Healthy VolunteersNCT06355648
Advanced Clinical Practitioners in the ED
An observational study of Healthy Volunteers, run by King's College London.
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.
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
- 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 :
- 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?
- 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:
- EC-ACP participants will be observed in practice, interviewed, or both.
- 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.
- Conditions
- Healthy Volunteers
- 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 group | Role | What they receive |
|---|---|---|
| Emergency Care Advanced Clinical Practitioners | These are nurses, paramedics, or allied health professionals who have undertaken an MSc and work in an Emergency Department. | |
| Clinical Colleagues of ACPs | These are staff who work directly with ACPs in the ED; they may be doctors, nurses, or allied health professionals. | |
| Non-Clinical Colleagues | These 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.
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.
- First posted9 Apr 2024
- Study start3 Jan 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Clinical Practitioners in the Emergency Department: a Mixed-method Study of Practice Using Resilient Health Care Principles
- ClinicalTrials.gov ID
- NCT06355648
- Acronym / sponsor ID
- IRAS 337181
- Conditions
- Healthy Volunteers
- Keywords
- Advanced Clinical Practitioners, Emergency Department, Resilient Healthcare, Ethnographic, Work-as-done, Work-as-imagined, Resilient Engineering, Socio-technical System
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 3 Jan 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 :
- 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?
- 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:
- EC-ACP participants will be observed in practice, interviewed, or both.
- Staff who are not EC-ACPs but work with them will be interviewed for their thoughts on how they work together.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Emergency Care Advanced Clinical Practitioners | – | –These are nurses, paramedics, or allied health professionals who have undertaken an MSc and work in an Emergency Department. |
| Clinical Colleagues of ACPs | – | –These are staff who work directly with ACPs in the ED; they may be doctors, nurses, or allied health professionals. |
| Non-Clinical Colleagues | – | –These staff work with Advanced Clinical Practitioners but not in the clinical environment. Examples may be local managers or directors of the organisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will work in an Emergency Department and be selected by identifying their job roles.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Examine the Work-as-Done of EM-ACPs in Emergency Departments.
Time frame: 12 months
Ethnographic data, including observational notes and interview transcripts will be collected and analysed using thematic analysis, underpinned by resilient healthcare theory.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.