Telemedicine in the Generals Practitioners Office

Sponsor

Rijnstate Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04168554

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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:

Check practical feasability
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)

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome Pneumonia Bronchiolitis Croup Croup; False Asthma Bronchial Hyperreactivity	Device: Telemedicine

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:

Check practical feasability
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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

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

Anticipated Study Start Date :

Dec 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Phase 1 and Phase 2 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	Device: Telemedicine Patient is examined using telemedicine

Arm

Intervention/Treatment

Phase 1 and Phase 2

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

Device: Telemedicine

Patient is examined using telemedicine

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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