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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04652674
Other study ID # STUDY00000944
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2020
Est. completion date June 30, 2022

Study information

Verified date December 2022
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. 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 2. Patients with a computer or phone device with video and audio capabilities Exclusion Criteria: 1. Children <18 years of age 2. Patients with mental disability 3. Patients without a computer or phone device with video and audio capabilities 4. Patients who require physical intervention during their first postoperative visit (e.g. drain removal, suture removal, staple removal) 5. Patients who are readmitted to the hospital prior to their first postoperative visit will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telemedicine visit
A postoperative visit with the patient's surgeon conducted remotely via audio/video smartphone app
In-person postoperative visit
A standard-of-care in-person postoperatively visit with the patient's surgeon

Locations

Country Name City State
United States Cedars Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Gunter 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. — View Citation

Hakim 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. — View Citation

Huang 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. — View Citation

Hwa 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. — View Citation

Mann 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patient satisfaction Patient satisfaction score measured by electronic survey sent to all participating patients after their first postoperative visit 7 to 14 days postoperatively
Secondary 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 7 to 14 days postoperatively
Secondary Length of visit Length of postoperative visit 7 to 14 days postoperatively
Secondary Patient willingness to recommend provider to peers rated from 1 to 5 Patient willingness to recommend provider to peers rated from 1 to 5 7 to 14 days postoperatively
Secondary Combined patient satisfaction score from 1st and 2nd postoperative visits Combined patient satisfaction score from 1st and 2nd postoperative visits 7 to 31 days postoperatively
Secondary Distance (in kilometers) of patient's primary residence to the clinic location Distance (in kilometers) of patient's primary residence to the clinic location 7 to 31 days postoperatively
Secondary 60-day rate of hospital readmission Incidence of hospital readmission 60 days postoperatively 60 days postoperatively
Secondary 60-day rate of re-operation Incidence of re-operation 60 days postoperatively 60 days postoperatively
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