COVIDNCT04376710
Surgical Telemedicine in the COVID-19 Pandemic Era
An observational study of COVID and Surgery, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The current COVID-19 pandemic has caused delays in initial or follow-up encounters between surgical patients and physicians. While this delay allows for resource allocation to those most severely affected by the pandemic, surgeons are faced with potential important delays in diagnosis and the expanding backlog of… Read more about this study
- Who is it for?
- Ages 31 days to 18 yearsHealthy volunteers can take part
- What is being tested?
- Completion of pre-pandemic survey, Completion of survey after peak of pandemic and Completion of post telemedicine encounter survey
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 1 Oct 2020
- 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 31 days to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Surgical faculty at participating institutions will be able to complete pre and post pandemic surveys regarding telemedicine and barriers to implementation. Surgical patients who complete a telemedicine encounter from the start of the study through a 6-month period will be included in the study. They will be able to complete an optional anonymous survey regarding perceptions to telemedicine and perceived barriers to implementation.
Who may be able to join
- Surgical faculty at participating institutions will receive surveys regarding telemedicine early in the start of the study to assess baseline perceptions. These same group of surgeons will receive subsequent surveys 3 months after the peak of the pandemic to evaluate telemedicine perceptions following a rapid implementation and adoption of telemedicine.
- Surgical patients evaluated from the start of the study through a 6-month period will be included in the study. They will have the option after each telemedicine encounter to complete an anonymous survey regarding perceptions to this technology.
Who cannot join
- No exclusions for surgical faculty are identified. Accrual of data from this group will be limited only by response rates to administered surveys.
- Exclusions for surgical patients will include the inability to access the technology required for a telemedicine consultation (e.g.: absence of a camera enabled smartphone, absence of a required internet or cellular connection to perform a telemedicine encounter). The investigators will keep a list of reasons for the inability to perform a telemedicine encounter to identify the barriers to implementation among patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
The current COVID-19 pandemic has caused delays in initial or follow-up encounters between surgical patients and physicians. While this delay allows for resource allocation to those most severely affected by the pandemic, surgeons are faced with potential important delays in diagnosis and the expanding backlog of elective cases and initial evaluations.
This project will assess surgeon and patient telemedicine perspectives. Pre-pandemic views on telemedicine among a cohort of surgeons will be obtained and compared to views at 3 months from the peak of the pandemic. Patients will be surveyed following telemedicine appointments with an anonymous questionnaire to learn about patient receptiveness to telemedicine. Barriers to implementation will be addressed throughout the duration of the study.
- Being tested
- Completion of pre-pandemic survey, Completion of survey after peak of pandemic, Completion of post telemedicine encounter survey
- Keywords
- Telemedicine, COVID, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of pre-pandemic surveyOther
Surgeons will take a pre-pandemic survey to determine surgeon perceptions to telemedicine and barriers to implementation.
Completion of survey after peak of pandemicOther
Surgeons will take another survey after the peak of pandemic to determine surgeon perceptions to telemedicine and barriers to implementation.
Completion of post telemedicine encounter surveyOther
Patients will take a post telemedicine encounter survey to determine patient perceptions to telemedicine and barriers to implementation.
| Study group | Role | What they receive |
|---|---|---|
| Surgeons | Not described Receives: Other: Completion of pre-pandemic survey; Other: Completion of survey after peak of pandemic | |
| Patients | Not described Receives: Other: Completion of post telemedicine encounter survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate surgeon perceptions to telemedicine and perceived barriers to implementation
Surgeons will take an anonymous survey early after the start of the study regarding perceptions to telemedicine and perceived barriers to implementation. Surgeons will be asked again after 3 months from the peak of the pandemic to take another survey to assess how the pandemic has changed perceptions to telemedicine and the observed barriers to implementation.
Measured: 6 months
Evaluate patient perceptions to telemedicine and perceived barriers to implementation
Patients will take an optional anonymous survey at the end of each telemedicine encounter to assess patient perceptions to telemedicine and barriers to implementation.
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 posted6 May 2020
- Study start1 Jul 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376710
- Sponsor's protocol ID
- 20-1177
- Status last verified
- Oct 2020
- First submitted
- 4 May 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for IPD.
Publications
Diaz-Miron J, Ogle S, Kaizer A, Acker SN, Rove KO, Inge TH. Surgeon, patient, and caregiver perspective of pediatric surgical telemedicine in the COVID-19 pandemic era. Pediatr Surg Int. 2022 Feb;38(2):241-248. doi: 10.1007/s00383-021-05016-8. Epub 2021 Sep 22.
PubMed 34550442
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Telemedicine in the COVID-19 Pandemic Era
- ClinicalTrials.gov ID
- NCT04376710
- Acronym / sponsor ID
- 20-1177
- Keywords
- Telemedicine, COVID, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 6 May 2020 (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.
The current COVID-19 pandemic has caused delays in initial or follow-up encounters between surgical patients and physicians. While this delay allows for resource allocation to those most severely affected by the pandemic, surgeons are faced with potential important delays in diagnosis and the expanding backlog of elective cases and initial evaluations.
This project will assess surgeon and patient telemedicine perspectives. Pre-pandemic views on telemedicine among a cohort of surgeons will be obtained and compared to views at 3 months from the peak of the pandemic. Patients will be surveyed following telemedicine appointments with an anonymous questionnaire to learn about patient receptiveness to telemedicine. Barriers to implementation will be addressed throughout the duration of the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeons | – | Other: Completion of pre-pandemic survey, Other: Completion of survey after peak of pandemic |
| Patients | – | Other: Completion of post telemedicine encounter survey |
Who may qualify
- Ages
- 31 days to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Surgical faculty at participating institutions will be able to complete pre and post pandemic surveys regarding telemedicine and barriers to implementation. Surgical patients who complete a telemedicine encounter from the start of the study through a 6-month period will be included in the study. They will be able to complete an optional anonymous survey regarding perceptions to telemedicine and perceived barriers to implementation.
Key inclusion criteria (2 listed)
- Surgical faculty at participating institutions will receive surveys regarding telemedicine early in the start of the study to assess baseline perceptions. These same group of surgeons will receive subsequent surveys 3 months after the peak of the pandemic to evaluate telemedicine perceptions following a rapid implementation and adoption of telemedicine.
- Surgical patients evaluated from the start of the study through a 6-month period will be included in the study. They will have the option after each telemedicine encounter to complete an anonymous survey regarding perceptions to this technology.
Key exclusion criteria (2 listed)
- No exclusions for surgical faculty are identified. Accrual of data from this group will be limited only by response rates to administered surveys.
- Exclusions for surgical patients will include the inability to access the technology required for a telemedicine consultation (e.g.: absence of a camera enabled smartphone, absence of a required internet or cellular connection to perform a telemedicine encounter). The investigators will keep a list of reasons for the inability to perform a telemedicine encounter to identify the barriers to implementation among patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion of pre-pandemic surveySurgeons will take a pre-pandemic survey to determine surgeon perceptions to telemedicine and barriers to implementation. | Other | Surgeons |
| Completion of survey after peak of pandemicSurgeons will take another survey after the peak of pandemic to determine surgeon perceptions to telemedicine and barriers to implementation. | Other | Surgeons |
| Completion of post telemedicine encounter surveyPatients will take a post telemedicine encounter survey to determine patient perceptions to telemedicine and barriers to implementation. | Other | Patients |
Primary outcome
Evaluate surgeon perceptions to telemedicine and perceived barriers to implementation
Time frame: 6 months
Surgeons will take an anonymous survey early after the start of the study regarding perceptions to telemedicine and perceived barriers to implementation. Surgeons will be asked again after 3 months from the peak of the pandemic to take another survey to assess how the pandemic has changed perceptions to telemedicine and the observed barriers to implementation.
Evaluate patient perceptions to telemedicine and perceived barriers to implementation
Time frame: 6 months
Patients will take an optional anonymous survey at the end of each telemedicine encounter to assess patient perceptions to telemedicine and barriers to implementation.
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 28 Oct 2020.
- Derived from this study: PubMed 34550442Diaz-Miron J, Ogle S, Kaizer A, Acker SN, Rove KO, Inge TH. Surgeon, patient, and caregiver perspective of pediatric surgical telemedicine in the COVID-19 pandemic era. Pediatr Surg Int. 2022 Feb;38(2):241-248. doi: 10.1007/s00383-021-05016-8. Epub 2021 Sep 22.
- Individual participant dataSharing planned: No. No plan for IPD.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID and Surgery, run by University of Colorado, Denver at 1 site in United States.
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 2 inclusion and 2 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 28 Oct 2020. 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 United States. 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?
Evaluate surgeon perceptions to telemedicine and perceived barriers to implementation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376710, which also lists 1 linked publication.
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 28 Oct 2020.