EmergenciesSKILLmix-EDNCT04770766
Non-medical Practitioner Workforce in the Urgent and Emergency Care System Skill-mix in England
An observational study of Emergencies, run by Kingston University at 2 sites in United Kingdom.
Trial summary
This study will explore the result of different skill-mix in ED/UTCs in England, to make recommendations about the best balance. Patient and public involvement (PPI) representatives have helped design the study. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emergencies
- What is being tested?
- Non-medical practitioners
- How many people
- 840 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Mar 2021to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population varies for each of the study components, but is encompassed within the following: * patients attended at Emergency Departments and Urgent Treatment Centres in England 2017-2022 * staff working closely with and stakeholders to the non-medical practitioner workforce in Emergency Departments and Urgent Treatment Centres in England
Who may be able to join
- All NHS trusts: - all in England
- Case study trusts: six NHS trusts in England exhibiting different non-medical practitioner to other clinician skill-mix ratios, and giving board-level consent to participation
- Stakeholders: senior NHS clinicians, managers, commissioners and lay representatives with roles and interests in the non-medical practitioner workforce
- Staff observation: non-medical practitioners and junior doctors-in-training in one of six NHS case study trusts who volunteer to being observed in practice for specified time periods
- Staff interviews: staff working with non-medical practitioners and junior doctors-in-training in one of six NHS case study trusts who volunteer to be interviewed
- Patient questionnaire: patients attending the Emergency Department in one of the six NHS case study trusts during specified study data collection periods who agree to take a questionnaire for completion
- Patient interviews: patients attending the Emergency Department in one of the six NHS case study trusts during specified study data collection periods who return a completed questionnaire and volunteer to be interviewed
Who cannot join
- Patient data outside of the study time periods
- Staff or patient volunteers in sub-groups (e.g. personal characteristics or roles) that are already represented /over-represented amongst volunteer participants
- those for whom English is difficult to understand or speak/do not have someone with them who can interpret or support.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Faculty of Health, Science, Social Care and Education
Kingston, Surrey, KT2 7LB
St George's University Hospital NHS Foundation Trust
London, London, SW17 0QT
About this study
Official title: Implementation of the Non-medical Practitioner Workforce Into the Urgent and Emergency Care System Skill-mix in England: a Mixed Methods Study of Configurations and Impact
This study will explore the result of different skill-mix in ED/UTCs in England, to make recommendations about the best balance.
Patient and public involvement (PPI) representatives have helped design the study. There will be an independent PPI panel who can feed in their views and experiences to all parts of the study. The panel will be run by an experienced patient and public involvement expert, who is a member of the core study team.
Read more
The study will be split into four phases over two-and-a-half years.
Phase One will find out in detail what the staffing models are in EDs/UTCs. The investigators will look at published research evidence and at NHS public documents, and will interview regional and national senior NHS clinicians, managers, commissioners and lay representatives. Then, information about staff which is already collected regularly across England will be analysed for patterns. What non-medical practitioners do and how independently they work in two different ED/UTCs will also be examined. The panel of patient and public involvement representatives and a panel of non-medical practitioners will help interpret these findings. The study will develop a system for classifying 'skill-mix' in each organisation and a way to measure how much support and supervision non-medical practitioners need.
Phase Two will look at figures regularly collected from all NHS Trusts in England between 2017 and 2021, to assess whether different skill mixes lead to different patient outcomes. The number of patients who return again to the ED within a week is the primary outcome.
Phase Three will involve looking in detail in six ED/UTCs. The investigators will collect in depth local data to add to the national data we looked at in Phase Two. This will include looking closely at staff records and patients' clinical records to illustrate more detail about skill-mix in the organisations and the outcomes for patients. The study plans to gauge how independently the types of practitioners assess and treat patients and to also survey and interview patients so that their experience can be understood, alongside the views of staff who will also be interviewed.
Phase Four will pull all of the results together. The panels of patient and public involvement representatives and non-medical practitioners will help with this synthesis. The study aims to make recommendations on skill-mix and levels of independence that will deliver the best outcomes for patients, for staff and for the NHS.
Read the detailed description
Primary research question
What is the impact of different non-medical practitioner skill-mix in Emergency Departments (ED) and Urgent Treatment Centres (UTC) in acute hospitals on patient and service processes and outcomes?
Background
Increasing demand for emergency and urgent care has occurred alongside staffing shortage, particularly of doctors. Re-shaping of the workforce has resulted, including the introduction of non-medical practitioners (NMPs), such as nurse practitioners and physician associates. Despite 20 years of NMPs in EDs, there is limited evidence of effectiveness of individual roles, and none as to appropriate skill-mix of staff, at what level of independence from senior medical staff.
Aim
To explore how NMPs are being deployed and the impact of different skill-mix including NMPs in EDs and UTCs on patient experience, quality of care, clinical outcomes, activity, staff experience and costs in acute NHS trusts in England, in order to inform workforce decisions of clinicians, managers and commissioners.
Methods
A mixed methods study will be conducted in three phases.
Phase One (months 1-12) aims to describe the rationale for, and configurations of, the NMP workforce in EDs/UTCs in England, and to develop analytical tools.
- The investigators will undertake and publish a scoping literature and policy review on NMP development and skill-mix outcomes, informed by interviews with senior NHS clinicians, managers, commissioners and lay representatives (Work package [WP] 1)
- NHS Digital and NHS Benchmarking national data, 2017-2021 will be used to describe quantitatively the NMP and other clinical workforce (skill-mix); and observation (WP2) will enable qualitative description of the level of independence/supervision of NMPs and doctors.
- WP1 and WP2 results will be triangulated in consultative activities with patient and public and NMP representatives, and the independent study steering committee, to develop three analytical tools: a skill-mix ratio classification, a quantitative measure of independence and supervision, and a logic model for NMP skill-mix (WP3).
Phase two (months 13-18) aims to utilise the analytical tools to assess the impact of skill-mix ratios on national ED/UTC indicators of quality.
•The investigators will conduct and publish a quasi-experimental study of associations of skill-mix ratio classifications with our primary outcome (rate of unplanned return to the ED/UTC in seven days, a proxy for clinical safety), secondary outcomes (national indicators of ED/UTC quality and performance), and cost-effectiveness. (WP4)
Phase three (months 13-24) aims to explain the effectiveness and acceptability of skill-mix ratios through investigation in six local-level case study sites.
- The WP4 analysis will be repeated with added precise local quantitative data on NMP types (trust management information), controlling for level of independence/supervision of the clinician (collected via structured observation). Patient satisfaction will be added as an outcome, collected prospectively via questionnaire (WP5).
- The experience of including NMPs in the skill-mix will be investigated through qualitative interviews with patients and staff (WP6).
In Phase four (months 25-30) the investigators will prepare a synthesis of findings, using the logic model, for structured discussion at a stakeholder event to prepare recommendations and outputs.
Timelines for delivery
The study will take place from March 2021 to August 2023.
Anticipated impact and dissemination
The research will generate new knowledge and understanding of optimum/most effective/impact of different skill-mix outcomes to translate into workforce models with our NHS partners. Commissioners, clinicians and managers will be able to assess their local skill-mix in relation to the guidance on (optimum) skill-mix outcomes. Dissemination throughout the study will include policy briefings, academic outputs, bite-size findings, conference presentations and social and mainstream media routes accessible to stakeholders.
- Conditions
- Emergencies
- Being tested
- Non-medical practitioners
- Keywords
- Emergency Service, Hospital, Workforce, Professional Autonomy, non-medical practitioners, Health Services Research
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-medical practitionersOther
All observational research activity in each cohort is related to the exposure of non-medical practitioners in the Emergency Department or Urgent Treatment Centre
| Study group | Role | What they receive |
|---|---|---|
| Staff observation | Doctor-in-training and non-medical practitioner volunteers Receives: Other: Non-medical practitioners | |
| Patient questionnaires | Patients attending the Emergency Department of one of six NHS trusts participating in the research as a case study Receives: Other: Non-medical practitioners | |
| Case study NHS Trusts | NHS organisations with an Emergency Department participating as a case study site Receives: Other: Non-medical practitioners | |
| All England NHS Trusts | NHS Trusts whose Emergency Department (n=183) records data is held by NHS Digital and will be provided anonymously/without individual patient consent (these anticipated hundreds of thousands of records are not included in the enrolled patient numbers) Receives: Other: Non-medical practitioners | |
| Patient interviews | Patients attending the Emergency Department of one of six NHS trusts participating in the research as a case study and volunteering to take part in an interview following completion of the patient questionnaire Receives: Other: Non-medical practitioners | |
| Staff interviews | Staff working in the Emergency Department of one of six NHS trusts participating in the research as a case study and volunteering to take part in an interview Receives: Other: Non-medical practitioners | |
| Stakeholder interviews | Senior NHS clinicians, managers, commissioners and lay representatives with roles and interests in the non-medical practitioner workforce Receives: Other: Non-medical practitioners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-attendance
Re-attendance at the Emergency department following the index event
Measured: 7 days
Secondary outcomes (8)
Left without being seen
Left Emergency Department before being seen for treatment
Measured: up to 8 hours
Time to initial assessment
Time from patient arrival to being assessed by a clinician
Measured: Up to 8 hours
Time to treatment
Time from patient arrival to being treated by a clinician
Measured: Up to 8 hours
Total time
Time from patient arrival to leaving the Emergency Department
Measured: Up to 8 hours
Clinical investigation
Clinical investigations recorded by the attending clinician in the Emergency Department
Measured: Up to 8 hours
Treatment code
Treatments recorded using a code by the attending clinician in the Emergency Department
Measured: Up to 8 hours
Onward referral /treatment complete
Patient's next destination recorded in the Emergency Department
Measured: Up to 8 hours
Cost
Staff unit costs
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kingston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, St George's University Hospitals NHS Foundation Trust, Surrey and Sussex Healthcare NHS Trust, University of Surrey, Royal Holloway University
- Responsible party
- Sponsor
- Investigators
- Mary Halter, PhD, Principal investigator, Kingston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770766
- Sponsor's protocol ID
- NIHR131356
- Acronym
- SKILLmix-ED
- Status last verified
- Sep 2025
- First submitted
- 12 Feb 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Non-medical Practitioner Workforce Into the Urgent and Emergency Care System Skill-mix in England: a Mixed Methods Study of Configurations and Impact
- ClinicalTrials.gov ID
- NCT04770766
- Acronym / sponsor ID
- SKILLmix-ED / NIHR131356
- Conditions
- Emergencies
- Keywords
- Emergency Service, Hospital, Workforce, Professional Autonomy, non-medical practitioners, Health Services Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Kingston UniversityUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, St George's University Hospitals NHS Foundation Trust, Surrey and Sussex Healthcare NHS Trust, University of Surrey, Royal Holloway University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 25 Feb 2021 (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 will explore the result of different skill-mix in ED/UTCs in England, to make recommendations about the best balance.
Patient and public involvement (PPI) representatives have helped design the study. There will be an independent PPI panel who can feed in their views and experiences to all parts of the study. The panel will be run by an experienced patient and public involvement expert, who is a member of the core study team.
The study will be split into four phases over two-and-a-half years.
Phase One will find out in detail what the staffing models are in EDs/UTCs. The investigators will look at published research evidence and at NHS public documents, and will interview regional and national senior NHS clinicians, managers, commissioners and lay representatives. Then, information about staff which is already collected regularly across England will be analysed for patterns. What non-medical practitioners do and how independently they work in two different ED/UTCs will also be examined. The panel of patient and public involvement representatives and a panel of non-medical practitioners will help interpret these findings. The study will develop a system for classifying 'skill-mix' in each organisation and a way to measure how much support and supervision non-medical practitioners need.
Phase Two will look at figures regularly collected from all NHS Trusts in England between 2017 and 2021, to assess whether different skill mixes lead to different patient outcomes. The number of patients who return again to the ED within a week is the primary outcome.
Phase Three will involve looking in detail in six ED/UTCs. The investigators will collect in depth local data to add to the national data we looked at in Phase Two. This will include looking closely at staff records and patients' clinical records to illustrate more detail about skill-mix in the organisations and the outcomes for patients. The study plans to gauge how independently the types of practitioners assess and treat patients and to also survey and interview patients so that their experience can be understood, alongside the views of staff who will also be interviewed.
Phase Four will pull all of the results together. The panels of patient and public involvement representatives and non-medical practitioners will help with this synthesis. The study aims to make recommendations on skill-mix and levels of independence that will deliver the best outcomes for patients, for staff and for the NHS.
Detailed description
Primary research question
What is the impact of different non-medical practitioner skill-mix in Emergency Departments (ED) and Urgent Treatment Centres (UTC) in acute hospitals on patient and service processes and outcomes?
Background
Increasing demand for emergency and urgent care has occurred alongside staffing shortage, particularly of doctors. Re-shaping of the workforce has resulted, including the introduction of non-medical practitioners (NMPs), such as nurse practitioners and physician associates. Despite 20 years of NMPs in EDs, there is limited evidence of effectiveness of individual roles, and none as to appropriate skill-mix of staff, at what level of independence from senior medical staff.
Aim
To explore how NMPs are being deployed and the impact of different skill-mix including NMPs in EDs and UTCs on patient experience, quality of care, clinical outcomes, activity, staff experience and costs in acute NHS trusts in England, in order to inform workforce decisions of clinicians, managers and commissioners.
Methods
A mixed methods study will be conducted in three phases.
Phase One (months 1-12) aims to describe the rationale for, and configurations of, the NMP workforce in EDs/UTCs in England, and to develop analytical tools.
- The investigators will undertake and publish a scoping literature and policy review on NMP development and skill-mix outcomes, informed by interviews with senior NHS clinicians, managers, commissioners and lay representatives (Work package [WP] 1)
- NHS Digital and NHS Benchmarking national data, 2017-2021 will be used to describe quantitatively the NMP and other clinical workforce (skill-mix); and observation (WP2) will enable qualitative description of the level of independence/supervision of NMPs and doctors.
- WP1 and WP2 results will be triangulated in consultative activities with patient and public and NMP representatives, and the independent study steering committee, to develop three analytical tools: a skill-mix ratio classification, a quantitative measure of independence and supervision, and a logic model for NMP skill-mix (WP3).
Phase two (months 13-18) aims to utilise the analytical tools to assess the impact of skill-mix ratios on national ED/UTC indicators of quality.
•The investigators will conduct and publish a quasi-experimental study of associations of skill-mix ratio classifications with our primary outcome (rate of unplanned return to the ED/UTC in seven days, a proxy for clinical safety), secondary outcomes (national indicators of ED/UTC quality and performance), and cost-effectiveness. (WP4)
Phase three (months 13-24) aims to explain the effectiveness and acceptability of skill-mix ratios through investigation in six local-level case study sites.
- The WP4 analysis will be repeated with added precise local quantitative data on NMP types (trust management information), controlling for level of independence/supervision of the clinician (collected via structured observation). Patient satisfaction will be added as an outcome, collected prospectively via questionnaire (WP5).
- The experience of including NMPs in the skill-mix will be investigated through qualitative interviews with patients and staff (WP6).
In Phase four (months 25-30) the investigators will prepare a synthesis of findings, using the logic model, for structured discussion at a stakeholder event to prepare recommendations and outputs.
Timelines for delivery
The study will take place from March 2021 to August 2023.
Anticipated impact and dissemination
The research will generate new knowledge and understanding of optimum/most effective/impact of different skill-mix outcomes to translate into workforce models with our NHS partners. Commissioners, clinicians and managers will be able to assess their local skill-mix in relation to the guidance on (optimum) skill-mix outcomes. Dissemination throughout the study will include policy briefings, academic outputs, bite-size findings, conference presentations and social and mainstream media routes accessible to stakeholders.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Staff observation | – | Other: Non-medical practitionersDoctor-in-training and non-medical practitioner volunteers |
| Patient questionnaires | – | Other: Non-medical practitionersPatients attending the Emergency Department of one of six NHS trusts participating in the research as a case study |
| Case study NHS Trusts | – | Other: Non-medical practitionersNHS organisations with an Emergency Department participating as a case study site |
| All England NHS Trusts | – | Other: Non-medical practitionersNHS Trusts whose Emergency Department (n=183) records data is held by NHS Digital and will be provided anonymously/without individual patient consent (these anticipated hundreds of thousands of records are not included in the enrolled patient numbers) |
| Patient interviews | – | Other: Non-medical practitionersPatients attending the Emergency Department of one of six NHS trusts participating in the research as a case study and volunteering to take part in an interview following completion of the patient questionnaire |
| Staff interviews | – | Other: Non-medical practitionersStaff working in the Emergency Department of one of six NHS trusts participating in the research as a case study and volunteering to take part in an interview |
| Stakeholder interviews | – | Other: Non-medical practitionersSenior NHS clinicians, managers, commissioners and lay representatives with roles and interests in the non-medical practitioner workforce |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population varies for each of the study components, but is encompassed within the following: * patients attended at Emergency Departments and Urgent Treatment Centres in England 2017-2022 * staff working closely with and stakeholders to the non-medical practitioner workforce in Emergency Departments and Urgent Treatment Centres in England
Key inclusion criteria (7 listed)
- All NHS trusts: - all in England
- Case study trusts: six NHS trusts in England exhibiting different non-medical practitioner to other clinician skill-mix ratios, and giving board-level consent to participation
- Stakeholders: senior NHS clinicians, managers, commissioners and lay representatives with roles and interests in the non-medical practitioner workforce
- Staff observation: non-medical practitioners and junior doctors-in-training in one of six NHS case study trusts who volunteer to being observed in practice for specified time periods
- Staff interviews: staff working with non-medical practitioners and junior doctors-in-training in one of six NHS case study trusts who volunteer to be interviewed
Key exclusion criteria (3 listed)
- Patient data outside of the study time periods
- Staff or patient volunteers in sub-groups (e.g. personal characteristics or roles) that are already represented /over-represented amongst volunteer participants
- those for whom English is difficult to understand or speak/do not have someone with them who can interpret or support.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-medical practitionersAll observational research activity in each cohort is related to the exposure of non-medical practitioners in the Emergency Department or Urgent Treatment Centre | Other | All England NHS Trusts, Case study NHS Trusts, Patient interviews, Patient questionnaires, Staff interviews, Staff observation, Stakeholder interviews |
Primary outcome
Re-attendance
Time frame: 7 days
Re-attendance at the Emergency department following the index event
8 secondary outcomes
Left without being seen
Time frame: up to 8 hours
Time to initial assessment
Time frame: Up to 8 hours
Time to treatment
Time frame: Up to 8 hours
Total time
Time frame: Up to 8 hours
Clinical investigation
Time frame: Up to 8 hours
Treatment code
Time frame: Up to 8 hours
Onward referral /treatment complete
Time frame: Up to 8 hours
Cost
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Emergencies
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
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. This study is not recruiting at the moment.
Mary Halter, PhD principal investigator
Kingston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by Kingston University at 2 sites in United Kingdom.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-attendance (time frame: 7 days). 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 22 Sep 2025.