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Completed

NCT Number: NCT04990570

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

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

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Key information

Age range

1 month–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Muhammad Elsayed Abdelhafez Mahmoud

Riyadh, 14213, Saudi Arabia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine in the form Virtual clinic via video consultation

Other

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.

Primary outcomes

  1. Age of patients

    Time frame: 1 year

    Age in years

  2. Condition distribution

    Time frame: 1 year

    Condition distribution in percentage

  3. Conversation duration

    Time frame: 1 year

    Conversation duration in minutes

  4. Attendance rate

    Time frame: 1 year

    Attendance rate in percentage

  5. Cancellation rate

    Time frame: 1 year

    Cancellation rate in percentage

  6. Rate of re-admissions

    Time frame: 1 year

    Rate of re-admissions in percentage

Secondary outcomes

  1. Ultimate fate of the interview

    Time frame: 1 year

    Ultimate fate of the interview in ratio

  2. Patient satisfaction questionnaire

    Time frame: 1 year

    Patient satisfaction degree in numbers

Sponsors and collaborators

Lead sponsor

dr. Muhammad Abdelhafez Mahmoud, MD

Other

Registry information

Official study 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

Acronym: TelemedCov

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 4, 2021
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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