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

Covid19 Clinical Trial

— TelemedCov  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990570
• Other study ID #: Al-AzharTelemedicineinCovid-19
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1396
• Est. completion date: July 31, 2021
• Est. primary completion date: June 7, 2020
• Gender: All
• Age group: 1 Month to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Pandemic
• Telemedicine
• Virtual Clinic

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	Muhammad Elsayed Abdelhafez Mahmoud	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
dr. Muhammad Abdelhafez Mahmoud, MD

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age of patients	Age in years	1 year
Primary	Condition distribution	Condition distribution in percentage	1 year
Primary	Conversation duration	Conversation duration in minutes	1 year
Primary	Attendance rate	Attendance rate in percentage	1 year
Primary	Cancellation rate	Cancellation rate in percentage	1 year
Primary	Rate of re-admissions	Rate of re-admissions in percentage	1 year
Secondary	Ultimate fate of the interview	Ultimate fate of the interview in ratio	1 year
Secondary	Patient satisfaction questionnaire	Patient satisfaction degree in numbers	1 year