NCT03874520

Brief Summary

Background The medical helpline 1813 in Copenhagen, Denmark handles telephone calls regarding non-life-threatening medical emergencies. Next to 200,000 calls/year concern children and afterwards about 30% are referred to a pediatric urgent care center. However, most of these children have very mild symptoms, which do neither require treatment nor any tests, but merely parental medical guidance. Initial assessment; triage, of children on the telephone is difficult, especially when the operator does not know the child or the parents, and when it is difficult to describe the symptoms in medical terms. This may result in both too many not-so-sick children getting unnecessarily referred to hospitals, and perhaps also too few more severely sick children sent to the hospital. Purpose This project will study if triage of children by videocalls (video triage) provide greater security for parents and health care personnel in the decision that more children can stay at home after medical guidance, thus causing at least 10% fewer visits to a pediatric urgent care center. Furthermore, the investigators will study if video triage identifies more children with the need of urgent admission to a Department of Pediatrics. Method Children aged 6 months to 5 years with symptoms from the respiratory tract will be triaged by either video or telephone by an operator every other day, in order to compare the results between these two similar groups. In cases of video triage, the parent will receive a text message to their smartphone with a video link. The safety of video triage will be assessed by reviewing the hospital case reports of all patients for contact within the 48 hours after the 1813 call. Perspectives Video assessment at call centers may "give eyes to the operators" and revolutionize telephone triage. The study may result in fewer children referred to hospitals, more appropriate use of resources and better experiences for the families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
734

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

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

February 25, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

March 11, 2019

Last Update Submit

July 27, 2020

Conditions

Keywords

TelemedicineTriageCall CentersRespiratory Tract DiseasesPediatrics

Outcome Measures

Primary Outcomes (1)

  • Disposition

    difference between the two arms in the percentage of children that can stay at home the day the parents call 1813, i.e. referral to self-care or GP, compared to the control group.

    disposition is registered by the call operator immediately after the call.

Secondary Outcomes (14)

  • Admission

    disposition is registered by the call operator immediately after the call.

  • Hospital visits

    the hospital chart of all children are read within 2-8 days after the call.

  • Safety of disposition choice: percentage of duration of admission

    the hospital charts of all children are read within 2-8 days after the call.

  • Nurses' satisfaction: percentage of nurses that were satisfied

    the nurses fill out a questionnaire about the call immediately after each call.

  • Technical difficulty, nurses

    the nurses fill out a questionnaire about the call immediately after each call.

  • +9 more secondary outcomes

Study Arms (2)

Video triage

EXPERIMENTAL

The sick child will be assessed on video by the operator at the call-center.

Other: Video triage

Telephone triage

NO INTERVENTION

The sick child will be assessed solely over the telephone by the operator at the call-center.

Interventions

The operator will offer the parent calling regarding the sick child to assess the child on video, as compared to the current standard; on the telephone.

Video triage

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Symptoms presented to the 1813 operator categorized as: coughing/breathing difficulties, cold or suspected influenza.
  • Parents are calling from a smartphone with Apple, Windows or Android operating system.

You may not qualify if:

  • The child has already participated.
  • The parent does not call from a Danish telephone number.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Medical Services

Copenhagen, Denmark

Location

Related Publications (7)

  • Rasmussen, MV. Sektionen for data, controlling og IT, Akutberedskabet, Region Hovedstaden. January 2018 (data extract from the patient database at Emergency Services, Copenhagen)

    BACKGROUND
  • Olson CA, Thomas JF. Telehealth: No Longer an Idea for the Future. Adv Pediatr. 2017 Aug;64(1):347-370. doi: 10.1016/j.yapd.2017.03.009. No abstract available.

    PMID: 28688597BACKGROUND
  • COMMITTEE ON PEDIATRIC WORKFORCE; Marcin JP, Rimsza ME, Moskowitz WB. The Use of Telemedicine to Address Access and Physician Workforce Shortages. Pediatrics. 2015 Jul;136(1):202-9. doi: 10.1542/peds.2015-1253.

    PMID: 26122802BACKGROUND
  • Siew L, Hsiao A, McCarthy P, Agarwal A, Lee E, Chen L. Reliability of Telemedicine in the Assessment of Seriously Ill Children. Pediatrics. 2016 Mar;137(3):e20150712. doi: 10.1542/peds.2015-0712. Epub 2016 Feb 5.

    PMID: 26908666BACKGROUND
  • Gattu R, Scollan J, DeSouza A, Devereaux D, Weaver H, Agthe AG. Telemedicine: A Reliable Tool to Assess the Severity of Respiratory Distress in Children. Hosp Pediatr. 2016 Aug;6(8):476-82. doi: 10.1542/hpeds.2015-0272.

    PMID: 27450148BACKGROUND
  • Freeman B, Mayne S, Localio AR, Luberti A, Zorc JJ, Fiks AG. Using Video from Mobile Phones to Improve Pediatric Phone Triage in an Underserved Population. Telemed J E Health. 2017 Feb;23(2):130-136. doi: 10.1089/tmj.2016.0082. Epub 2016 Jun 21.

    PMID: 27328326BACKGROUND
  • Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.

    PMID: 25662947BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Diseases

Study Officials

  • Dina Cortes, MD, DrMedSci

    Department of Pediatrics, Copenhagen University Hospital Hvidovre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The operators at the medical helpline 1813 will triage children meeting the inclusion criteria using video every other day they are at work, and over telephone the other days. Consequently, the operators are always the same, and the only difference between the two groups of patients will be if video triage or telephone triage is performed.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 14, 2019

Study Start

February 25, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations