NCT04770766

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

4.1 years

First QC Date

February 12, 2021

Last Update Submit

September 16, 2025

Conditions

Keywords

Emergency Service, HospitalWorkforceProfessional Autonomynon-medical practitionersHealth Services Research

Outcome Measures

Primary Outcomes (1)

  • Re-attendance

    Re-attendance at the Emergency department following the index event

    7 days

Secondary Outcomes (8)

  • Left without being seen

    up to 8 hours

  • Time to initial assessment

    Up to 8 hours

  • Time to treatment

    Up to 8 hours

  • Total time

    Up to 8 hours

  • Clinical investigation

    Up to 8 hours

  • +3 more secondary outcomes

Other Outcomes (4)

  • Stakeholder perspectives

    Up to 6 months

  • Staff perspectives

    3 months

  • Patient satisfaction

    1 and 28 days

  • +1 more other outcomes

Study Arms (7)

Staff observation

Doctor-in-training and non-medical practitioner volunteers

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

Other: Non-medical practitioners

Case study NHS Trusts

NHS organisations with an Emergency Department participating as a case study site

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)

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

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

Other: Non-medical practitioners

Stakeholder interviews

Senior NHS clinicians, managers, commissioners and lay representatives with roles and interests in the non-medical practitioner workforce

Other: Non-medical practitioners

Interventions

All observational research activity in each cohort is related to the exposure of non-medical practitioners in the Emergency Department or Urgent Treatment Centre

All England NHS TrustsCase study NHS TrustsPatient interviewsPatient questionnairesStaff interviewsStaff observationStakeholder interviews

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St George's University Hospital NHS Foundation Trust

London, London, SW17 0QT, United Kingdom

Location

Faculty of Health, Science, Social Care and Education

Kingston, Surrey, KT2 7LB, United Kingdom

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mary Halter, PhD

    Kingston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 25, 2021

Study Start

March 1, 2021

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations