Clinical trial NCT04168554: Telemedicine in the Generals Practitioners Office
Official title: Pilotonderzoek Naar Het Gebruik Van Telemedicine Bij Het Beoordelen Van Het Benauwde Kind in de Huisartsenpraktijk English: The Use of Telemedicine in the General Practitioners Office for a Child With Respiratory Symptoms: a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome
Pneumonia
Bronchiolitis
Croup
Croup; False
Asthma
Bronchial Hyperreactivity
Keywords: Telemedicine
Respiratory distress
Pediatric
General practitioner
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with any type of respiratory disease

Brief summary: Pediatrician does physical examination through telemedicine and in real life to see whether the telemedicine consultation corresponds with the real life examination.

Goal is to determine:

1. Check practical feasability
2. Check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much more unreliable to do a physical examination a larger study is deemed unsafe)

Detailed description: 40 pediatric patients seen by a general practitioner (GP) whom the GP has referred or wants to refer to a pediatrician for clinical evaluation are included in this study.

Study is designed in 2 parts. Part 1 is at the emergency room in the hospital Part 2 is at the GPs office

The pediatrician sees the patient through a telemedicine consultation. Then sees the patient in real life to see if what was seen during telemedicine corresponds with the real life consultation.

With telemedicine and real life consultation the pediatrician rates the patient as either a candidate to go home or to be admitted. With the telemedicine consultation there is also an option "in doubt: i want to see the patient in real life".

Also with both telemedicine and real life examination the pediatrician scores the patient using the respiratory observation scale (Siew et al, 2016)

Goal is to:

1. Check practical feasability
2. Check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much harder to do a physical examination

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with respiratory symptoms whom are referred by a general practitioner to be evaluated by a pediatrician

Exclusion Criteria:

* Infants younger than 2 months of age
* 19 years and older
* Ex-premature with post-conceptional age \<48 weeks
* Congenital heart disease
* Down Syndrome
* Immune deficiency
* Pre-existent pulmonary disorder (Broncho-pulmonary dysplasia, Cystic Fibrosis)
* Pre-existent neurological disorders
* Apnea's
* Patients with respiratory distress with dehydration symptoms
* Patients who have already been treated with salbutamol inhalers of nebulizer - Emergency patient with respiratory insufficiency
* Technical problems which cause a delay longer than 10 minutes before a video-connection is made
* expected delay before commencing telemedicine consultation of longer than 30 minutes

Primary outcomes:
measure: Discharge or admitted?
timeFrame: within 30-60 minutes after inclusion
measure: Respiratory Observation Scale
timeFrame: within 30-60 minutes after inclusion
Secondary outcomes:
measure: Patient reported experience measure
timeFrame: within 60 minutes after telemedicine evaluation
measure: Doctor reported experience measure
timeFrame: within 4 weeks after inclusion of patients
Other outcomes:
Locations:
Study officials:
affiliation: Rijnstate Hospital
name: Margreet Wessels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.