Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic

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 Overview

• Status: Completed
• Conditions: Covid19; Satisfaction, Patient; Telemedicine
• Intervention / Treatment: Behavioral: Telemedicine visit; Behavioral: In-person postoperative visit

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Patients who will undergo telemedicine visit approximately 1 week postoperatively, then an in-person clinic visit approximately 4 weeks postoperatively	Behavioral: Telemedicine visit; A postoperative visit with the patient's surgeon conducted remotely via audio/video smartphone app; Other Names: Remote audio/video visit, telehealth visit
Active Comparator: Group II; Patients who will undergo in-person clinic visit approximately 1 week postoperatively, then a telemedicine visit approximately 4 weeks postoperatively	Behavioral: In-person postoperative visit; A standard-of-care in-person postoperatively visit with the patient's surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Length of visit	Length of postoperative visit	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	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	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	7 to 31 days postoperatively
60-day rate of hospital readmission	Incidence of hospital readmission 60 days postoperatively	60 days postoperatively
60-day rate of re-operation	Incidence of re-operation 60 days postoperatively	60 days postoperatively

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Karen Zaghiyan, MD, Associate Professor of Surgery

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Sealed Envelope tool for randomization

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Estimate): December 26, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Covid19; Patient satisfaction
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: STUDY00000944

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No