NCT05654909

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,849

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

December 8, 2022

Last Update Submit

February 14, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Admission within 48 hours

    Dichotomous variable of admission within two days after intial call

    48 hours

  • Admission within 7 days

    Dichotomous variable of admission within seven days after intial call

    7 dats

Secondary Outcomes (2)

  • Admission within 6 hours

    6 hours

  • 30-day survival

    30-day

Study Arms (2)

PAU group

The PAU group were patients calling 1-1-2 assigned for the prehospital assessment unit,

Procedure: Prehospital assessment unit

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.

Interventions

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.

PAU group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • gynaecological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prehospital Center

Næstved, Denmark

Location

Related Publications (3)

  • Andersen MS, Johnsen SP, Sorensen JN, Jepsen SB, Hansen JB, Christensen EF. Implementing a nationwide criteria-based emergency medical dispatch system: a register-based follow-up study. Scand J Trauma Resusc Emerg Med. 2013 Jul 9;21:53. doi: 10.1186/1757-7241-21-53.

    PMID: 23835246BACKGROUND
  • Christensen EF, Bendtsen MD, Larsen TM, Jensen FB, Lindskou TA, Holdgaard HO, Hansen PA, Johnsen SP, Christiansen CF. Trends in diagnostic patterns and mortality in emergency ambulance service patients in 2007-2014: a population-based cohort study from the North Denmark Region. BMJ Open. 2017 Aug 21;7(8):e014508. doi: 10.1136/bmjopen-2016-014508.

    PMID: 28827233BACKGROUND
  • Wolthers SA, Blomberg SNF, Breindahl N, Anjum S, Hagi-Pedersen D, Ersboll A, Andersen LB, Christensen HC. Association between using a prehospital assessment unit and hospital admission and mortality: a matched cohort study. BMJ Open. 2023 Sep 22;13(9):e075592. doi: 10.1136/bmjopen-2023-075592.

MeSH Terms

Conditions

PneumoniaUrinary Tract InfectionsInfectionsDigestive System DiseasesMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 16, 2022

Study Start

November 1, 2021

Primary Completion

October 31, 2022

Study Completion

January 1, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations