Prehospital Assessment Units - a Case Control Study

Sponsor
Prehospital Center, Region Zealand (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05654909
Collaborator
(none)
10,849
1
14
775.2

Study Details

Study Description

Brief Summary

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 case-control study included data from patients assessed by the PAU between November 1st 2021, and October 1st 2022.

Controls 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Prehospital assessment unit

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. (1) 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. (2,3) The PAU can be compared with the community paramedic units. (3,4) 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. (3-5) 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. (5)

This retrospective case-control study was conducted as a quality assessment project 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 Design

Study Type:
Observational
Actual Enrollment :
10849 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Prehospital Assessment Units - a Matched Case-control Study
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Cases

Cases were patients calling 1-1-2 assigned for the prehospital assessment unit,

Procedure: 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.

Controls

Controls 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.

Outcome Measures

Primary Outcome Measures

  1. Admission within 48 hours [48 hours]

    Dichotomous variable of admission within two days after intial call

  2. Admission within 7 days [7 dats]

    Dichotomous variable of admission within seven days after intial call

Secondary Outcome Measures

  1. Admission within 6 hours [6 hours]

    Dichotomous variable of admission within 6 hours from intial call

  2. 30-day survival [30-day]

    30-day survival from initial call

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prehospital Center Næstved Denmark

Sponsors and Collaborators

  • Prehospital Center, Region Zealand

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Signe Amalie Wolthers, MD, Prehospital Center, Region Zealand
ClinicalTrials.gov Identifier:
NCT05654909
Other Study ID Numbers:
  • PHV_2022
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2022