact

+44 02078487306

andreas.xyrichis@kcl.ac.uk

About this study

Official title: Advanced Clinical Practitioners in the Emergency Department: a Mixed-method Study of Practice Using Resilient Health Care Principles

This study is designed to understand better how nurses, paramedics, and other healthcare professionals who have completed extra training to become Emergency Care Advanced Clinical Practitioners (EC-ACPs) work in emergency departments (EDs).

The research questions are:

Read more
  1. What is the EC-ACP's perception of assimilation into emergency care teams, what tensions are created due to the role, and what system adaptations are required to facilitate integration?

With secondary aims :

  1. What are the common organisational factors that affect the implementation of the EC-ACP workforce, and what recommendations can be made to improve Trust-wide implementation?
  2. How are EC-ACPs deployed in two contrasting emergency departments, what differences can be identified in their Work-As-Done (WAD), and how does this compare to the Work-As-Imagined (WAI) of the role?

No patient data is being collected; the participants will all be hospital staff:

  1. EC-ACP participants will be observed in practice, interviewed, or both.
  2. Staff who are not EC-ACPs but work with them will be interviewed for their thoughts on how they work together.
Read the detailed description

In the UK, a health care role has been developed called Advanced Clinical Practitioners (ACPs). ACPs work in various clinical settings, but this study focuses on those in Emergency Care. While non-medical practitioners have worked in Emergency Departments (EDs) for over 20 years, the ACP role is relatively new. Most ACPs in ED are from a nursing or paramedical background, but they can also be from other allied health professions like physiotherapy. After the base qualification, ACPs undertake a three-year master's degree with clinical portfolios. Once qualified, the goal is to create clinicians who work alongside doctors, seeing, treating, and discharging patients. Unlike previous practitioner roles, EC-ACPs treat the whole spectrum of ED patients, from minor injuries and illnesses to the sickest patients needing the highest level of care.

Observations:

The researcher will aim to shadow x5 EC-ACPs from each site (n=10) for a maximum of five hours each, totalling at least 50 hours of observation in clinical practice. Data collection will aim to capture the variation in how EC-ACPs work by observing EC-ACPs Monday-Sunday between the following hours (08:00-13:00, 13:00-18:00, 18:00-01:00, 01:00-06:00). The researcher will record their observations in the form of field notes, which will be hand-written. Field notes will later be expanded on, typed up, and pseudonymized. During this observation period, researchers may engage in informal discussions with healthcare professionals to clarify what they observe where appropriate, though these will not be audio recorded. Additionally, the researcher will not observe patients while the EC-ACP clinically assesses them. No data will be collected on any patients.

Interviews:

Semi-structured interviews will be undertaken with a range of professional stakeholders (n=20), with ten from each Trust. Interviews will be conducted using an open-ended topic guide, facilitating the exploration of the questions with the participant (Pope \& Mays, 2006; Green \& Thorogood, 2018). The topic guide will include questions regarding the history of EC-ACP integration into the emergency care team, what specific challenges were encountered, how these were overcome, and what contribution the role has made to the emergency care system from various professional perspectives. If the interview participant was involved in the observation stage of data collection, some questions were asked to clarify observations, deriving more significant insights from the data (Pope \& Mays, 2006). Interviews will accommodate the times and dates most suitable for participants. It is envisaged that the 'gatekeepers' at both workplaces will suggest safe and appropriate locations on the two sites for conducting the interviews (Green \& Thorogood, 2018). Participants will be informed that interviews will take no more than 45 minutes and will be conducted at an agreeable time. Interview data will be sent to a Kings College London-approved transcription service via secure encrypted email.

Data Analysis:

All formal interview audio recordings will be recorded using a Dictaphone voice recorder with the participant's consent. These recordings will be anonymised and transcribed using a King's College London-approved transcription service. The researcher will personally transcribe 10% of the data interview and observational data to aid familiarisation. Thematic analysis will be conducted to identify recurring themes (Braun and Clarke, 2006). During the coding process, a code book will be created with a list of codes and descriptions to accompany it. The transcripts will be anonymized and uploaded to NVivo to be thematically analysed. The analysis will focus on answering the research questions, using constructs from the conceptual frameworks to sensitize the analysis.

Keywords
Advanced Clinical Practitioners, Emergency Department, Resilient Healthcare, Ethnographic, Work-as-done, Work-as-imagined, Resilient Engineering, Socio-technical System, Complex Adaptive Systems
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06355648
Study groupRoleWhat they receive
Emergency Care Advanced Clinical PractitionersThese are nurses, paramedics, or allied health professionals who have undertaken an MSc and work in an Emergency Department.
Clinical Colleagues of ACPsThese are staff who work directly with ACPs in the ED; they may be doctors, nurses, or allied health professionals.
Non-Clinical ColleaguesThese staff work with Advanced Clinical Practitioners but not in the clinical environment. Examples may be local managers or directors of the organisation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Examine the Work-as-Done of EM-ACPs in Emergency Departments.

    Ethnographic data, including observational notes and interview transcripts will be collected and analysed using thematic analysis, underpinned by resilient healthcare theory.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start3 Jan 2025 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06355648
Sponsor's protocol ID
IRAS 337181
Status last verified
Dec 2024
First submitted
18 Mar 2024
Last updated
12 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers, run by King's College London.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peter Chessum, MSc (+44 7595931659, Peter.chessum@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Examine the Work-as-Done of EM-ACPs in Emergency Departments. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.

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