NCT04074239

Brief Summary

Background: The Medical Helpline 1813 in Copenhagen, Denmark handles acute, non-life threatening medical emergencies. Approx. 200,000 calls/year concern children, and about 30% are referred to a pediatric urgent care center. However, most of these children have very mild symptoms, which require neither treatment nor tests, merely parental guidance. Initial assessment; triage, of children on the phone is difficult, especially when the operator does not know the child or family, and when it is difficult to describe the symptoms in medical terms. This may result in too many not-so-sick children and too few more severely sick children getting sent to hospital. Many parents are very worried about their sick child, but it is not known if this worry can be integrated in the triage process. Purpose: It will be studied if triage by video calls; video triage; provide greater security for parents and call operators so that more children can stay at home after medical guidance, causing at least 10% fewer visits to pediatric urgent care centers. The degree of worry of the parents will also be registered. Method: Children aged 3 months to 5 years with fever will be triaged by either video or telephone every other day, to compare the results between these to otherwise similar groups. Operators and parents answer surveys about their experiences. Yield: Video triage can "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
801

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

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

August 5, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

August 14, 2019

Last Update Submit

August 11, 2020

Conditions

Keywords

telemedicineTriageCall centersFeverPediatrics

Outcome Measures

Primary Outcomes (1)

  • Disposition

    Difference between the arms in the percentage of children that stays at home the first 8 hours after the call, i.e. referral to self-care or GP.

    Disposition is registered by the operator immediately after the call for all patients included, throughout the project period..

Secondary Outcomes (14)

  • Admittance

    The hospital chart of all children is read within 2-8 days after the call for all patients included, throughout the project period.

  • Hospital visits

    The hospital chart of all children is read within 2-8 days after the call for all patients included, throughout the project period..

  • Treatment

    The hospital chart of all children is read within 2-8 days after the call for all patients included, throughout the project period..

  • Operators: satisfaction

    The operators fill out a survey immediately after the call for all patients included, throughout the project period..

  • Operators: DOW

    The operators fill out a survey immediately after the call for all patients included, throughout the project period..

  • +9 more secondary outcomes

Study Arms (2)

Video triage

EXPERIMENTAL

The sick child will be triaged on video by the operator.

Other: Video triage

Telephone triage

NO INTERVENTION

The sick child will be triaged solely on telephone by the operator.

Interventions

The operator at the Medical Helpline will offer the parent who's calling regarding the sick child to assess the child on video, as compared to the routine way; on the telephone.

Video triage

Eligibility Criteria

Age3 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parents state that the child has fever.
  • 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 (26)

  • Rasmussen MV. Data, controlling and IT section, Copenhagen Emergency Services. January 2019.

    BACKGROUND
  • Boisen AS. Implementeringen af Enstrenget og Visiteret Akutsystem i Region Hovedstaden - en analyse af samspillet mellem organisatorisk forandring og brugeradfærd. Institut for Folkesundhedsvidenskab, Københavns Universitet; 2015

    BACKGROUND
  • Børns brug af regionale sundhedsydelser. Center for Sundhed - Enhed for Tværsektoriel Udvikling. Region Hovedstaden. 2017. https://www.regionh.dk/til-fagfolk/Sundhed/Tvaersektorielt-samarbejde/samarbejdspulje-og-forebyggelse/Documents/rapport-boerns-brug-regionale-sundhedsydelser.pdf

    BACKGROUND
  • Analyse af børns brug af sundhedsydelser. Center for Sundhed - Enhed for Tværsektoriel Udvikling. Region Hovedstaden. 2017. https://www.regionh.dk/til-fagfolk/Sundhed/Tvaersektorielt-samarbejde/samarbejdspulje-og-forebyggelse/Documents/analyse_af_boerns_brug_af_sundhedsydelser.pdf

    BACKGROUND
  • Nijman RG, Oostenbrink R, Dons EM, Bouwhuis CB, Moll HA. Parental fever attitude and management: influence of parental ethnicity and child's age. Pediatr Emerg Care. 2010 May;26(5):339-42. doi: 10.1097/PEC.0b013e3181db1dce.

    PMID: 20404784BACKGROUND
  • Kelly M, Sahm LJ, Shiely F, O'Sullivan R, McGillicuddy A, McCarthy S. Parental knowledge, attitudes and beliefs regarding fever in children: an interview study. BMC Public Health. 2016 Jul 11;16:540. doi: 10.1186/s12889-016-3224-5.

    PMID: 27401677BACKGROUND
  • Crocetti M, Moghbeli N, Serwint J. Fever phobia revisited: have parental misconceptions about fever changed in 20 years? Pediatrics. 2001 Jun;107(6):1241-6. doi: 10.1542/peds.107.6.1241.

    PMID: 11389237BACKGROUND
  • Parkinson GW, Gordon KE, Camfield CS, Fitzpatrick EA. Anxiety in parents of young febrile children in a pediatric emergency department: why is it elevated? Clin Pediatr (Phila). 1999 Apr;38(4):219-26. doi: 10.1177/000992289903800403.

    PMID: 10326177BACKGROUND
  • Lægehåndbogen. Feber hos børn. https://www.sundhed.dk/sundhedsfaglig/laegehaandbogen/paediatri/symptomer-og-tegn/feber-hos-boern/

    BACKGROUND
  • Pantell RH, Newman TB, Bernzweig J, Bergman DA, Takayama JI, Segal M, Finch SA, Wasserman RC. Management and outcomes of care of fever in early infancy. JAMA. 2004 Mar 10;291(10):1203-12. doi: 10.1001/jama.291.10.1203.

    PMID: 15010441BACKGROUND
  • Woll C, Neuman MI, Aronson PL. Management of the Febrile Young Infant: Update for the 21st Century. Pediatr Emerg Care. 2017 Nov;33(11):748-753. doi: 10.1097/PEC.0000000000001303.

    PMID: 29095773BACKGROUND
  • Van den Bruel A, Aertgeerts B, Bruyninckx R, Aerts M, Buntinx F. Signs and symptoms for diagnosis of serious infections in children: a prospective study in primary care. Br J Gen Pract. 2007 Jul;57(540):538-46.

    PMID: 17727746BACKGROUND
  • Verbakel JY, Van den Bruel A, Thompson M, Stevens R, Aertgeerts B, Oostenbrink R, Moll HA, Berger MY, Lakhanpaul M, Mant D, Buntinx F; European Research Network on Recognising Serious Infection (ERNIE). How well do clinical prediction rules perform in identifying serious infections in acutely ill children across an international network of ambulatory care datasets? BMC Med. 2013 Jan 15;11:10. doi: 10.1186/1741-7015-11-10.

    PMID: 23320738BACKGROUND
  • Van den Bruel A, Bartholomeeusen S, Aertgeerts B, Truyers C, Buntinx F. Serious infections in children: an incidence study in family practice. BMC Fam Pract. 2006 Mar 28;7:23. doi: 10.1186/1471-2296-7-23.

    PMID: 16569232BACKGROUND
  • Kool M, Elshout G, Moll HA, Koes BW, van der Wouden JC, Berger MY. Duration of fever and course of symptoms in young febrile children presenting with uncomplicated illness. J Am Board Fam Med. 2013 Jul-Aug;26(4):445-52. doi: 10.3122/jabfm.2013.04.120265.

    PMID: 23833160BACKGROUND
  • Gamst-Jensen H, Huibers L, Pedersen K, Christensen EF, Ersboll AK, Lippert FK, Egerod I. Self-rated worry in acute care telephone triage: a mixed-methods study. Br J Gen Pract. 2018 Mar;68(668):e197-e203. doi: 10.3399/bjgp18X695021. Epub 2018 Feb 12.

    PMID: 29440015BACKGROUND
  • Gamst-Jensen H. Patients' self-assessment of illness and injury in telephone triage using a novel degree-of-worry scale. Ph.D. dissertation. Faculty of Health and Medical Science, University of Copenhagen; 2018.

    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
  • Regioner på vej med ny app: Hver tredje konsultation kan ske online. Dagens Medicin. 2018. https://dagensmedicin.dk/danske-regioner-lancerer-ny-app-hver-tredje-konsultation-kan-ske-online/

    BACKGROUND
  • Videokonsultationer skal få praktiserende læger til Mors og til andre lægedækningstruede områder. Region Nordjylland. http://rn.dk/service/nyhedsliste-rn/nyhed?id=48723d23-88da-4759-a685-9c9336bc6093

    BACKGROUND
  • Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: a systematic review of reviews. Int J Med Inform. 2010 Nov;79(11):736-71. doi: 10.1016/j.ijmedinf.2010.08.006.

    PMID: 20884286BACKGROUND
  • 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
  • McCarthy PL, Sharpe MR, Spiesel SZ, Dolan TF, Forsyth BW, DeWitt TG, Fink HD, Baron MA, Cicchetti DV. Observation scales to identify serious illness in febrile children. Pediatrics. 1982 Nov;70(5):802-9. No abstract available.

    PMID: 7133831BACKGROUND
  • 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
  • Gren C, Hasselager AB, Linderoth G, Frederiksen MS, Folke F, Ersboll AK, Gamst-Jensen H, Cortes D. Video triage in calls concerning children with fever at an out-of-hours medical helpline: a prospective quality improvement study. Scand J Trauma Resusc Emerg Med. 2023 Aug 29;31(1):41. doi: 10.1186/s13049-023-01106-9.

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dina Cortes, M.D.

    Department of Pediatrics, Copenhagen University Hopsital 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 by video every other day they are at work, and by telephone the other days. The children will hence be randomized to either video or telephone depending on what day they are calling and which operator they are talking to.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 30, 2019

Study Start

August 5, 2019

Primary Completion

February 2, 2020

Study Completion

February 20, 2020

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations