Viewing Study NCT04770766



Ignite Creation Date: 2024-05-06 @ 3:49 PM
Last Modification Date: 2024-10-26 @ 1:58 PM
Study NCT ID: NCT04770766
Status: UNKNOWN
Last Update Posted: 2022-04-20
First Post: 2021-02-12

Brief Title: Non-medical Practitioner Workforce in the Urgent and Emergency Care System Skill-mix in England
Sponsor: Kingston University
Organization: Kingston University

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2022-04
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SKILLmix-ED
Brief Summary: This study will explore the result of different skill-mix in EDUTCs 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 EDsUTCs 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 EDUTCs 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 EDUTCs 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 EDsUTCs 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 independencesupervision 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 EDUTC 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 EDUTC in seven days a proxy for clinical safety secondary outcomes national indicators of EDUTC 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 independencesupervision 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 optimummost effectiveimpact 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None