Telemedicine (Virtual Clinic) for Pediatric Surgery During Covid-19 Pandemic (TelemedCov)

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

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

Study Overview

• Status: Completed
• Conditions: Covid19; Telemedicine; Pandemic; Virtual Clinic
• Intervention / Treatment: Other: Telemedicine in the form Virtual clinic via video consultation

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.

• Study Type: Observational
• Enrollment (Actual): 1396

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 14213
    • Muhammad Elsayed Abdelhafez Mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 14 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric day-case surgical patients, encountered via Virtual clinic from June 2020 till July 2021; Pediatric patients, with age ranging from 1 month-14 years, with day-case surgical problems, encountered during the era of Covid-19 pandemic. Telemedicine, in the form of Virtual clinic, was utilized to address this distressing problem, to aid in conveying their concerns and bridge the gap in surgeon-patient relationship & encounter.	Other: Telemedicine in the form Virtual clinic via video consultation; Pediatric patients, with age ranging from 1 month-14 years, with surgical problems, encountered during the era of Covid-19 pandemic. Some of them seen at the OPD clinic, while the majority failed to attend because of Covid-19 associated lock-down and Curfew, thus, rendering their approach to the service. Telemedicine, in the form of Virtual clinic, was utilized to address the distressing problem of difficult approach of patients to the pedia surgery OPD because of Covid-19 pandemic restrictive regulatory precautions, to aid in conveying their concerns and bridge the gap in surgeon-patient relationship & encounter.
Control group comprising of patients scheduled to the OPD clinic from June 2019 till June 2020; Cases of office OPD appointments in the period from June 2019 till June 2020 will be included as a control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of patients	Age in years	1 year
Condition distribution	Condition distribution in percentage	1 year
Conversation duration	Conversation duration in minutes	1 year
Attendance rate	Attendance rate in percentage	1 year
Cancellation rate	Cancellation rate in percentage	1 year
Rate of re-admissions	Rate of re-admissions in percentage	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultimate fate of the interview	Ultimate fate of the interview in ratio	1 year
Patient satisfaction questionnaire	Patient satisfaction degree in numbers	1 year

Collaborators and Investigators

• Sponsor: dr. Muhammad Abdelhafez Mahmoud, MD
• Investigators: Principal Investigator: Muhammad Elsayed AH Mahmoud, MD, Al-Azhar University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): June 7, 2020
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 14, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine;; Covid-19 Pandemic;; Pediatric Surgery;; Children;; Video Conversation;; Patient's Privacy;; Data Security; Health-care Service; Day-case Surgery
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Al-AzharTelemedicineinCovid-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature
• IPD Sharing Time Frame: August 2021 till indefinitely
• IPD Sharing Access Criteria: Send a request to the study principal-investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No