Telemedicine in the Generals Practitioners Office

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

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)

Study Overview

• Status: Unknown
• Conditions: Pneumonia; Asthma; Respiratory Distress Syndrome; Bronchiolitis; Bronchial Hyperreactivity; Croup; Croup; False
• Intervention / Treatment: 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:

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Mendel Ottow, Drs, MD; Phone Number: +31880058888; Email: mottow@rijnstate.nl
• Study Contact Backup: Name: Margreet Wessels, MD, PhD; Phone Number: +31880058888; Email: secretariaatkindergeneeskunde@rijnstate.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with any type of respiratory disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Margreet Wessels, MD, PhD, Rijnstate Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (ACTUAL): November 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Telemedicine; Pediatric; Respiratory distress; General practitioner
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Infant, Premature, Diseases; Bronchitis; Laryngeal Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchiolitis; Bronchial Hyperreactivity; Laryngitis; Croup
• Other Study ID Numbers: 2019-1384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes