Covid19NCT04652674
Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic
A study testing Telemedicine visit and In-person postoperative visit in people with Covid19 and Satisfaction, Patient, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this clinical study is to evaluate whether remote video/audio postoperative visits (telemedicine visits) affects patient satisfaction compared to in-person visits during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Satisfaction, Patient, Telemedicine
- What is being tested?
- Telemedicine visit and In-person postoperative visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 30 Jun 2022
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age inclusive at the time of the study who underwent colorectal surgery and are presenting for their first postoperative visit
- Patients with a computer or phone device with video and audio capabilities
Who cannot join
- Children <18 years of age
- Patients with mental disability
- Patients without a computer or phone device with video and audio capabilities
- Patients who require physical intervention during their first postoperative visit (e.g. drain removal, suture removal, staple removal)
- Patients who are readmitted to the hospital prior to their first postoperative visit will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
The purpose of this clinical study is to evaluate whether remote video/audio postoperative visits (telemedicine visits) affects patient satisfaction compared to in-person visits during the COVID-19 pandemic. If the primary objective of the study is achieved, it would allow better understanding of how telemedicine can be integrated into modern surgical practice to take care of postoperative patients.
- Conditions
- Covid19, Satisfaction, Patient, Telemedicine
- Being tested
- Telemedicine visit, In-person postoperative visit
- Keywords
- Covid19, Patient satisfaction, Telemedicine
- Medical subject headings
- COVID-19, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine visitBehavioural
Also called Remote audio/video visit, telehealth visit
A postoperative visit with the patient's surgeon conducted remotely via audio/video smartphone app
In-person postoperative visitBehavioural
A standard-of-care in-person postoperatively visit with the patient's surgeon
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients who will undergo telemedicine visit approximately 1 week postoperatively, then an in-person clinic visit approximately 4 weeks postoperatively Receives: Behavioral: Telemedicine visit |
| Group II | Active comparator | Patients who will undergo in-person clinic visit approximately 1 week postoperatively, then a telemedicine visit approximately 4 weeks postoperatively Receives: Behavioral: In-person postoperative visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction score measured by electronic survey sent to all participating patients after their first postoperative visit
Measured: 7 to 14 days postoperatively
Secondary outcomes (7)
Patient-reported rating of safety
Patient-reported sense of safety score rated from 1 to 5 with higher scores indicating greater sense of safety. This is designed to gauge how safe patients feel visiting the clinic in-person vs. online via telemedicine during the COVID pandemic
Measured: 7 to 14 days postoperatively
Length of visit
Length of postoperative visit
Measured: 7 to 14 days postoperatively
Patient willingness to recommend provider to peers rated from 1 to 5
Patient willingness to recommend provider to peers rated from 1 to 5
Measured: 7 to 14 days postoperatively
Combined patient satisfaction score from 1st and 2nd postoperative visits
Combined patient satisfaction score from 1st and 2nd postoperative visits
Measured: 7 to 31 days postoperatively
Distance (in kilometers) of patient's primary residence to the clinic location
Distance (in kilometers) of patient's primary residence to the clinic location
Measured: 7 to 31 days postoperatively
60-day rate of hospital readmission
Incidence of hospital readmission 60 days postoperatively
Measured: 60 days postoperatively
60-day rate of re-operation
Incidence of re-operation 60 days postoperatively
Measured: 60 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start28 Sep 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Zaghiyan, Cedars-Sinai Medical Center
- Investigators
- Karen Zaghiyan, MD, Principal investigator, Associate Professor of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652674
- Sponsor's protocol ID
- STUDY00000944
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2020
- Last updated
- 27 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grenda TR, Whang S, Evans NR 3rd. Transitioning a Surgery Practice to Telehealth During COVID-19. Ann Surg. 2020 Aug;272(2):e168-e169. doi: 10.1097/SLA.0000000000004008.
PubMed 32675529Gunter RL, Chouinard S, Fernandes-Taylor S, Wiseman JT, Clarkson S, Bennett K, Greenberg CC, Kent KC. Current Use of Telemedicine for Post-Discharge Surgical Care: A Systematic Review. J Am Coll Surg. 2016 May;222(5):915-27. doi: 10.1016/j.jamcollsurg.2016.01.062. Epub 2016 Feb 13. No abstract available.
PubMed 27016900Huang EY, Knight S, Guetter CR, Davis CH, Moller M, Slama E, Crandall M. Telemedicine and telementoring in the surgical specialties: A narrative review. Am J Surg. 2019 Oct;218(4):760-766. doi: 10.1016/j.amjsurg.2019.07.018. Epub 2019 Jul 18.
PubMed 31350010Hakim AA, Kellish AS, Atabek U, Spitz FR, Hong YK. Implications for the use of telehealth in surgical patients during the COVID-19 pandemic. Am J Surg. 2020 Jul;220(1):48-49. doi: 10.1016/j.amjsurg.2020.04.026. Epub 2020 Apr 21.
PubMed 32336519Hwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672.
PubMed 23842982Mann DM, Chen J, Chunara R, Testa PA, Nov O. COVID-19 transforms health care through telemedicine: Evidence from the field. J Am Med Inform Assoc. 2020 Jul 1;27(7):1132-1135. doi: 10.1093/jamia/ocaa072.
PubMed 32324855
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04652674
- Acronym / sponsor ID
- STUDY00000944
- Conditions
- Covid19, Satisfaction, Patient, Telemedicine
- Keywords
- Covid19, Patient satisfaction, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Dec 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 purpose of this clinical study is to evaluate whether remote video/audio postoperative visits (telemedicine visits) affects patient satisfaction compared to in-person visits during the COVID-19 pandemic. If the primary objective of the study is achieved, it would allow better understanding of how telemedicine can be integrated into modern surgical practice to take care of postoperative patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Behavioral: Telemedicine visitPatients who will undergo telemedicine visit approximately 1 week postoperatively, then an in-person clinic visit approximately 4 weeks postoperatively |
| Group II | Active comparator | Behavioral: In-person postoperative visitPatients who will undergo in-person clinic visit approximately 1 week postoperatively, then a telemedicine visit approximately 4 weeks postoperatively |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age inclusive at the time of the study who underwent colorectal surgery and are presenting for their first postoperative visit
- Patients with a computer or phone device with video and audio capabilities
Key exclusion criteria (5 listed)
- Children <18 years of age
- Patients with mental disability
- Patients without a computer or phone device with video and audio capabilities
- Patients who require physical intervention during their first postoperative visit (e.g. drain removal, suture removal, staple removal)
- Patients who are readmitted to the hospital prior to their first postoperative visit will be excluded.
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 |
|---|---|---|
| Telemedicine visitAlso: Remote audio/video visit, telehealth visitA postoperative visit with the patient's surgeon conducted remotely via audio/video smartphone app | Behavioural | Group I |
| In-person postoperative visitA standard-of-care in-person postoperatively visit with the patient's surgeon | Behavioural | Group II |
Primary outcome
Patient satisfaction
Time frame: 7 to 14 days postoperatively
Patient satisfaction score measured by electronic survey sent to all participating patients after their first postoperative visit
7 secondary outcomes
Patient-reported rating of safety
Time frame: 7 to 14 days postoperatively
Length of visit
Time frame: 7 to 14 days postoperatively
Patient willingness to recommend provider to peers rated from 1 to 5
Time frame: 7 to 14 days postoperatively
Combined patient satisfaction score from 1st and 2nd postoperative visits
Time frame: 7 to 31 days postoperatively
Distance (in kilometers) of patient's primary residence to the clinic location
Time frame: 7 to 31 days postoperatively
60-day rate of hospital readmission
Time frame: 60 days postoperatively
60-day rate of re-operation
Time frame: 60 days postoperatively
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 27 Dec 2022.
- Background: PubMed 32675529Grenda TR, Whang S, Evans NR 3rd. Transitioning a Surgery Practice to Telehealth During COVID-19. Ann Surg. 2020 Aug;272(2):e168-e169. doi: 10.1097/SLA.0000000000004008.
- Background: PubMed 27016900Gunter RL, Chouinard S, Fernandes-Taylor S, Wiseman JT, Clarkson S, Bennett K, Greenberg CC, Kent KC. Current Use of Telemedicine for Post-Discharge Surgical Care: A Systematic Review. J Am Coll Surg. 2016 May;222(5):915-27. doi: 10.1016/j.jamcollsurg.2016.01.062. Epub 2016 Feb 13. No abstract available.
- Background: PubMed 31350010Huang EY, Knight S, Guetter CR, Davis CH, Moller M, Slama E, Crandall M. Telemedicine and telementoring in the surgical specialties: A narrative review. Am J Surg. 2019 Oct;218(4):760-766. doi: 10.1016/j.amjsurg.2019.07.018. Epub 2019 Jul 18.
- Background: PubMed 32336519Hakim AA, Kellish AS, Atabek U, Spitz FR, Hong YK. Implications for the use of telehealth in surgical patients during the COVID-19 pandemic. Am J Surg. 2020 Jul;220(1):48-49. doi: 10.1016/j.amjsurg.2020.04.026. Epub 2020 Apr 21.
- Background: PubMed 23842982Hwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672.
- Background: PubMed 32324855Mann DM, Chen J, Chunara R, Testa PA, Nov O. COVID-19 transforms health care through telemedicine: Evidence from the field. J Am Med Inform Assoc. 2020 Jul 1;27(7):1132-1135. doi: 10.1093/jamia/ocaa072.
- CDC Guidelines for Healthcare FacilitiesLink provided by the sponsor.
- Sealed Envelope tool for randomizationLink provided by the sponsor.
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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.
Karen Zaghiyan, MD principal investigator
Associate Professor of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine visit and In-person postoperative visit in people with Covid19 and Satisfaction, Patient, run by Cedars-Sinai Medical Center 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 5 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 27 Dec 2022. 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?
Patient satisfaction (time frame: 7 to 14 days postoperatively). 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 NCT04652674, which also lists 6 linked publications.
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 27 Dec 2022.