NCT07503470

The Pre-POCT-Non-Conveyance Trial: Prehospital Point-of-Care Testing to Support Non-Conveyance Decisions

Prehospital Point-of-Care Testing to Support Decision-Making in Alternative and Non-Conveyance Pathways: A Matched Parallel Cluster-Randomised Trial. The Pre-POCT-Non-Conveyance Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Central Denmark Region · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine whether rapid blood tests performed in the ambulance can help identify adults who can safely remain at home instead of being transported 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 transported. The main question is whether access to POCT increases the proportion of patients who remain at home rather than being transported to hospital. Safety outcomes will include hospital admission within 24 hours among non-conveyed patients, short-stay hospitalization (defined as admission \<6 hours without advanced interventions), intensive care unit (ICU) admission, and 30-day mortality. This study will evaluate whether POCT-supported decision-making can increase non-conveyance without compromising patient safety.

Detailed description

Many adults assessed by ambulance services are transported to hospital but discharged shortly after arrival without requiring advanced diagnostic testing or treatment. These potentially avoidable admissions contribute to emergency department crowding and increased healthcare utilization. Improving prehospital decision-making may reduce unnecessary hospital transports while maintaining patient safety. This study evaluates whether rapid point-of-care blood testing performed by ambulance clinicians can support more informed decisions regarding hospital conveyance following an emergency call. This is a prospective, matched, parallel, cluster-randomized trial conducted within the Prehospital Emergency Medical Services (EMS) of the Central Denmark Region, Denmark. Ten ambulance clusters are included and allocated in a 1:1 ratio to either an intervention strategy integrating point-of-care testing (POCT) into the prehospital assessment or to standard care. Prior to randomization, clusters are matched in pairs based on their historical non-conveyance rate during the preceding six months, overall case volume, and geographic characteristics to ensure balance in baseline practice patterns and workload and to reduce between-cluster heterogeneity. Each matched pair is then randomized to either the intervention or control group. Participants are adults attended by participating ambulance clusters following an emergency call resulting in ambulance dispatch. In the intervention clusters, POCT may be performed only after telemedical consultation with an Emergency Medical Dispatch Centre (EMDC) physician and only in patients who would otherwise be conveyed to hospital based on the initial on-scene ambulance assessment. The intervention consists of on-scene biochemical testing using portable POCT devices. The iSTAT Alinity system with CHEM8+ cartridges measures sodium, potassium, chloride, urea, creatinine, glucose, total carbon dioxide, hematocrit, and hemoglobin. QuickRead go® is used to measure C-reactive protein and hemoglobin, and HemoCue® WBC DIFF is used to measure leukocyte count. Control clusters follow existing assessment procedures without access to POCT. Apart from access to POCT devices and results, all other aspects of clinical management follow standard regional EMS practice. The primary objective is to evaluate whether access to POCT increases non-conveyance following on-scene assessment. Analyses will follow the intention-to-treat principle according to cluster allocation. Safety will be assessed using short-term clinical outcomes and indicators of adverse events. The trial is powered to detect an increase in non-conveyance from 20% to 30% (absolute increase of 10 percentage points). Ethics and regulatory oversight: The study has been assessed by the Central Denmark Region Committees on Health Research Ethics (Denmark) and determined not to constitute a health research study under Danish legislation (Consolidation Act on Research Ethics Review of Health Research Projects, Section 2(1)). Therefore, the study does not require approval from a research ethics committee, and formal ethics approval was not obtained. In accordance with this determination, individual informed consent is not required, as the study is conducted at the cluster level within routine care without alteration of standard treatment pathways beyond the availability of point-of-care testing. All data are handled in compliance with applicable data protection regulations. The determination is documented in a formal written statement from the Central Denmark Region Committees on Health Research Ethics. This documentation is included as an appendix to the Statistical Analysis Plan. No biological samples are stored for research purposes beyond immediate clinical analysis.

Conditions

• Prehospital Emergency Medical Services
• Prehospital Emergency Care
• Point of Care Testing

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Point-of-care testing (POCT)	On-scene biochemical testing performed using portable point-of-care devices. non-conveyance.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: Denmark