Condition category
Not Applicable
Date applied
06/11/2017
Date assigned
04/01/2018
Last edited
04/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Pressure continues to grow on Emergency Departments (EDs) in the United Kingdom, with declining performance and adverse effects on patient outcome, safety and experience. One proposed solution is to locate general practitioner (GPs) in or alongside the ED, with a number of models introduced. Currently 40% of Beds report primary care co-location, however evidence of effectiveness is weak. There is no consensus regarding the most efficient model of care, or ever whether GPs should be employed in this way. The aims of this study are to examine the impact of GP’s working in or alongside the ED (GPED) on patient care, the primary care and acute hospital team and the wider urgent care system and the differential impact of alternative service models of GPED.

Who can participate?
Adult ED patients, their cares and staff working in ED.

What does the study involve?
This study contains three parts. The first two parts of the study builds on previous work on the current models of GPED and the impact of those models using Hospital Episode Statistics (HES) data. The third part of the study analyses study sites who are about to implement and who have already implemented a GPED model of care. Patient/Carer participants who take part in the study take part in a short interview (up to 30 minutes) with a researcher about their views and experiences of ED, with permission they may also have their care in ED observed. This takes place for a period of 1-2 weeks. Those sites who have not yet implemented the GPED model of care, these interviews and observations are done before the model of care is implemented and 12 months after. Surveys are also administered to ED staff to assess their perspectives on the models of care. For established sites this is administered once, for prospective sites this are administered before GPED implementation, and 12 months later.

What are the possible benefits and risks of participating?
There are no direct benefits to participation. Interviewing patients about their views and experiences of the Emergency Department will help to understand the effect of GPs working in the Emergency Department on patient care. It will give a more detailed understanding of the challenges and benefits of such care, and ways that it could be improved. There are no risks with participation.

Where is the study run from?
This study is being run by University of the West of England (UK) and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
October 2017 to May 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Katherine Morton

Trial website

http://www1.uwe.ac.uk/hls/research/gpedproject.aspx

Contact information

Type

Scientific

Primary contact

Dr Katherine Morton

ORCID ID

http://orcid.org/0000-0003-2413-8867

Contact details

University of the West of England
Glenside Campus
Blackberry Hill
Stapleton
Bristol
BS16 1DD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35646

Study information

Scientific title

General Practitioners and Emergency Departments (GPED): Efficient Models of Care

Acronym

Study hypothesis

The study will address the following research questions :
1. What is the impact of GP’s working in or alongside the ED (GPED) on patient care, the primary care and acute hospital team and the wider urgent care system?
2. What is the differential impact of alternative service models of GPED?

Ethics approval

East Midlands- Leicester South Research Ethics Committee , 23/08/2017, ref: 17/EM/0312

Study design

Observational; Design type: Qualitative

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Health services and delivery research, Primary sub-specialty: Health Services and Delivery Research; UKCRC code/ Disease: Generic Health Relevance/ No specific disease

Intervention

This is a mixed-methods study, comprising three work packages:

Work Package A: Mapping, Taxonomy and Interviews
This work package maps, describes and classifies current models of GPED in all EDs in England, building on previous work. Through interviews with key informant, this part of the study examines the hypotheses that underpin GPED and its anticipated benefits.

Work Package B: Quantitative Analysis of National Data
This work package measures the impact of the models of GPED identified in WP-A, compared to a no-GPED model, using routinely available Hospital Episode Statistics (HES) data. It also calculates costs and consequences of the different GPED models.

Work Package C: Case Studies
Completes a detailed mixed-methods analysis in ten case study sites that are about to implement (six sites), or have already implemented (four sites) a GPED model of care. Work Package C consists of semi-structured interviews and non-participant observation of consenting staff, patients and carers in ED. They are interviewed for up to 30 minutes, and also have their care/clinical practice observed for up to two hours. For established sites this data collection takes place once over a period of 1-2 weeks. For prospective sites this takes place for 1-2 weeks prior to GPED implementation, and repeated 12 months later.

A workforce survey is also be administered to the ED staff to access perspectives on current and proposed models of care. For established sites this is administered once, for prospective sites this are administered longitudinally; before GPED implementation, and 12 months later.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The number of ED attendances measured before and after GPED implementation.

Secondary outcome measures

The following are assessed using routinely collected HES data:
1. 4 hour performance
2. Unplanned ED re-attendance within 7 days
3. Mortality within 28 days after attendance
4. Emergency hospital admission
5. Zero day admission (subject to an examination of coding behaviour by hospital Trusts)

Overall trial start date

11/10/2017

Overall trial end date

30/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult patients presenting at ED
2. Carers of patients presenting at ED
3. Staff working in ED

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1048; UK Sample Size: 1048

Participant exclusion criteria

Work Package C (Qualitative)
1. Patients aged under 18 years
2. Critically ill patients. (We will be led by NHS staff who will identify patients not appropriate for inclusion in study)
3. Non-English speakers
4. Patients who lack capacity (e.g. due to cognitive impairment)

Recruitment start date

11/10/2017

Recruitment end date

30/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Luton & Dunstable University Hospital
Lewsey Road
Luton
LU4 0DZ
United Kingdom

Trial participating centre

Harrogate District Hospital
Lancaster Park Road
Harrogate
HG2 7SX
United Kingdom

Trial participating centre

St Peter’s Hospital
Guildford Road Chertsey
Lyne
KT16 0PZ
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

University of the West of England

Sponsor details

Coldharbour Lane
Bristol
BS16 1QY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Academic outputs will include a minimum of three papers, submitted to high-impact peer reviewed journals, and at least four conference presentations or workshops.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/03/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/12/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.