Condition category
Not Applicable
Date applied
12/09/2020
Date assigned
17/09/2020
Last edited
18/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background
Ontario’s emergency departments (EDs) have increasingly become burdened with demand for emergency services exceeding most EDs ability to provide quality and timely care. Despite advancements in administrative, political, health policy, access to primary care, and public awareness initiatives, EDs have continued to remain overutilized with increases to the time of initial physician assessment, care received, discharge, and overall wait time for patients. Additionally, EDs have become congested by patients with non-emergency complaints, when alternative care for their conditions may be more appropriate, would strengthen patient relationships with primary care physicians and are more cost-effective.

Ambulance transport diversion from ED destinations to sub-acute centres does not exist in Ontario, Canada for patients with non-emergency conditions who call for emergency services (911). Conceptually this model of care could improve several healthcare domains such as hospital use, patient navigation, quality of care, or ambulance use. Use of urgent care centres and other sub-acute healthcare units have been shown to decrease the proportion of low acuity (non-emergency) ED cases and provides similar services to EDs but in a limited capacity.

Currently, there is not a gold standard to classify non-emergency patients whose ED visits could be potentially preventable for transport to sub-acute centres. Therefore, an original classification is required to increase the understanding of categorizing ambulance transported patients and to inform future clinical decisions, based on in-hospital outcomes and interventions received. This study aims to develop such a classification.

Who can participate?
Ontario physicians who practice in an emergency department and/or primary care centres.

What does the study involve?
This study will use a RAND/UCLA modified Delphi methodology to survey and assess the consensus of a technical expert committee, composed of Ontario physicians, through a two-phase development and evaluation model. Phase one will determine which ED interventions could be conducted in primary care sub-acute centre destinations and phase two will evaluate the criterion for inclusion in a PriCARE classification that is appropriate as a primary care-like visit and could yield the highest specificity of a same-day discharge ED visit, with no hospital admission or mortality.

What are the possible benefits and risks of participating?
The results of this study will add a new classification to the scientific literature for categorizing patients who are transported to the ED and receive primary care-like visits. This classification will potentially support further research into new models of preventative care as well as ambulance diversion to sub-acute centres. In addition, this study will provide patient-level evidence to inform prospective research to validate the PriCARE classification

No known risks to experts are anticipated as a result of participating in this study. The technical expert committee will be asked to rank secondary data interventions and variations of a classification in a two-phase RAND/UCLA modified Delphi study design. The investigators do not anticipate this being difficult to rate as the experts are practicing physicians.

Where is the study run from?
McMaster University (Canada)

The participating experts of the technical expert committee will be contributing through online means only (questionnaires, video debriefing).

When is the study starting and for how long?
From May 2020 to August 2021

Who is funding the study?
Big Data and Geriatric Models of Care, McMaster University (Canada)

Who is the main contact?
Mr Ryan P Strum
strumr@mcmaster.ca

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ryan Strum

ORCID ID

https://orcid.org/0000-0003-1902-4734

Contact details

1280 Main Street West
CLRB 106
Hamilton
L8S 4L8
Canada
+1 416-898-1160
strumr@mcmaster.ca

Type

Scientific

Additional contact

Dr Andrew Costa

ORCID ID

Contact details

1280 Main Street West
CLR-219
Hamilton
L8S 4K1
Canada
+1 (905) 525-9140, ext. 22067
acosta@mcmaster.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Development of the PriCARE classification for potentially preventable ambulance emergency department visits: a RAND/UCLA modified Delphi study protocol

Acronym

PriCARE

Study hypothesis

A new paramedic-relevant classification for potentially preventable ED visits is valid and reliable and can be used to support new models of preventative care as well as ambulance diversion to sub-acute levels of care.

Ethics approval

Granted a waiver exemption 29/07/2020, Hamilton Integrated Research Ethics Board (HiREB; 293 Wellington Street, Suite 102, Hamilton ON, L8L 8E7; +1 905 521 2100; trimks@mcmaster.ca), ref: 2020-11451

Study design

Two-phase RAND/UCLA modified Delphi study design

Primary study design

Other

Secondary study design

Trial setting

Internet

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Canadian Classification of Health Interventions conducted in Ontario emergency departments, as reported in the National Ambulatory Care Reporting System database on patients with non-emergent acuities.

Intervention

This study will use a RAND/UCLA modified Delphi methodology to assess the consensus of a technical expert committee through a two-phase development and evaluation model. Phase one will determine which Emergency Department (ED) interventions could be conducted in primary care sub-acute centre destinations and phase two will evaluate the criterion for inclusion in a PriCARE classification that is appropriate as a primary care-like visit and could yield the highest specificity of a same-day discharge ED visit, with no hospital admission or mortality.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. The consensus of the technical expert committee of ED interventions in phase one
2. The consensus of the technical expert committee of a PriCARE classification in phase two

Secondary outcome measures

1. Analysis of the PriCARE classification that achieves concordance amongst the technical expert committee, analyzed in the National Ambulatory Care Reporting System ED database from years 2014-2018 for associations of patient-level characteristics with a PriCARE classification, in phase two

Overall trial start date

01/05/2020

Overall trial end date

01/08/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Experienced physicians with extensive knowledge in emergency medicine or primary care
2. Active healthcare physician who, at the time of the study, is involved in the care of patients in an emergency department and/or primary care centre

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

14-18

Participant exclusion criteria

1. Non-physician clinicians
2. Physicians not practicing in an emergency or primary care context
3. Physicians not practicing in Canada.

Recruitment start date

15/10/2020

Recruitment end date

15/11/2020

Locations

Countries of recruitment

Canada

Trial participating centre

McMaster University
1280 Main Street West
Hamilton
L8S 4L8
Canada

Sponsor information

Organisation

McMaster University

Sponsor details

1280 Main Street West
Hamilton
L8S 4L8
Canada
+1 905-525-9140
hrmasst@mcmaster.ca

Sponsor type

University/education

Website

https://healthsci.mcmaster.ca/hei-hrm

Funders

Funder type

University/education

Funder name

McMaster University

Alternative name(s)

McMaster, The McMaster University, Mac, McMaster Univ.

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

Canada

Results and Publications

Publication and dissemination plan

The study results will be published in a scientific peer-reviewed journal and presented at various conferences.

IPD sharing statement:
The data collected from the technical expert committee will be analyzed and published as aggregate results; no individual scores will be reported. Each expert participant will be assigned a unique identification (ID) number, and all data will be stored under this ID. No participant level data will be shared with anyone outside of the participant themselves, and all other data from this study will be presented as aggregate. No personal information or patient level data is to be transferred within the study. All participants of this study will have their anonymity maintained by the researchers. All documents will be stored securely and are only assessable by the investigators.

Intention to publish date

01/10/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/09/2020: Internal review. 17/09/2020: Trial’s existence confirmed by Hamilton Integrated Research Ethics Board.