Prehospital Assessment Units - a Matched Cohort Study

February 14, 2023 updated by: Signe Amalie Wolthers, Prehospital Center, Region Zealand

This study aimed to evaluate the prehospital assessment unit (PAU) by admission within 48 hours, 7 days, respectively and on survival.

The PAU should increase focus on a patient-centered approach with the capability to make advanced assessments of patients to reduce unnecessary transportation. Further, this paramedic assessment program could positively impact the healthcare system by reducing admissions to emergency departments.

The PAU is operated by paramedics who have additional education, and they are capable of testing and monitoring certain conditions at the scene - in the home of the patients. The paramedics decide if the patient requires admission to the hospital or if the patient could stay at home. They are consulting physicians on call by phone.

This retrospective cohort study included data from patients assessed by the PAU between November 1st 2021, and October 1st 2022.

Non-PAU patients were selected from the 1-1-2 calls (the European version of 9-1-1) EMS and were collected based on the same criteria as the patients assessed by the PAU. The control ratio was 1:10 for cases to increase power. The non-PAU patients were matched on sex and age (within 5-year ranges). Matching was performed using incidence density sampling, where controls were selected for each case on the week of 1-1-2 call.

Study Overview

Detailed Description

The demand for healthcare is increasing, stressing the need for adaptive Emergency Medical Services (EMS). This development was also illustrated in a Danish cohort study from 2017. The authors reported an increase in the annual number of patients assessed by EMS by 67% between 2007 and 2014.Thus, the traditional role of paramedics is changing to establish a bridge between the community and the hospital by offering primary care services. Paramedic assessment units (PAU) were implemented in Region Zealand, Denmark in 2021 to accommodate the increased demand. The PAU should increase focus on a patient-centered approach with the capability to make advanced assessments of patients to reduce unnecessary transportation. Further, this paramedic assessment program could positively impact the healthcare system by reducing admissions to emergency departments.

While this approach is new in Denmark, variations of the approach have been implemented internationally for more than two decades.The PAU can be compared with the community paramedic units. Different community paramedic programs have arisen to address the regional requirements; different regional and national operation environments explain this regarding the population density and level of healthcare service. No exact definition is present, but these assessment programs generally focus on frail elderly and other high-needs patients.

The PAU is operated by paramedics who have additional education, and they do have point-of-care test facilities (POCT). The paramedics can monitor saturation, blood pressure and electrocardiogram, all of which are standard equipment of ambulances in Region Zealand. Further, the paramedic can measure C-reactive protein, analyse urine test strips (pH, glucose, acetoacetate, leucocytes, nitrite, protein and erythrocytes), blood glucose and analyse blood gas (pH, pO2, pCO2, lactate, sodium, potassium, calcium and creatinine).

The patients assessed by the PAU had four possible destinations: admittance to the E-Hospital, a unique regional arrangement in which the patient stays at home but is under virtual surveillance by physicians and nurses. Alternatively, the patient was admitted to the E-hospital at local acute community-based facilities. Third, the patient was admitted to the emergency department at the hospital and finally, the PAU examined the patient at home without further follow-up. The decision was made between the physicians at the E-Hospital and the paramedic on the scene.

While the evidence supporting PAU is promising, convincing data from well-designed studies focusing on the impact of PAU on health outcomes and patient safety are still being determined.

This retrospective cohort study was conducted to compare individuals treated by PAU with a control group of matched individuals not treated by PAU. Thus, the primary objective of this study was:

  • To identify patients among cases who were admitted to the emergency department within 48 hours and 7 days after consultation with the PAU, respectively.
  • Secondary, to identify patients admitted to the emergency department within 6 hours from the initial call to the medical emergency number.
  • Finally, to identify 30-day survival.

Study Type

Observational

Enrollment (Actual)

10849

Contacts and Locations

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

Study Locations

      • Næstved, Denmark
        • Prehospital Center

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients in the Region Zealand calling 1-1-2 during the study period

Description

Inclusion Criteria:

  • expectations of undergoing an uncomplicated illness progression
  • green or yellow level of triage based on the ABCDE approach (red, orange, yellow, green, blue levels of triage.

Exclusion Criteria:

  • gynaecological disease

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PAU group
The PAU group were patients calling 1-1-2 assigned for the prehospital assessment unit,
The prehospital assessment unit was developed to provide a paramedic responding by car to 1-1-2 calls in the area of Region Zealand. Further details are mentioned in the description.
non PAU group
The non PAU group were selected from the 1-1-2 calls (the European version of 9-1-1) EMS and were collected based on the same criteria as the patients assessed by the PAU. The control ratio was 1:10 for cases to increase power. Controls were matched on sex and age (within 5-year ranges). Matching was performed using incidence density sampling, where controls were selected for each case on the week of 1-1-2 call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admission within 48 hours
Time Frame: 48 hours
Dichotomous variable of admission within two days after intial call
48 hours
Admission within 7 days
Time Frame: 7 dats
Dichotomous variable of admission within seven days after intial call
7 dats

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admission within 6 hours
Time Frame: 6 hours
Dichotomous variable of admission within 6 hours from intial call
6 hours
30-day survival
Time Frame: 30-day
30-day survival from initial call
30-day

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

November 1, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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