NCT04652674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

December 2, 2020

Last Update Submit

December 22, 2022

Conditions

Keywords

Covid19Patient satisfactionTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Patient-reported rating of safety

    7 to 14 days postoperatively

  • Length of visit

    7 to 14 days postoperatively

  • 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

    7 to 31 days postoperatively

  • Distance (in kilometers) of patient's primary residence to the clinic location

    7 to 31 days postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Group I

EXPERIMENTAL

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

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

Behavioral: In-person postoperative visit

Interventions

A postoperative visit with the patient's surgeon conducted remotely via audio/video smartphone app

Also known as: Remote audio/video visit, telehealth visit
Group I

A standard-of-care in-person postoperatively visit with the patient's surgeon

Group II

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related 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.

    PMID: 32675529BACKGROUND
  • 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.

    PMID: 27016900BACKGROUND
  • 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.

    PMID: 31350010BACKGROUND
  • 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.

    PMID: 32336519BACKGROUND
  • 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.

    PMID: 23842982BACKGROUND
  • 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.

    PMID: 32324855BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Patient Satisfaction

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Karen Zaghiyan, MD

    Associate Professor of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 3, 2020

Study Start

September 28, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations