Clinical trial NCT04990570: Telemedicine (Virtual Clinic) for Pediatric Surgery During Covid-19 Pandemic
Official title: Telemedicine (Virtual Clinic) Effectively Delivers the Required Health-care Service for Pediatric Day-case Surgical Patients in the Current Era of Covid -19 Pandemic: A Non-randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Telemedicine
Virtual Clinic
Covid19
Pandemic
Keywords: Telemedicine;
Covid-19 Pandemic;
Pediatric Surgery;
Children;
Video Conversation;
Patient's Privacy;
Data Security
Health-care Service
Day-case Surgery
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 1396
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric surgical patients, with age ranging from 1 month till 14 yrs old, in need to surgical consultation and further management of their issues in the era of Covid-19 pandemic, with the majority being rendered from approach to the OPD because of Covid-19 associated regulatory precautions notably lockdown period and Curfew

Brief summary: Telemedicine (Virtual Clinic) Effectively Delivers the Required Health-care Service to Pediatric Day-case Surgical Patients in the Current Era of Covid-19 Pandemic: A Non-randomized Controlled Study

Detailed description: Children often get sick, either from congenital or acquired lesions. The Covid-19 associated regulatory precautions had made the process of seeking medical advice getting more difficult and much challenging. In this article, we aim to present our experience in utilization of telemedicine, specifically the virtual clinic via video consultation, in sorting and guiding the pediatric surgical patients, evaluate the effectiveness, and document its results in giving a convenient solution for this heavily distressing problem.

Materials and Methods:

This prospective study addressed the utilization of telemedicine, specifically the virtual clinic via video consultation in the field of pediatric surgery in the current era of Covid-19 pandemic. Data recorded for analysis included demographic data, condition distribution (system/body region affected), conversation duration, ultimate fate of the consultations. Service was evaluated by on-line patient questionnaire ranging from 1 to 5.

Study was carried out at 3 pediatric surgery tertiary centers (Prince Mohammed bin Abdulaziz Hospital in Riyadh, Alyamamah Obstetric \& Children's hospital in Riyadh, and Al-Azhar University hospitals in Cairo) on pediatric surgical patients, in the period from June 2020 to July 2021, in comparison to the statistics of the period from June 2019 till June 2020. All patients' guardians enrolled in the study had electronically signed a written informed consent before commencement of a video consultation. The study was approved by the Institutional Review Board and ethics committee (Registration number: H7D4-2020-0051E). The main objective was to assess the efficacy utilization of telemedicine (mainly virtual clinic via video consultation) in sorting and correct guiding of children with surgical issues. Primary outcome measurements included attendance rate, cancellation rate, re-admission rate, and parent/patients' satisfaction. Secondary outcome measurements included time interval from appointment request till the actual encounter, encounter duration, and fate of the video conversations.

All patients are requested to register in the MOH registry (including ID and phone numbers, address, \& e-mail), and are given instructions on how to use the certified applications to organize their access to the service via approved applications at any time. Also, on-call pediatric surgery specialists were ready all the time.

Telemedicine (virtual clinic via video consultation), between a well-trained expert pediatric surgeon and a motivated child's caregiver, effectively bridges the gap caused by the regulatory precautions mandated by the current Covid-19 pandemic.

Statistical analysis:

It will be performed with IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp. Data will be presented as mean, standard deviation, number \& percentage, using Chi-squared test (X2) for qualitative data. The significance level will be set at P \> 0.05.

- Discussion will focus on demonstrating and achieving the main objective that was to assess the efficacy utilization of telemedicine (mainly virtual clinic via video consultation) in sorting and correct guiding of children with surgical issues. Points of discussion will include attendance rate, cancellation rate, re-admission rate, and parent/patients' satisfaction, fate of the video conversations.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients, with surgical conditions or consultations
* Mindful parents, motivated to use this remote interaction technology
* Available equipment (smart phone, computer or laptop, or tablet and strong stable internet connection with Ethernet coverage)

Exclusion Criteria:

* Patients older than 14 yrs of age
* Parents/patients refuse this method of interaction
* Equipment shortage
* Poor internet connection

Primary outcomes:
measure: Age of patients
timeFrame: 1 year
measure: Condition distribution
timeFrame: 1 year
measure: Conversation duration
timeFrame: 1 year
measure: Attendance rate
timeFrame: 1 year
measure: Cancellation rate
timeFrame: 1 year
measure: Rate of re-admissions
timeFrame: 1 year
Secondary outcomes:
measure: Ultimate fate of the interview
timeFrame: 1 year
measure: Patient satisfaction questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Muhammad Elsayed Abdelhafez Mahmoud
Study officials:
affiliation: Al-Azhar University, Faculty of Medicine
name: Muhammad Elsayed AH Mahmoud, MD
role: PRINCIPAL_INVESTIGATOR
References: