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Non-medical Practitioner Workforce in the Urgent and Emergency Care System Skill-mix in England (SKILLmix-ED)

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ClinicalTrials.gov Identifier: NCT04770766
Recruitment Status : Not yet recruiting
First Posted : February 25, 2021
Last Update Posted : February 25, 2021
Sponsor:
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
Information provided by (Responsible Party):
Kingston University

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.


Condition or disease Intervention/treatment
Emergencies Other: Non-medical practitioners

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Study Type : Observational
Estimated Enrollment : 372 participants
Observational Model: Cohort
Time Perspective: Other
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
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Staff observation
Doctor-in-training and non-medical practitioner volunteers
Other: Non-medical practitioners
All observational research activity in each cohort is related to the exposure of non-medical practitioners in the Emergency Department or Urgent Treatment Centre

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

Case study NHS Trusts
NHS organisations with an Emergency Department participating as a case study site
Other: Non-medical practitioners
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 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
All observational research activity in each cohort is related to the exposure of non-medical practitioners in the Emergency Department or Urgent Treatment Centre

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

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

Stakeholder interviews
Senior NHS clinicians, managers, commissioners and lay representatives with roles and interests in the non-medical practitioner workforce
Other: Non-medical practitioners
All observational research activity in each cohort is related to the exposure of non-medical practitioners in the Emergency Department or Urgent Treatment Centre




Primary Outcome Measures :
  1. Re-attendance [ Time Frame: 7 days ]
    Re-attendance at the Emergency department following the index event


Secondary Outcome Measures :
  1. Left without being seen [ Time Frame: up to 8 hours ]
    Left Emergency Department before being seen for treatment

  2. Time to initial assessment [ Time Frame: Up to 8 hours ]
    Time from patient arrival to being assessed by a clinician

  3. Time to treatment [ Time Frame: Up to 8 hours ]
    Time from patient arrival to being treated by a clinician

  4. Total time [ Time Frame: Up to 8 hours ]
    Time from patient arrival to leaving the Emergency Department

  5. Clinical investigation [ Time Frame: Up to 8 hours ]
    Clinical investigations recorded by the attending clinician in the Emergency Department

  6. Treatment code [ Time Frame: Up to 8 hours ]
    Treatments recorded using a code by the attending clinician in the Emergency Department

  7. Onward referral /treatment complete [ Time Frame: Up to 8 hours ]
    Patient's next destination recorded in the Emergency Department

  8. Cost [ Time Frame: 1 hour ]
    Staff unit costs


Other Outcome Measures:
  1. Stakeholder perspectives [ Time Frame: Up to 6 months ]
    Qualitative exploration of the factors and rationale influencing current and future ED/UTC workforce configurations and the inclusion of different types of NMPs

  2. Staff perspectives [ Time Frame: 3 months ]
    Qualitative exploration of views of staff closely related to working with NMPs

  3. Patient satisfaction [ Time Frame: 1 and 28 days ]
    Quantitative measure of patient experience of being attended in Emergency Departments with differing skill-mix ratios

  4. Patient perspectives [ Time Frame: 28 days ]
    Qualitative exploration of views of patients attended in Emergency Departments with differing skill-mix ratios



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770766


Contacts
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Contact: Mary Halter, PhD +44 2087250337 maryhalter@sgul.kingston.ac.uk
Contact: Vari Drennan, PhD +44 2087252339 v.drennan@sgul.kingston.ac.uk

Locations
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United Kingdom
Faculty of Health, Social Care and Education
London, United Kingdom, SW17 0RE
Contact: Mary Halter, PhD       maryhalter@sgul.kingston.ac.uk   
Contact: Vari Drennan, PhD       v.drennan@sgul.kingston.ac.uk   
Sponsors and Collaborators
Kingston University
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
Investigators
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Principal Investigator: Mary Halter, PhD Kingston University
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Responsible Party: Kingston University
ClinicalTrials.gov Identifier: NCT04770766    
Other Study ID Numbers: NIHR131356
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kingston University:
Emergency Service, Hospital
Workforce
Professional Autonomy
non-medical practitioners
Health Services Research
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes