Telemedicine in the Generals Practitioners Office

• Conditions: Respiratory Distress Syndrome; Bronchiolitis; Pneumonia; Croup; Croup; False; Asthma; Bronchial Hyperreactivity
• Interventions: Device: Telemedicine

• Registration Number: NCT04168554
• Lead Sponsor: Rijnstate Hospital

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

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-18
• Last Update Submitted: 2019-11-18
• Study First Posted: 2019-11-19
• Last Update Posted: 2019-11-19
• Study Start: 2019-12
• Primary Completion: 2020-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase 1 and Phase 2	Telemedicine	20 patients studied in the emergency room with a pediatrician not presen in the ER performing the telemedicine examination from a distance (ie an office down the hall) followed directly by a face-to-face 20 patients included in the general practitioners office, telemedicine is performed from within the hospital to the GPs office. Patient is then still referred to the hospital in order to check whether the telemedicine and face-to-face examination are somewhat similarce physical examination

Primary Outcome Measures

Name	Time	Method
Discharge or admitted?	within 30-60 minutes after inclusion	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"
Respiratory Observation Scale	within 30-60 minutes after inclusion	Observe the presence of: tachypnea, nasal flaring, perioral cyanosis, tripoding, thoracoabdominal asynchrony, supraclavicular-, substernal- or intercostal retractions, mental status and patient in respiratory distress

Secondary Outcome Measures

Name	Time	Method
Patient reported experience measure	within 60 minutes after telemedicine evaluation	questionnaire on patient / parent satisfaction with regard to the telemedicine
Doctor reported experience measure	within 4 weeks after inclusion of patients	Interview with participating doctors with regard to satisfaction of the telemedicine