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Mobile Transmission of Prehospital Vital Signs to the Emergency Department

Primary Purpose

Telemedicine, Triage, Emergency Medical Service

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB Sweden

About this trial

This is an interventional health services research trial for Telemedicine focused on measuring Telemedicine, Mobile, Vital signs, Prehospital care, Emergency medicine

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients transported with ambulance to the emergency department

Exclusion Criteria:

None

Sites / Locations

Prehospital Emergency Medical Services, Aarhus, Central Denmark Region
Horsens Regional Hospital, Central Region Denmark
Responce A/S

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transmission of vital signs, ecg, chat

No transmission of data

Arm Description

Data from patients transported in ambulances with equipment which enables real time transmission of vital signs, ecg and chat from ambulances to the emergency department.

Patient transported with conventional ambulances without the possibility to transmit real time patient related data.

Outcomes

Primary Outcome Measures

Time to physician

Time from the patient arrival registered in the patients' logistics system (Cetrea) to registered first patient/physician contact registered in the same patients logistics system.

Secondary Outcome Measures

All cause mortality

Time to treatment

Time from the patient arrival registered in the patients' logistics system (Cetrea) to first administered iv antibiotics registered in the patient's hospital record

Time to x-ray

Time from the patient arrival registered in the patients' logistics system (Cetrea) to completion of x-ray requisition form registered in the radiologic logistics system (Kodak RIS, 2010 edition)

Time to ICU

Time from the patient arrival registered in the patients' logistics system (Cetrea) to time of admission to the ICU registered in the patient's hospital record. .

Number of ICU admissions

Full Information

NCT ID

NCT02090452

First Posted

February 20, 2014

Last Updated

April 23, 2014

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital, Central Denmark Region

1. Study Identification

Unique Protocol Identification Number

NCT02090452

Brief Title

Mobile Transmission of Prehospital Vital Signs to the Emergency Department

Official Title

Telemedical Solutions in Medical Emergencies, Advantages and Disadvantages for Patients, Healthcare Professionals, and the Healthcare System: Study 1: "Mobile Transmission of Prehospital Vital Signs to the Emergency Department - Effect on Patient Outcomes, Treatment and Diagnosis"

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital, Central Denmark Region

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to examine if real time transmission of vital signs, ECG and chat communication between the prehospital ambulances and the emergency department has an effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to treatment and time to diagnostics

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Telemedicine, Triage, Emergency Medical Service

Keywords

Telemedicine, Mobile, Vital signs, Prehospital care, Emergency medicine

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transmission of vital signs, ecg, chat

Arm Type

Experimental

Arm Description

Data from patients transported in ambulances with equipment which enables real time transmission of vital signs, ecg and chat from ambulances to the emergency department.

Arm Title

No transmission of data

Arm Type

No Intervention

Arm Description

Patient transported with conventional ambulances without the possibility to transmit real time patient related data.

Intervention Type

Device

Intervention Name(s)

Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB Sweden

Other Intervention Name(s)

Vital signs, ECG and Chat-messaging delivered real time from prehospital ambulances to the receiving emergency dept.

Primary Outcome Measure Information:

Title

Time to physician

Description

Time from the patient arrival registered in the patients' logistics system (Cetrea) to registered first patient/physician contact registered in the same patients logistics system.

Time Frame

Time from arrival to first patient-physician contact, assessed up to 36 months

Secondary Outcome Measure Information:

Title

All cause mortality

Time Frame

30 days, assessed up to 36 months

Title

Time to treatment

Description

Time from the patient arrival registered in the patients' logistics system (Cetrea) to first administered iv antibiotics registered in the patient's hospital record

Time Frame

Time from arrival to administration of first iv. antibiotics, assessed up to 36 months

Title

Time to x-ray

Description

Time from the patient arrival registered in the patients' logistics system (Cetrea) to completion of x-ray requisition form registered in the radiologic logistics system (Kodak RIS, 2010 edition)

Time Frame

Time form arrival at the emergency department to completion of x-ray requisition form, assessed up to 36 months

Title

Time to ICU

Description

Time from the patient arrival registered in the patients' logistics system (Cetrea) to time of admission to the ICU registered in the patient's hospital record. .

Time Frame

Time from arrival to admission to the ICU, assessed up to 36 months

Title

Number of ICU admissions

Time Frame

During present hospitalization, assessed up to 36 months

Other Pre-specified Outcome Measures:

Title

Emergency department staff evaluation of usability of equipment

Description

The staff at the emergency department fill out a survey after the use of the equipment which provides ecg, vital signs, chat.

Time Frame

At the time of using the equipment, assessed up to 36 months

Title

Ambulance staff evaluation of usability of equipment

Description

The ambulance staff fill out a survey after the use of the equipment which provides ecg, vital signs, chat.

Time Frame

At the time of using the equipment, assessed up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients transported with ambulance to the emergency department Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erika F. Christensen, MD, Medical director

Organizational Affiliation

Central Denmark Region

Official's Role

Study Director

Facility Information:

Facility Name

Prehospital Emergency Medical Services, Aarhus, Central Denmark Region

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Horsens Regional Hospital, Central Region Denmark

City

Horsens

ZIP/Postal Code

8700

Country

Denmark

Facility Name

Responce A/S

City

Horsens

ZIP/Postal Code

8700

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Mobile Transmission of Prehospital Vital Signs to the Emergency Department

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