Pediatrics Clinical Trial
Official title:
Videos and Simple Text to Empower Parents to Handle Their Sick Children
NCT number | NCT04301206 |
Other study ID # | BB |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 28, 2020 |
Est. completion date | December 13, 2021 |
Verified date | July 2023 |
Source | Emergency Medical Services, Capital Region, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1558 |
Est. completion date | December 13, 2021 |
Est. primary completion date | December 13, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 143 Months |
Eligibility | Inclusion Criteria: - Parents calling 1813 with children aged 6 months to 11,9 years who accepts to receive the new information material. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Emergency Medical Services | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Emergency Medical Services, Capital Region, Denmark | Copenhagen University Hospital at Herlev, Copenhagen University Hospital Bispebjerg, Copenhagen University Hospital Nordsjælland, Copenhagen University Hospital, Hvidovre, Hospital of Bornholm, Denmark, Region Headquarters, Copenhagen (Regionsgården, Region Hovedstaden), Rigshospitalet, Denmark, TrygFonden, Denmark, University of Copenhagen |
Denmark,
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. — View Citation
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. — View Citation
Rasmussen, MV. Sektionen for data, controlling og IT, Akutberedskabet, Region Hovedstaden. January 2018 (data extract from the patient database at Emergency Services, Copenhagen)
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Use of professional consultations | Difference in the number of parents in the two arms who answered Yes to the question "Did a nurse/doctor examine your child during this period of sickness?" | Registered by questionnaire sent out at 12pm the day after the medical helpline contact | |
Secondary | Did the new material about sick children result in more satisfied parents? | Difference in the number of parents in the two arms who expressed a "very high degree" or "high degree" of satisfaction | Registered by questionnaire sent out at 12pm the day after the medical helpline contact | |
Secondary | Course of action at the medical helpline | Difference between the two arms in the percentage of children that are given health-information, performing video transmission for telephone triage, using the "call-back"- option , administrating any sort of treatment during the medical helpline-call, admission to hospital, ambulance, doctors ambulance | disposition is registered by the call operator immediately after the call | |
Secondary | Hospital visits | difference between the two arms in the percentage of how many children that are seen at a hospital within 8 hours hours, 12 hours, 24 hours, 48 hours, 48-72 hours after the call to medical helpline, and does that match the disposition registered by the medical professional at the medical helpline? Which diagnosis was given at the hospital? If admitted to the hospital, are there then any difference between the two arms in the percentage of how many children received treatment and paraclinical test? If admitted to the hospital, are there then any difference between the two arms in the percentage of the duration and type of admission? | the hospital chart of all children are read within 3-8 days after the call | |
Secondary | Non-participating parents | Description of differences in the ages, diagnoses, dispositions between the children whose parents wanted to participate in video triage and those who did not. | these parameters will be studied at the completion of enrollment of patients |
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