TelehealthNCT04736680
Pediatric Virtual Visits as a Strategy for Access to Care During the COVID-19 Pandemic in a Pediatric Hospital
An observational study of Telehealth, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
Trial summary
In this study we will describe the factors associated with missed virtual visit appointments in an academic children´s hospital during the covid-19 pandemic and we will develop a predictive model that serves as the basis for improving the Telehealth Program. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Telehealth
- How many people
- 3,339 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Mar 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All scheduled virtual visit appointments between August 1 2020 and 31 december 2020 will be included. The sample will be randomized to allocate a generation cohort (two-thirds of the sample) and a validation cohort (one third of the sample).
Who may be able to join
- All scheduled virtual visits
Who cannot join
- On-call virtual visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Virtual Visits as a Strategy for Access to Care During the COVID-19 Pandemic in a Pediatric Hospital. Missed Appointments Rates, Associated Factors, Generation and Validation of Predictive Models
In this study we will describe the factors associated with missed virtual visit appointments in an academic children´s hospital during the covid-19 pandemic and we will develop a predictive model that serves as the basis for improving the Telehealth Program.
Read the detailed description
Pediatric visits are a fundamental axis of health policies because actions to promote and protect health have a maximum effect on children. Due to the COVID-19 pandemic a marked decrease in pediatric visits was observed in scheduled and on-call visits. This fact can be explained by the restriction on people's circulation necessary to contain COVID-19 dissemination. In this context, the population that attends the Hospital General de Niños Pedro de Elizalde was especially affected, since 91% of the patients attending the institution live in another district.
In order to overcome this barrier in access to care, we decided to implement a Telehealth Program that uses virtual visits as a tool for access to care. Little is known about the effects that these programs can have on patients with exclusive public health coverage. Although virtual visits could be a solution for access to care in an oversaturated system, there is the possibility that virtual visits could not be carried out and that a significant proportion will be lost, increasing inequity and difficulties in access to health.
Due to the relevance of the topic and the little information available, we propose in this study to estimate the proportion of virtual visits appointments lost. On the other hand, considering the possibility of avoiding the loss of virtual visits appointments, we propose to describe the factors associated with missed appointments and develop a predictive model that serves as the basis for improving the Telehealth Program.
- Conditions
- Telehealth
- Keywords
- Telehealth, Children, COVID-19, virtual visit, Lost appointments
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lost Virtual Visit | Pediatric patients who had scheduled an appointment for a virtual visit and missed. | |
| Attended Virtual Visit | Pediatric patients who had scheduled an appointment for a virtual visit and attended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of missed appointments
Characterize, describe and compare the clinical and administrative characteristics of outpatients who didn't attend and attended an appointment in pediatrics
Measured: 6 months
Secondary outcomes (1)
Clinical and administrative characteristics
Characterize, describe and compare the clinical and administrative characteristics of outpatients who didn't attend and attended an appointment in pediatrics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelehealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano E Ibarra, MD, Principal investigator, Hospital General de Niños Pedro de Elizalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736680
- Sponsor's protocol ID
- 2392
- Status last verified
- Sep 2021
- First submitted
- 1 Feb 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Virtual Visits as a Strategy for Access to Care During the COVID-19 Pandemic in a Pediatric Hospital. Missed Appointments Rates, Associated Factors, Generation and Validation of Predictive Models
- ClinicalTrials.gov ID
- NCT04736680
- Acronym / sponsor ID
- 2392
- Conditions
- Telehealth
- Keywords
- Telehealth, Children, COVID-19, virtual visit, Lost appointments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,339 participants (actual)
- Lead sponsor
- Hospital General de Niños Pedro de ElizaldeUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we will describe the factors associated with missed virtual visit appointments in an academic children´s hospital during the covid-19 pandemic and we will develop a predictive model that serves as the basis for improving the Telehealth Program.
Detailed description
Pediatric visits are a fundamental axis of health policies because actions to promote and protect health have a maximum effect on children. Due to the COVID-19 pandemic a marked decrease in pediatric visits was observed in scheduled and on-call visits. This fact can be explained by the restriction on people's circulation necessary to contain COVID-19 dissemination. In this context, the population that attends the Hospital General de Niños Pedro de Elizalde was especially affected, since 91% of the patients attending the institution live in another district.
In order to overcome this barrier in access to care, we decided to implement a Telehealth Program that uses virtual visits as a tool for access to care. Little is known about the effects that these programs can have on patients with exclusive public health coverage. Although virtual visits could be a solution for access to care in an oversaturated system, there is the possibility that virtual visits could not be carried out and that a significant proportion will be lost, increasing inequity and difficulties in access to health.
Due to the relevance of the topic and the little information available, we propose in this study to estimate the proportion of virtual visits appointments lost. On the other hand, considering the possibility of avoiding the loss of virtual visits appointments, we propose to describe the factors associated with missed appointments and develop a predictive model that serves as the basis for improving the Telehealth Program.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lost Virtual Visit | – | –Pediatric patients who had scheduled an appointment for a virtual visit and missed. |
| Attended Virtual Visit | – | –Pediatric patients who had scheduled an appointment for a virtual visit and attended. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All scheduled virtual visit appointments between August 1 2020 and 31 december 2020 will be included. The sample will be randomized to allocate a generation cohort (two-thirds of the sample) and a validation cohort (one third of the sample).
Key inclusion criteria (1 listed)
- All scheduled virtual visits
Key exclusion criteria (1 listed)
- On-call virtual visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of missed appointments
Time frame: 6 months
Characterize, describe and compare the clinical and administrative characteristics of outpatients who didn't attend and attended an appointment in pediatrics
1 secondary outcome
Clinical and administrative characteristics
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariano E Ibarra, MD principal investigator
Hospital General de Niños Pedro de Elizalde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Telehealth, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of missed appointments (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.