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

Primary Purpose

Covid19, Satisfaction, Patient, Telemedicine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine visit
In-person postoperative visit
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19 focused on measuring Covid19, Patient satisfaction, Telemedicine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cedars Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I

Group II

Arm Description

Patients who will undergo telemedicine visit approximately 1 week postoperatively, then an in-person clinic visit approximately 4 weeks postoperatively

Patients who will undergo in-person clinic visit approximately 1 week postoperatively, then a telemedicine visit approximately 4 weeks postoperatively

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
December 2, 2020
Last Updated
December 22, 2022
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04652674
Brief Title
Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic
Official Title
Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Satisfaction, Patient, Telemedicine
Keywords
Covid19, Patient satisfaction, Telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
Patients who will undergo telemedicine visit approximately 1 week postoperatively, then an in-person clinic visit approximately 4 weeks postoperatively
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Patients who will undergo in-person clinic visit approximately 1 week postoperatively, then a telemedicine visit approximately 4 weeks postoperatively
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine visit
Other Intervention Name(s)
Remote audio/video visit, telehealth visit
Intervention Description
A postoperative visit with the patient's surgeon conducted remotely via audio/video smartphone app
Intervention Type
Behavioral
Intervention Name(s)
In-person postoperative visit
Intervention Description
A standard-of-care in-person postoperatively visit with the patient's surgeon
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction score measured by electronic survey sent to all participating patients after their first postoperative visit
Time Frame
7 to 14 days postoperatively
Secondary Outcome Measure Information:
Title
Patient-reported rating of safety
Description
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
Time Frame
7 to 14 days postoperatively
Title
Length of visit
Description
Length of postoperative visit
Time Frame
7 to 14 days postoperatively
Title
Patient willingness to recommend provider to peers rated from 1 to 5
Description
Patient willingness to recommend provider to peers rated from 1 to 5
Time Frame
7 to 14 days postoperatively
Title
Combined patient satisfaction score from 1st and 2nd postoperative visits
Description
Combined patient satisfaction score from 1st and 2nd postoperative visits
Time Frame
7 to 31 days postoperatively
Title
Distance (in kilometers) of patient's primary residence to the clinic location
Description
Distance (in kilometers) of patient's primary residence to the clinic location
Time Frame
7 to 31 days postoperatively
Title
60-day rate of hospital readmission
Description
Incidence of hospital readmission 60 days postoperatively
Time Frame
60 days postoperatively
Title
60-day rate of re-operation
Description
Incidence of re-operation 60 days postoperatively
Time Frame
60 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Zaghiyan, MD
Organizational Affiliation
Associate Professor of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32675529
Citation
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.
Results Reference
background
PubMed Identifier
27016900
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.
Results Reference
background
PubMed Identifier
31350010
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.
Results Reference
background
PubMed Identifier
32336519
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.
Results Reference
background
PubMed Identifier
23842982
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.
Results Reference
background
PubMed Identifier
32324855
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.
Results Reference
background
Links:
URL
https://www.sealedenvelope.com/power/binary-noninferior/
Description
Sealed Envelope tool for randomization

Learn more about this trial

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

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