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CompletedNCT04990570TelemedCovUpdated Aug 20, 2021

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

An observational study in Telemedicine, Virtual Clinic and Covid19, sponsored by dr. Muhammad Abdelhafez Mahmoud, MD. Completed at 1 site in Saudi Arabia. Open to participants aged 1 Month to 14 Years. Per ClinicalTrials.gov, last updated 2021-08-20.

Sponsored by dr. Muhammad Abdelhafez Mahmoud, MD · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,396
Ages
1 Month to 14 Years
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Telemedicine
  • Virtual Clinic
  • Covid19
  • Pandemic

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Keywords

  • Telemedicine;
  • Covid-19 Pandemic;
  • Pediatric Surgery;
  • Children;
  • Video Conversation;
  • Patient's Privacy;
  • Data Security
  • Health-care Service
  • Day-case Surgery
03

Who can participate

Ages eligible
1 Month to 14 Years
Sexes eligible
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

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

Exclusion Criteria:

  • Patients older than 14 yrs of age
  • Parents/patients refuse this method of interaction
  • Equipment shortage
  • Poor internet connection
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,396 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherTelemedicine 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.

05

What researchers measure

Primary outcomes

  1. Age of patients

    Age in years

    Time frame: 1 year

  2. Condition distribution

    Condition distribution in percentage

    Time frame: 1 year

  3. Conversation duration

    Conversation duration in minutes

    Time frame: 1 year

  4. Attendance rate

    Attendance rate in percentage

    Time frame: 1 year

  5. Cancellation rate

    Cancellation rate in percentage

    Time frame: 1 year

  6. Rate of re-admissions

    Rate of re-admissions in percentage

    Time frame: 1 year

Secondary outcomes

  1. Ultimate fate of the interview

    Ultimate fate of the interview in ratio

    Time frame: 1 year

  2. Patient satisfaction questionnaire

    Patient satisfaction degree in numbers

    Time frame: 1 year

06

Study locations

1 site
  • Muhammad Elsayed Abdelhafez Mahmoud
    Riyadh, 14213, Saudi Arabia
07

References and documents

Individual participant data

Plan to share: Yes — Data are available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study add to the literature

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04990570
Lead sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
Responsible party
dr. Muhammad Abdelhafez Mahmoud, MD (Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine, Al-Azhar University) — Sponsor-investigator
First posted
Aug 4, 2021
Start date
Jun 1, 2019
Primary completion
Jun 7, 2020
Completion
Jul 31, 2021
Last update
Aug 20, 2021

Study contacts

Muhammad Elsayed AH Mahmoud, MD
principal investigator · Al-Azhar University, Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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