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

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04652674

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Satisfaction, Patient Telemedicine	Behavioral: Telemedicine visit Behavioral: In-person postoperative visit	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Sep 28, 2020

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient satisfaction [7 to 14 days postoperatively]
Patient satisfaction score measured by electronic survey sent to all participating patients after their first postoperative visit

Secondary Outcome Measures

Patient-reported rating of safety [7 to 14 days postoperatively]
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
Length of visit [7 to 14 days postoperatively]
Length of postoperative visit
Patient willingness to recommend provider to peers rated from 1 to 5 [7 to 14 days postoperatively]
Patient willingness to recommend provider to peers rated from 1 to 5
Combined patient satisfaction score from 1st and 2nd postoperative visits [7 to 31 days postoperatively]
Combined patient satisfaction score from 1st and 2nd postoperative visits
Distance (in kilometers) of patient's primary residence to the clinic location [7 to 31 days postoperatively]
Distance (in kilometers) of patient's primary residence to the clinic location
60-day rate of hospital readmission [60 days postoperatively]
Incidence of hospital readmission 60 days postoperatively
60-day rate of re-operation [60 days postoperatively]
Incidence of re-operation 60 days postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Principal Investigator: Karen Zaghiyan, MD, Associate Professor of Surgery

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Sealed Envelope tool for randomization

Publications

Responsible Party:

Karen Zaghiyan, Associate Professor of Surgery, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT04652674

Other Study ID Numbers:

STUDY00000944

First Posted:

Dec 3, 2020

Last Update Posted:

May 7, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karen Zaghiyan, Associate Professor of Surgery, Cedars-Sinai Medical Center

Covid19

Patient satisfaction

Telemedicine

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 7, 2021