TelemedicineNCT03874520
Using Video Transmission for Telephone Triage of Children
A study testing Video triage in people with Telemedicine and Triage, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Telemedicine, Triage, Respiratory Tract Diseases
- What is being tested?
- Video triage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 734 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Feb 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- The child has already participated.
- The parent does not call from a Danish telephone number.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Video Transmission for Optimized Telephone Triage of Children With Respiratory Symptoms at the Medical Helpline 1813 in Copenhagen, Denmark
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.
Read more
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.
Read the detailed description
Background
Each year the Copenhagen Emergency Services receives approximately 190,000 calls to the medical helpline 1813 regarding sick children younger than 12 years (injuries excluded) (Rasmussen MV, ref. 1). These children are not so sick that the parents call the emergency helpline 112, but the parents need to contact the health care system outside their general practitioners' (GP) opening hours.
After contact with the parents the medical helpline 1813's health professionals have several possibilities for the children; e.g. admitting the children to a Department of Pediatrics, referring them to assessment in Børnelægevagten (a pediatric urgent care center), guiding them to self-care at home, or referring them to their GP the next workday.
Of the 190,000 calls annually regarding sick children, the majority of the calls concerns small children; in 2018, about 175,000 of the calls concerned children younger than 6 years. About 30% of these children were referred to assessment in a pediatric urgent care center. Most of these patients have mild symptoms which do neither require treatment nor paraclinical testing, but merely parental medical guidance. These consultations can be experienced as unnecessary and inappropriate for the sick child and its parents. Moreover, the visits are expensive for the health system.
Telephone triage is difficult, especially when the operator does not know the child or the parents, and when it is difficult to describe symptoms in medical terms. Telemedicine, i.e. the use of communication- and information technology within the healthcare system, is gaining increasing influence in the medical society, also within pediatrics (Olson CA et al, ref. 2). The American Academy of Pediatrics has urged both general pediatricians and pediatric subspecialists to use telemedicine to serve more children (Marcin JP et al, ref. 3).
Two studies both found good agreement between face-to-face and video-assisted assessment of children with respiratory symptoms (Siew L et al, Gattu R et al, ref. 4, 5). Another study about children with acute worsening of asthma, reported that the parents felt safer when the triage of the child was done by a health professional who could watch the child on video, and the health professionals also felt safer with the video triage (Freeman B et al, ref. 6).
Purpose
Does 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 Børnelægevagten (a pediatric urgent care center)? Furthermore, doses triage of children by videocalls (video triage) identify more children with the need of urgent admission to a Department of Pediatrics?
The project will investigate the safety of video triage, by subsequently reading in the children's hospital case reports and study if the children have been examined at a pediatric department within the first 48 hours after the 1813 call.
The investigators will also examine the parents' and the operators' experience with the video call, regarding feelings of safety and the technical quality.
The project thus aims to evaluate the value of improving triage with the new technology, video calls.
To our knowledge, there are no other studies of the effect of video calls in the initial triage of children.
Methods
Study design and structure:
The project is a prospective quality improvement study investigating the results of a new intervention.
Initially, a smaller group of nurses is trained in video triage. They will offer video triage every other work day, i.e. one-day video triage and the next day ordinary telephone triage, etc. Consequently, the operators are always the same, and the only difference between the groups will be if video triage is performed.
During the project period, more nurses will be trained in video triage. There will thus be a step-by-step inclusion of nurses who carry out video triage. The project thereby has the character of a stepped wedge randomized trial (Hemming K et al, ref. 7).
The results from video triage days will be compared with results from non-video triage days. The control group will thus be the patients from non-video triage days.
Method of video triage:
Initially 20 operators, all nurses, will be trained in video triage. During the project period, on video days, the operators will offer video triage to children aged 6 months up to and including 5 years, with respiratory symptoms.
The parents will receive a text message with a link on their smartphone, which upon activation starts a video call with the operator at 1813.
The operators will use the medical history as well as the video, i.e. both video and audio, to make a plan for the child together with the parent.
Immediately after the call, the parents will receive a text message with a link to an electronic questionnaire regarding their experience with the call and the assessment of their child.
After the call, the operators at 1813 will also answer an electronic questionnaire, about the experience regarding the call.
On non-video days, the operators will enroll corresponding children to telephone triage. Similarly, these children's parents will receive a text message about their experience with the call, and the nurses will also fill out a questionnaire after these calls.
Within 2 to 8 workdays after the call the project group will read the child's hospital case report, to investigate if the child has been at a hospital within 8 hours or 48 hours after the call to 1813. If the child has been at a hospital, there will be noted for example date, time and diagnosis, and if the child was admitted to an intensive care unit, or in the worst case, got lasting injuries or died.
The data department at the Copenhagen Emergency Services will daily extract data on the children enrolled in the project from a patient treatment database at the Copenhagen Emergency Services, which was established with the approval of the regional information security department. The data sheet will include data on the patient and the call.
Sample size:
In 2018 there were 177,000 calls regarding children up to and including 5 years. Of the 177,000 calls, 9% were referred directly to admission at a department of Pediatrics, 30% were referred to assessment at pediatric urgent care center, 31% were guided in self-care, 25% were advised to call their GPs the next workday and 5% were referred to other options. That is, 56% stayed at home the day the parents called 1813.
The investigators hypothesize that video triage can result in at least 10% more parents staying at home with the child on the day they call 1813, i.e. an increase from 56% to 66%. With a power of 80% and two-sided significance of 95%, a total of 774 children distributed on two equal sized groups of 387 patients should be included according to openepi (http://openepi.com/SampleSize/SSCohort.htm).
If, on the other hand, video triage results in 15% more parents staying at home with the child the day they call 1813, i.e. an increase from 56% to 71%, it is only necessary to include 346 children in total to identify such a difference.
In contrast, if video triage results in 7% more parents staying at home with the child at the day, they call 1813, i.e. an increase from 56% to 63% 1582 children divided into two groups must be included, and if video triage only results in 5% more parents staying at home with the child at the day of the call to 1813, i.e. an increase from 56% to 61% 3102 children divided into two groups must be included. In all cases in according to openepi (http://openepi.com/SampleSize/SSCohort.htm) with a power of 80% and two-sided significance of 95%.
Statistics:
Non-parametric statistics, two-sided and with significance at p-value <0.05.
Interim analyses:
After the first 200 video calls, an interim analysis to study the effect of the video triage will be performed, including the period of time it has taken to enroll these children, as well as how the video triage technically has worked, in order to be able to correct possible problems. The safety will also be reviewed, in order to make sure that the children assessed on video do not have higher admittance rate and/or mortality rate, as a sign that they arrive too late to the hospital.
After the first 400 first calls, another interim analysis to study the effect of video calls will be made. This will also include a study of whether there is a significant difference between the number of children staying at home the day the parents call 1813 using video triage and using common telephone triage.
If no significant difference is revealed the study will go on and the effect of video triage will be evaluated when 774 patients has been enrolled.
If a significant effect is still not revealed between the patients using video triage and using common telephone triage the project will go on until 1600 patients have been included.
If no significant difference is revealed the study will go on and the effect of video triage will be evaluated when 3500 patients has been enrolled. However, the study will not go on more than 6 months.
Perspectives and possible yield
At the end of this initial project, the project group expect to know if use of video triage can increase the number of children who safely can stay at home the day their parents call 1813, i.e. the children are referred to self-care or to their GP. This may be beneficial for the sick child and its parents and there may be a socio-economic win. It will also be known if children with more severe symptoms more often are referred directly to a Department of Pediatrics, rather than to an initial assessment in a pediatric urgent care center.
After the study of the video triage, the management at the Emergency Services Copenhagen can decide if video triage will be an integrated option at the medical helpline 1813.
- Conditions
- Telemedicine, Triage, Respiratory Tract Diseases, Pediatrics
- Being tested
- Video triage
- Keywords
- Telemedicine, Triage, Call Centers, Respiratory Tract Diseases, Pediatrics
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video triageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Video triage | Experimental | The sick child will be assessed on video by the operator at the call-center. Receives: Other: Video triage |
| Telephone triage | No intervention | The sick child will be assessed solely over the telephone by the operator at the call-center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: disposition is registered by the call operator immediately after the call.
Secondary outcomes (14)
Admission
difference between the two arms in the percentage of children that are referred to admission at a Department of Pediatrics.
Measured: disposition is registered by the call operator immediately after the call.
Hospital visits
difference between the two arms in the percentage of how many children that are seen at a hospital within 8 hours or 48 hours after the call to 1813, and does that match the disposition registered by the 1813 nurse? Which diagnosis was given at the hospital?
Measured: the hospital chart of all children are read within 2-8 days after the call.
Safety of disposition choice: percentage of duration of admission
difference between the two arms in the percentage of duration of admission, admission to ICU and mortality.
Measured: the hospital charts of all children are read within 2-8 days after the call.
Nurses' satisfaction: percentage of nurses that were satisfied
difference between the two arms in the percentage of nurses that were satisfied with the call to a acceptable extent or better in the two groups.
Measured: the nurses fill out a questionnaire about the call immediately after each call.
Technical difficulty, nurses
the number of nurses that found the video call to be technically easy to conduct to a moderate extent or better.
Measured: the nurses fill out a questionnaire about the call immediately after each call.
Technical quality of the video call
the number of nurses that found the sound- and picture quality of the video call as acceptable or better.
Measured: the nurses fill out a questionnaire about the call immediately after each call.
Disposition choice
the percentage of nurses that felt safer about the choice of disposition after video triage compared to after a regular telephone triage, to a acceptable extent or better.
Measured: the nurses fill out a questionnaire about the call immediately after each call.
Parents' perception of getting answers to their questions
difference between the two arms in the percentage of parents that felt that they got their questions answered during the call to a acceptable extent or better.
Measured: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Parents' satisfaction about assessment: percentage of parents that felt safe about the assessment
difference between the two arms in the percentage of parents that felt safe about the assessment of their children to a acceptable extent or better.
Measured: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Parents' satisfaction about the plan for the child: percentage of parents that felt safe
difference between the two arms in the percentage of parents that felt safe about the plan for their children to a acceptable extent or better
Measured: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Parents' satisfaction about the call: number of parents in the two arms who were satisfied
difference in the number of parents in the two arms who were satisfied with the call to a acceptable extent or better.
Measured: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Technical difficulty, parents
the number of parents that found the video call to be technically easy to conduct to a acceptable extent or better.
Measured: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Economy
how many visits at the pediatric urgent care clinics and at departments of pediatrics, respectively, that could be avoided by using video triage.
Measured: the number of visits to hospitals in each arm will be studied at the completion of enrolling patients.
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.
Measured: these parameters will be studied at the completion of enrollment of patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start25 Feb 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 734 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Services, Capital Region, Denmark
- Sponsor type
- Other government
- Collaborators
- Copenhagen University Hospital, Hvidovre, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Rigshospitalet, Nordsjaellands Hospital, Copenhagen Academy for Medical Education and Simulation, University of Copenhagen, TrygFonden, Denmark, Amager-Hvidovre Hospital Research Foundation
- Responsible party
- Principal investigator, Caroline Gren, Emergency Medical Services, Capital Region, Denmark
- Investigators
- Dina Cortes, MD, DrMedSci, Study chair, Department of Pediatrics, Copenhagen University Hospital Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874520
- Sponsor's protocol ID
- Videotriage 1813
- Status last verified
- Jul 2020
- First submitted
- 11 Mar 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rasmussen, MV. Sektionen for data, controlling og IT, Akutberedskabet, Region Hovedstaden. January 2018 (data extract from the patient database at Emergency Services, Copenhagen)
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.
PubMed 28688597COMMITTEE 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.
PubMed 26122802Siew 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.
PubMed 26908666Gattu 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.
PubMed 27450148Freeman 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.
PubMed 27328326Hemming 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.
PubMed 25662947
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Video Transmission for Optimized Telephone Triage of Children With Respiratory Symptoms at the Medical Helpline 1813 in Copenhagen, Denmark
- ClinicalTrials.gov ID
- NCT03874520
- Acronym / sponsor ID
- Videotriage 1813
- Conditions
- Telemedicine, Triage, Respiratory Tract Diseases, Pediatrics
- Keywords
- Telemedicine, Triage, Call Centers, Respiratory Tract Diseases, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 734 participants (actual)
- Lead sponsor
- Emergency Medical Services, Capital Region, DenmarkOther government
- Collaborators
- Copenhagen University Hospital, Hvidovre, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Rigshospitalet, Nordsjaellands Hospital, Copenhagen Academy for Medical Education and Simulation, University of Copenhagen, TrygFonden, Denmark, Amager-Hvidovre Hospital Research Foundation
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Each year the Copenhagen Emergency Services receives approximately 190,000 calls to the medical helpline 1813 regarding sick children younger than 12 years (injuries excluded) (Rasmussen MV, ref. 1). These children are not so sick that the parents call the emergency helpline 112, but the parents need to contact the health care system outside their general practitioners' (GP) opening hours.
After contact with the parents the medical helpline 1813's health professionals have several possibilities for the children; e.g. admitting the children to a Department of Pediatrics, referring them to assessment in Børnelægevagten (a pediatric urgent care center), guiding them to self-care at home, or referring them to their GP the next workday.
Of the 190,000 calls annually regarding sick children, the majority of the calls concerns small children; in 2018, about 175,000 of the calls concerned children younger than 6 years. About 30% of these children were referred to assessment in a pediatric urgent care center. Most of these patients have mild symptoms which do neither require treatment nor paraclinical testing, but merely parental medical guidance. These consultations can be experienced as unnecessary and inappropriate for the sick child and its parents. Moreover, the visits are expensive for the health system.
Telephone triage is difficult, especially when the operator does not know the child or the parents, and when it is difficult to describe symptoms in medical terms. Telemedicine, i.e. the use of communication- and information technology within the healthcare system, is gaining increasing influence in the medical society, also within pediatrics (Olson CA et al, ref. 2). The American Academy of Pediatrics has urged both general pediatricians and pediatric subspecialists to use telemedicine to serve more children (Marcin JP et al, ref. 3).
Two studies both found good agreement between face-to-face and video-assisted assessment of children with respiratory symptoms (Siew L et al, Gattu R et al, ref. 4, 5). Another study about children with acute worsening of asthma, reported that the parents felt safer when the triage of the child was done by a health professional who could watch the child on video, and the health professionals also felt safer with the video triage (Freeman B et al, ref. 6).
Purpose
Does 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 Børnelægevagten (a pediatric urgent care center)? Furthermore, doses triage of children by videocalls (video triage) identify more children with the need of urgent admission to a Department of Pediatrics?
The project will investigate the safety of video triage, by subsequently reading in the children's hospital case reports and study if the children have been examined at a pediatric department within the first 48 hours after the 1813 call.
The investigators will also examine the parents' and the operators' experience with the video call, regarding feelings of safety and the technical quality.
The project thus aims to evaluate the value of improving triage with the new technology, video calls.
To our knowledge, there are no other studies of the effect of video calls in the initial triage of children.
Methods
Study design and structure:
The project is a prospective quality improvement study investigating the results of a new intervention.
Initially, a smaller group of nurses is trained in video triage. They will offer video triage every other work day, i.e. one-day video triage and the next day ordinary telephone triage, etc. Consequently, the operators are always the same, and the only difference between the groups will be if video triage is performed.
During the project period, more nurses will be trained in video triage. There will thus be a step-by-step inclusion of nurses who carry out video triage. The project thereby has the character of a stepped wedge randomized trial (Hemming K et al, ref. 7).
The results from video triage days will be compared with results from non-video triage days. The control group will thus be the patients from non-video triage days.
Method of video triage:
Initially 20 operators, all nurses, will be trained in video triage. During the project period, on video days, the operators will offer video triage to children aged 6 months up to and including 5 years, with respiratory symptoms.
The parents will receive a text message with a link on their smartphone, which upon activation starts a video call with the operator at 1813.
The operators will use the medical history as well as the video, i.e. both video and audio, to make a plan for the child together with the parent.
Immediately after the call, the parents will receive a text message with a link to an electronic questionnaire regarding their experience with the call and the assessment of their child.
After the call, the operators at 1813 will also answer an electronic questionnaire, about the experience regarding the call.
On non-video days, the operators will enroll corresponding children to telephone triage. Similarly, these children's parents will receive a text message about their experience with the call, and the nurses will also fill out a questionnaire after these calls.
Within 2 to 8 workdays after the call the project group will read the child's hospital case report, to investigate if the child has been at a hospital within 8 hours or 48 hours after the call to 1813. If the child has been at a hospital, there will be noted for example date, time and diagnosis, and if the child was admitted to an intensive care unit, or in the worst case, got lasting injuries or died.
The data department at the Copenhagen Emergency Services will daily extract data on the children enrolled in the project from a patient treatment database at the Copenhagen Emergency Services, which was established with the approval of the regional information security department. The data sheet will include data on the patient and the call.
Sample size:
In 2018 there were 177,000 calls regarding children up to and including 5 years. Of the 177,000 calls, 9% were referred directly to admission at a department of Pediatrics, 30% were referred to assessment at pediatric urgent care center, 31% were guided in self-care, 25% were advised to call their GPs the next workday and 5% were referred to other options. That is, 56% stayed at home the day the parents called 1813.
The investigators hypothesize that video triage can result in at least 10% more parents staying at home with the child on the day they call 1813, i.e. an increase from 56% to 66%. With a power of 80% and two-sided significance of 95%, a total of 774 children distributed on two equal sized groups of 387 patients should be included according to openepi (http://openepi.com/SampleSize/SSCohort.htm).
If, on the other hand, video triage results in 15% more parents staying at home with the child the day they call 1813, i.e. an increase from 56% to 71%, it is only necessary to include 346 children in total to identify such a difference.
In contrast, if video triage results in 7% more parents staying at home with the child at the day, they call 1813, i.e. an increase from 56% to 63% 1582 children divided into two groups must be included, and if video triage only results in 5% more parents staying at home with the child at the day of the call to 1813, i.e. an increase from 56% to 61% 3102 children divided into two groups must be included. In all cases in according to openepi (http://openepi.com/SampleSize/SSCohort.htm) with a power of 80% and two-sided significance of 95%.
Statistics:
Non-parametric statistics, two-sided and with significance at p-value <0.05.
Interim analyses:
After the first 200 video calls, an interim analysis to study the effect of the video triage will be performed, including the period of time it has taken to enroll these children, as well as how the video triage technically has worked, in order to be able to correct possible problems. The safety will also be reviewed, in order to make sure that the children assessed on video do not have higher admittance rate and/or mortality rate, as a sign that they arrive too late to the hospital.
After the first 400 first calls, another interim analysis to study the effect of video calls will be made. This will also include a study of whether there is a significant difference between the number of children staying at home the day the parents call 1813 using video triage and using common telephone triage.
If no significant difference is revealed the study will go on and the effect of video triage will be evaluated when 774 patients has been enrolled.
If a significant effect is still not revealed between the patients using video triage and using common telephone triage the project will go on until 1600 patients have been included.
If no significant difference is revealed the study will go on and the effect of video triage will be evaluated when 3500 patients has been enrolled. However, the study will not go on more than 6 months.
Perspectives and possible yield
At the end of this initial project, the project group expect to know if use of video triage can increase the number of children who safely can stay at home the day their parents call 1813, i.e. the children are referred to self-care or to their GP. This may be beneficial for the sick child and its parents and there may be a socio-economic win. It will also be known if children with more severe symptoms more often are referred directly to a Department of Pediatrics, rather than to an initial assessment in a pediatric urgent care center.
After the study of the video triage, the management at the Emergency Services Copenhagen can decide if video triage will be an integrated option at the medical helpline 1813.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video triage | Experimental | Other: Video triageThe sick child will be assessed on video by the operator at the call-center. |
| Telephone triage | No intervention | –The sick child will be assessed solely over the telephone by the operator at the call-center. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- The child has already participated.
- The parent does not call from a Danish telephone number.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video triageThe 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. | Other | Video triage |
Primary outcome
Disposition
Time frame: disposition is registered by the call operator immediately after the call.
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.
14 secondary outcomes
Admission
Time frame: disposition is registered by the call operator immediately after the call.
Hospital visits
Time frame: the hospital chart of all children are read within 2-8 days after the call.
Safety of disposition choice: percentage of duration of admission
Time frame: the hospital charts of all children are read within 2-8 days after the call.
Nurses' satisfaction: percentage of nurses that were satisfied
Time frame: the nurses fill out a questionnaire about the call immediately after each call.
Technical difficulty, nurses
Time frame: the nurses fill out a questionnaire about the call immediately after each call.
Technical quality of the video call
Time frame: the nurses fill out a questionnaire about the call immediately after each call.
Disposition choice
Time frame: the nurses fill out a questionnaire about the call immediately after each call.
Parents' perception of getting answers to their questions
Time frame: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Parents' satisfaction about assessment: percentage of parents that felt safe about the assessment
Time frame: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Parents' satisfaction about the plan for the child: percentage of parents that felt safe
Time frame: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Parents' satisfaction about the call: number of parents in the two arms who were satisfied
Time frame: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Technical difficulty, parents
Time frame: the parents are sent a link to an online questionnaire immediately after the call to 1813.
Economy
Time frame: the number of visits to hospitals in each arm will be studied at the completion of enrolling patients.
Non-participating parents
Time frame: these parameters will be studied at the completion of enrollment of patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- BackgroundRasmussen, MV. Sektionen for data, controlling og IT, Akutberedskabet, Region Hovedstaden. January 2018 (data extract from the patient database at Emergency Services, Copenhagen)
- Background: PubMed 28688597Olson 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.
- Background: PubMed 26122802COMMITTEE 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.
- Background: PubMed 26908666Siew 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.
- Background: PubMed 27450148Gattu 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.
- Background: PubMed 27328326Freeman 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.
- Background: PubMed 25662947Hemming 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dina Cortes, MD, DrMedSci study chair
Department of Pediatrics, Copenhagen University Hospital Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video triage in people with Telemedicine and Triage, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disposition (time frame: disposition is registered by the call operator immediately after the call.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03874520, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.