The Pre-POCT-Non-Conveyance Trial: Prehospital Point-of-Care Testing to Support Non-Conveyance Decisions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Denmark Region
About this trial
The goal of this clinical trial is to evaluate whether rapid blood tests performed in the ambulance can be implemented in routine prehospital assessment of adults who are initially considered for transport to hospital. Ambulance clinicians frequently assess adults who are transported to hospital but discharged shortly after arrival without requiring advanced diagnostic testing or treatment.
In this study, researchers will examine whether adding rapid point-of-care blood testing (POCT) at the scene supports ambulance clinicians and Emergency Medical Dispatch Centre (EMDC) physicians in making more informed decisions about hospital conveyance. POCT provides rapid measurements of biomarkers including infection markers, electrolytes, kidney function, blood counts, and total carbon dioxide, a proxy measure related to acid-base status.
Ten ambulance clusters will participate in a matched, cluster-randomized design. Half will provide standard care, and half will have access to POCT following consultation with an EMDC physician in patients who would otherwise be considered for hospital transport.
The main question is whether prehospital POCT can be performed, documented, and made available before the final conveyance decision in routine ambulance-based assessment. The study will also examine whether access to POCT is associated with a higher proportion of patients remaining at home rather than being transported to hospital.
Safety outcomes will include hospital admission within 24 hours among non-conveyed patients, short-stay hospitalization, intensive care unit (ICU) admission, and 30-day mortality.
This study will evaluate the implementation of POCT-supported decision-making in prehospital care and explore whether it may increase non-conveyance without compromising patient safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥18 years
Emergency call or general practitioner-commissioned ambulance dispatch following telephone triage only, including video streaming triage, resulting in ambulance dispatch
Initial on-scene assessments performed by the ambulance crew
Patients initially considered for hospital conveyance based on clinical assessment
Disqualifiers
Non-emergency calls (e.g., interfacility transport or scheduled patient transport)
General practitioner-commissioned ambulance dispatches where the patient has been physically assessed by a general practitioner or another physician before ambulance arrival
Immediate need for emergency transport to hospital as determined by clinical assessment
Persistent unstable vital signs outside predefined operational thresholds, except for known chronic baseline deviations (e.g., reduced oxygen saturation in patients with chronic obstructive pulmonary disease or chronic tachyarrhythmia in atrial fibrillation)
Trial design
Design model
Parallel
Treatments tested in this trial
Point-of-care testing (POCT)
Diagnostic testOn-scene biochemical testing performed using portable point-of-care devices. non-conveyance.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: POCT-supported assessmentExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Implementation of prehospital POCT
Implementation of prehospital POCT, defined as the proportion of intervention-cluster attended patient encounters within the study population in which POCT was attempted, at least one valid POCT result was obtained and documented, and the result was available before the final conveyance decision.
Time frame
Day 1 (at completion of on-scene assessment)Secondary outcomes
1
Non-conveyance rate
Proportion of patients not conveyed to hospital following ambulance assessment during the index EMS encounter
Time frame
Day 1 (at completion of on-scene assessment)2
Proportion of non-conveyed participants with hospital admission within 24 hours
Proportion of participants with hospital admission within 24 hours among patients not conveyed at the index EMS encounter
Time frame
At 24 hours after the index EMS encounter3
Proportion of participants with short-stay hospitalization (<6 hours without advanced hospital-based interventions)
Proportion of participants with short-stay hospitalization lasting less than 6 hours without documented advanced procedures, medication administration, or CT/MR imaging during the admission
Time frame
At 6 hours after hospital admission4
Total hospital length of stay
Time from initial hospital admission to hospital discharge to home or to care facility.
Time frame
From hospital admission to hospital discharge (up to 30 days)Other outcomes
1
30-day hospital admission rate
30-day hospital admission rate, defined as any hospital admission occurring within 30 days after the index EMS encounter.
Time frame
At 30 days after the index EMS encounter2
Emergency department (ED) visit or hospital admission within 72 hours after non-conveyance
Emergency department (ED) visit or hospital admission within 72 hours after non-conveyance, defined as any ED encounter or hospital admission occurring within 72 hours of the index non-conveyance encounter, regardless of referral pathway (e.g.,out-of-hours primary care (OOH-PC), EMS, general practitioner, or self-referred).
Time frame
At 72 hours after the index non-conveyance encounter3
Out-of-hour primary care (OOH-PC) contact within 72 hours after non-conveyance
OOH-PC contact within 72 hours after non-conveyance, defined as any registered out-of-hours primary care contact within 72 hours of the index non-conveyance encounter.
Time frame
At 72 hours after the index non-conveyance encounter.4
EMS recontact within 72 hours after non-conveyance
EMS recontact within 72 hours after non-conveyance, defined as any new emergency call resulting in ambulance dispatch within 72 hours of the index non-conveyance encounter.
Time frame
At 72 hours after the index non-conveyance encounter.Sponsors and contacts
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Source ClinicalTrials.gov