ED Adaptive Staffing Study (FAST-ED)

March 20, 2024 updated by: Oak Valley Health

Feasibility and Evaluation of an Adaptive STaffing Model in a Community Emergency Department (FAST-ED)

Emergency Departments (EDs) across Ontario are being inundated with unprecedented high patient volumes and a staffing shortage that directly impacts patient care and flow. An area of concern among EDs is the offload zone where patients are brought in by ambulance. EMS offload time is the time it takes paramedics to transfer a patient to the appropriate area within an emergency department and give hospital staff a summary of what concerns the patient is seeking care for. There are multiple factors that may delay this time, including limited staff in the offload area to complete the transfer process due to competing patient care responsibilities. The adaptive staffing model study will look to add a primary care paramedic (PCP) or a registered nurse (RN) in the offload zone during times of high ambulance volume (August to January) to help with patient care within the offload zone. This single-centered community hospital study will evaluate the benefits of having a PCP or RN, compared to the current model, on ambulance offload times, patient safety outcomes, patient treatment times, and staff well-being using three different models of staffing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5917

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Markham, Ontario, Canada, L3P 7P3
        • Recruiting
        • Markham Stouffville Hospital
        • Contact:
        • Principal Investigator:
          • Andrew Arcand, MD
        • Principal Investigator:
          • Philip Moran, MD
        • Sub-Investigator:
          • Michelle Dimas, MSc
        • Sub-Investigator:
          • Jinal Patel, RN
        • Sub-Investigator:
          • Ainslee Smith, RN
        • Sub-Investigator:
          • Carissa Surujpaul, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will use a convenience sampling method, given that patients brought in by ambulance are at random and non-predictive.

Description

Inclusion Criteria:

  • Patients brought in by ambulance to hospitals emergency department offload area

Exclusion Criteria:

  • Patients not arriving to the hospitals emergency department offload area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Primary Care Paramedic (PCP) Block
A PCP will be staffed in the emergency department offload zone 3 days a week (Monday, Wednesday, and Friday) on a 10am - 10pm shift, in addition to the standard staffing model.
Other: Staffing model
Staffing the hospitals emergency department offload zone with a PCP or RN or current workflow.
Registered Nurse (RN) Block
An experienced emergency department RN with triage training will be staffed in the emergency department offload zone 3 days a week (Monday, Wednesday, and Friday) in a 10am - 10pm shift, in addition to the standard staffing model
Other: Staffing model
Staffing the hospitals emergency department offload zone with a PCP or RN or current workflow.
Current Workflow Block
The currently hospitals staffing models of the emergency department offload zone.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Triage Time
Time Frame: 6 months
The aim of this objective is to compare time to triage and time to transfer of care for three models of staffing.
6 months
Return to Service
Time Frame: 6 months
The aim of this objective is to determine if an adaptive staffing model during peak volumes reduces ambulance offload times and return to service.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to provider assessment
Time Frame: 6 months
6 months
Provider Feedback Survey
Time Frame: 6 months
Explore provider perceptions (ED staff and paramedics) of each model with the aim of determining which model provides better patient care during peak volumes. Participants will self-report their perceived barriers, challenges and benefits of the staffing interventions.
6 months
Time to treatment
Time Frame: 6 months
6 months
Time to disposition
Time Frame: 6 months
6 months
Number of incident reports
Time Frame: 6 months
Patient safety events
6 months
Case costing
Time Frame: 6 months
6 months
Well-being Index (questionnaire)
Time Frame: 6 months
Explore staff and paramedic well-being on intervention model
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oak Valley Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 148-2306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate data and study results will be shared via publication and conference presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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