Telemedicine in the Generals Practitioners Office

Asthma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04168554
• Other study ID #: 2019-1384
• Status: Not yet recruiting
• Start date: December 2019
• Est. completion date: November 2020

Study information

• Verified date: November 2019
• Source: Rijnstate Hospital
• Contact: Mendel Ottow, Drs, MD
• Phone: +31880058888
• Email: mottow[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Hyperreactivity
• Bronchiolitis
• Croup
• Croup; False
• Pneumonia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Telemedicine
Patient is examined using telemedicine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discharge or admitted?	Patients are categorized in one of three categories through telemedicine-evaluation Group 1: "Patient can safely go home" Group 2: "Patient will need to be admitted" Group 3: "In doubt between group 1 and group 2, emergency room consultation required" FTF evaluation: Group 1: "Patient can safely go home" Group 2: "Patient will need to be admitted"	within 30-60 minutes after inclusion
Primary	Respiratory Observation Scale	Observe the presence of: tachypnea, nasal flaring, perioral cyanosis, tripoding, thoracoabdominal asynchrony, supraclavicular-, substernal- or intercostal retractions, mental status and patient in respiratory distress	within 30-60 minutes after inclusion
Secondary	Patient reported experience measure	questionnaire on patient / parent satisfaction with regard to the telemedicine	within 60 minutes after telemedicine evaluation
Secondary	Doctor reported experience measure	Interview with participating doctors with regard to satisfaction of the telemedicine	within 4 weeks after inclusion of patients