Videos and Simple Text to Empower Parents to Handle Their Sick Children

NCT04301206 | Completed DMC

• 1 other identifier: BB
• Study Type: interventional
• Target: 1,558
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The Medical Helpline 1813 (Capital Region, Denmark) handles acute, non-life-threatening medical emergencies. Approx. 200,000 calls/year concern children (ref: Rasmussen et al), and about 30% are referred to a pediatric urgent care center. However, many of these children presents very mild symptoms, which require neither treatment nor paraclinical tests, merely parental guidance. We want to empower the parents when handling their sick children by videos and simple text accessible from their smartphone. We want the parents to handle mild symptoms at home and to know when they must contact the medical helpline 1813 or a general practitioner. We have produced 8 short videos and simple texts about the most common symptoms in sick children. The material covers about 70% of the symptoms in acute sick children. The material is developed in collaboration between pediatricians and professional movie producers and is approved by the Danish Society of Pediatrics and other relevant medical societies. Purpose: It will be studied if the new material about symptoms in sick children result in 5% higher parental self-efficacy among the parents who were allowed to watch the material. Moreover, it will be studied if the new material resulted in less children examined by a doctor, and satisfied parents. Method: Parents who call the medical helpline about a medically ill child aged 6 months to 12 years will be offered to try the new material. If they accept, every second parent will be allowed given access to the new material, and every other parent will receive the usual triage by telephone. The results of these otherwise similar groups will be compared. Parents answer surveys about their experiences. Yield: Videos and simple text may empower parents to handle their sick children. The study may result in fewer children referred to hospitals, more appropriate use of resources and better experiences for the families.

Conditions

Pediatrics; Efficacy, Self; Triage

Keywords

education in medical conditions

Outcome Measures

Primary Outcomes (1)

• Changed in parental self-efficacy: Difference in the number of parents in the two arms suggesting that the new material about sick children resulted in an changed parental self-efficacy among the parents who were allowed to watch the material

  Difference in the number of parents in the two arms suggesting that the new material about sick children resulted in an changed parental self-efficacy among the parents who were allowed to watch the material. High parental self-efficacy defined as parents who answered "very much" or "to a great extent" to at least two of the following questions: "To which degree were you able to take care of your child, after contacting 1813?" "Do you know what to do at home, if your child presents the same symptoms another time?" "Do you know, the critical point at which you should contact your GP or 1813, if your child develops the same symptoms another time?"

  the parents are sent a link to an online questionnaire at 12pm the day after the medical helpline contact

Secondary Outcomes (5)

• Use of professional consultations

  Registered by questionnaire sent out at 12pm the day after the medical helpline contact

• Did the new material about sick children result in more satisfied parents?

  Registered by questionnaire sent out at 12pm the day after the medical helpline contact

• Course of action at the medical helpline

  disposition is registered by the call operator immediately after the call

• Hospital visits

  the hospital chart of all children are read within 3-8 days after the call

• Non-participating parents

  these parameters will be studied at the completion of enrollment of patients

Study Arms (2)

Intervention: Receiving video material

EXPERIMENTAL

The parents who accepts to participate and receives videos and action cards by sms

Behavioral: Intervention Group

Control group

NO INTERVENTION

The parents who accepts to participate, but proceed to 1813 and do not receive videos and action cards

Interventions

Intervention Group BEHAVIORAL

Empowerment of parents. When calling the medical helpline 1813 the parents will be offered to access the new material about sick children, compared to not getting this possibility.

Intervention: Receiving video material

Eligibility Criteria

• Age: 6 Months - 143 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents calling 1813 with children aged 6 months to 11,9 years who accepts to receive the new information material.

You may not qualify if:

• Children with parents who do not speak Danish
• Children without a Danish civil registration number
• The parent does not call from a Danish number
• Parents calling 1813 with children with an injury
• Parents calling 1813 within 72 hours regarding same child
• Parents who are not calling from a smart-phone

Sponsors & Collaborators

• Emergency Medical Services, Capital Region, Denmark: lead
• Copenhagen University Hospital, Hvidovre: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Rigshospitalet, Denmark: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Hospital of Bornholm, Denmark: collaborator
• University of Copenhagen: collaborator
• Copenhagen University Hospital Nordsjælland: collaborator
• TrygFonden, Denmark: collaborator
• Region Headquarters, Copenhagen (Regionsgården, Region Hovedstaden): collaborator

Study Sites (1)

Emergency Medical Services

Copenhagen, Denmark

Location

Related Publications (4)

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

  BACKGROUND

• Pehora C, Gajaria N, Stoute M, Fracassa S, Serebale-O'Sullivan R, Matava CT. Are Parents Getting it Right? A Survey of Parents' Internet Use for Children's Health Care Information. Interact J Med Res. 2015 Jun 22;4(2):e12. doi: 10.2196/ijmr.3790.

  PMID: 26099207 BACKGROUND

• Fahy E, Hardikar R, Fox A, Mackay S. Quality of patient health information on the Internet: reviewing a complex and evolving landscape. Australas Med J. 2014 Jan 31;7(1):24-8. doi: 10.4066/AMJ.2014.1900. eCollection 2014.

  PMID: 24567763 BACKGROUND

• Borch-Johnsen L, Gren C, Lund S, Folke F, Schroder M, Frederiksen MS, Lippert F, Ersboll AK, Greisen G, Cortes D. Video Tutorials to Empower Caregivers of Ill Children and Reduce Health Care Utilization: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2336836. doi: 10.1001/jamanetworkopen.2023.36836.

  PMID: 37824145 DERIVED

Study Officials

• Dina Cortes, MD, DrMedSci

  Department of Pediatrics, Copenhagen University Hospital Hvidovre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The parents of children aged 6 months to 11.9 years who calls 1813 about a medical condition will be offered to participate in the study. They will hear a recorded instruction, explaining the study. If they accept to participate they will be allocated to the intervention group and the control group 1:1.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 10, 2020
• Study Start: September 28, 2020
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)