NCT03840564

Brief Summary

"Main objective: to demonstrate that the implementation of an extended panel solution for the point of care analysis of biological parameters (point of care : POC) in an emergency department (ED) reduces the length of stay (LOS) of patients Secondary objectives: to demonstrate the feasibility of implementing an expanded panel of POC solutions in an ED and the reduction of emergency overcrowding in the POC group. To determine the medico-economic impact of the extended implementation of POC solutions (cost-efficiency and health-economic study), to collect the satisfaction of medical (emergency physicians, medical biologists) and paramedical personnel as well as the satisfaction of patients. Inclusion criteria: Any patient consulting in the emergency department during the study period Non-inclusion criteria: Patients attending the emergency departments as part of dressing or trauma follow-up consultations Main criteria of judgment: Time between administrative registration and the patient's discharge or hospitalization decision, compared between the control period and the intervention period (POC). Design: Prospective, monocentric, controlled, cluster- randomized per week. Duration of center preparation (technical preparation and training of laboratory staff): 4 weeks Duration of inclusion period: 18 weeks Duration of patient participation: 1 day Total trial duration time: 22 weeks"

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

May 29, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

May 29, 2018

Last Update Submit

February 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • length of stay (LOS) of patients consulting the ED

    length of stay (LOS) of patients consulting the ED For each patient the time frame of LOS is comprised between the admission schedule in the ED and the schedule of medical conclusion on the medical file of each patient consulting the emergency department

    1 Week

Secondary Outcomes (6)

  • Incidence and duration of technical adverse events encountered with the POC platform

    through study completion (18 weeks)

  • ED's crowding

    1 Week, i.e. the size of one cluster period of observation

  • The time to results in each period and by biological parameter

    1 Week, i.e. the size of one cluster period of observation

  • health-economic impact

    through study completion (18 Weeks)

  • satisfaction of patients

    the last two weeks of the study: one week in the intervention period (POC) and one week in the control period (usual care)

  • +1 more secondary outcomes

Study Arms (2)

Group point of care (POC)

All the analyzes will be done in delocalized

Other: Point of care (POC)

control group

the analyzes will be done at the central laboratory

Interventions

All the analyzes will be done in delocalized

Group point of care (POC)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient consulting in the emergency department

You may qualify if:

  • Any patient consulting in the emergency department during the study period

You may not qualify if:

  • Patients attending the emergency departments as part of dressing or trauma follow-up consultations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié Salpetriere hospital

Paris, 75013, France

Location

Related Publications (1)

  • Hausfater P, Hajage D, Bulsei J, Canavaggio P, Lafourcade A, Paquet AL, Arock M, Durand-Zaleski I, Riou B, Oueidat N. Impact of Point-of-care Testing on Length of Stay of Patients in the Emergency Department: A Cluster-randomized Controlled Study. Acad Emerg Med. 2020 Oct;27(10):974-983. doi: 10.1111/acem.14072. Epub 2020 Jul 27.

MeSH Terms

Conditions

Emergencies

Interventions

Point-of-Care Systems

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hospital Information SystemsHospital AdministrationHealth Facility AdministrationOrganization and AdministrationHealth Services AdministrationManagement Information SystemsPatient Care Management

Study Officials

  • HAUSFATER Pierre, Pr, MD, PhD

    Pitie salpetriere hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2018

First Posted

February 15, 2019

Study Start

June 11, 2018

Primary Completion

October 14, 2018

Study Completion

December 21, 2018

Last Updated

February 15, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations