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

NCT ID: NCT04301206

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2021-12-13

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.

Detailed Description

Background:

Each year there are approximately 200.000 calls regarding sick children younger than 12 years (injuries excluded) to the medical helpline 1813 in the Capital Region of Denmark (ref: Rasmussen et al). These children are not so ill that the parents call the emergency helpline 112, but the parents need to contact the health care system outside their general practitioners' opening hours. After contact with the parents, the medical helpline health professionals (primarily physicians or nurses) may either: 1) refer the child to a pediatric department, 2) refer child to assessment in a pediatric urgent care center, 3) guide the parents on how to perform self-care at home or 4) advice the child to the general practitioners next work day. About 40 % of the calls to 1813 regarding children are referred to a hospital. We estimate that 40 % of those presents mild symptoms, which often does not require treatment or paraclinical tests and many could have benefitted from being observed at home.

Purpose:

Reviews conducted in child health related areas, have indicated that quality of health information varies significantly and Internet searches may reveal information that is not evidence-based, or may even be inconsistent with international treatment recommendations (ref: Pehora et al, Fahy et al). Often health information will also focus on diagnosis, not symptoms, which makes it difficult for parents to navigate the health directions. The study objective is to investigate if it is possible by using videos and simple action cards about common symptoms in children - to empower parents and citizens to take better care of sick children with milder symptoms at home including to know when they must call for medical help. This project therefore aims to, by increasing parental knowledge, decrease the number of children admitted to the hospital with mild symptoms, and to decrease the number of children with late arrival to the hospital with symptoms on critical illness.

Method:

Eight videos have been produced, each lasting about 2-3 minutes, about the following common symptoms: 1) vomiting or diarrhea, 2) difficulties in breathing, 3) fever, 4) abdominal pain, 5) sore throat, 6) a red eye, 7) pain in the ears, and 8) exanthemas. The videos will be accompanied by text, action cards, and be accessible on a smartphone. The information is in Danish. The material has been developed in collaboration between pediatricians (medical content) and professional film/app-makers (creative content) and has been approved by the Danish Society of Pediatrics and other relevant scientific societies. We want to study the clinical value of this material before we launch the campaign to the public.

Parents with children aged between 6 months - 11.9 years will, when contacting the medical helpline 1813, be offered to receive a new information material. If they accept, they will be randomized to the intervention group (randomized to the new material composed of 8 videos and corresponding smart cards) or to the control group (randomized to current standard care). The participants will the following day receive a text message with six questions on self-efficacy and satisfaction. If the caretaker does not fill out the electronical questionnaire, they will receive a reminder the next day. All case reports of the included children will be reviewed and if admitted to a hospital in the Capital Region of Denmark within 72 hours of the call, the diagnosis, duration and treatment will be registered. For the intervention group, the use of the material will be logged.

Statistics:

The primary analysis will use Chi-square and a two-sided level of significance of p < 0.05 for the primary outcome and a p<0.025 for the two secondary outcomes. All other outcomes are exploratory and the statistical methods will be adapted as appropriate. The results from these exploratory analyses will not but used to claim clinical efficacy but used to design new studies. This is an important aspect since new studies can be rapidly designed and performed once the project set-up is in place.

Sample size:

We want to be able to detect if the intervention with videos and action cards increases the proportions of parents who expressed high self-efficacy by 5%. We do not know this actual proportion. If it is actually 50%, we want to detect an increase to 55%. We want a p-value of 0.05 and a probability (power) of 80%. It will require data from about 3300 text-messages in total, randomized in two equal groups (http://www.openepi.com/SampleSize/SSCohort.htm). We suggest we have data to answer our research question within 3 months, and the study will be stopped after 6 months.

After the first 400 SMS-answers, we will perform an interim analysis to study the frequency of acceptance, and the frequency of high self-efficacy, as well as how the videos have worked technically. Moreover, we will study if the number of SMS-answers from the two groups of families, those randomized to intervention and those randomized to control, are about the same size.

After the first 1000 SMS-answers, we will also make an interim analysis to study the effect of the videos and the action cards. This will also include an examination of a significant difference is exhibited between the number of children staying at home the day the parents call 1813 after having the possibility to watch the videos and read the action cards.

Ethics and transparency:

The parents are informed about the study by an automatic voice message when contacting the medical helpline 1813. Their acceptance to the study is their informed consent. The project will be described in short at the webpage of the Copenhagen Emergency Service, where it will be possible to access additional information via a link to the study at Clinical Trials. The telephone call will be recorded in the Emergency Medical Services system, based on the actual regular routine. The protocol has been submitted to the Ethics Committee of the Capital Region of Denmark, who considered it outside their mandate.

In the project the data will be completely anonymized and it is in no way possible to link data with actual people. The study will be registered at https://clinicaltrials.gov/ before enrolment of the first patient.

In cases of serious adverse events the study group will consider stopping the study. This will also be the case if the satisfaction with the contact to the medical helpline 1813 drops to a very low level.

Perspectives and possible yield:

In case of positive effect, it must be decided if the videos and action cards will be an integrated option at the medical helpline 1813. Moreover, it may be considered if the material is released to all of Denmark. The material could be accessible at smartphones, iPads, laptops and easy to find on different major national websites.

Conditions

Pediatrics; Efficacy, Self; Triage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Intervention: Receiving video material

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

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention Group

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 Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 143 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital Bispebjerg

UNKNOWN

Sponsor Role: collaborator

Hospital of Bornholm, Denmark

UNKNOWN

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital Nordsjælland

UNKNOWN

Sponsor Role: collaborator

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

Region Headquarters, Copenhagen (Regionsgården, Region Hovedstaden)

UNKNOWN

Sponsor Role: collaborator

Emergency Medical Services, Capital Region, Denmark

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dina Cortes, MD, DrMedSci

Role: STUDY_CHAIR

Department of Pediatrics, Copenhagen University Hospital Hvidovre

Locations

Emergency Medical Services

Copenhagen, , Denmark

Countries

Denmark

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26099207 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24567763 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37824145 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BB

Identifier Type: -

Identifier Source: org_study_id