In Office Versus Telemedicine Preoperative Visit

NCT04023175 | Completed Results DMC

• 1 other identifier: 05-19-30E
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial evaluating in office versus telemedicine preoperative counseling visits based on patient preparedness for surgery and patient satisfaction.

Conditions

Telemedicine

Keywords

Virtual visit; Preoperative counseling; Preoperative preparedness

Outcome Measures

Primary Outcomes (1)

• Patient Preoperative Preparedness

  To determine whether preoperative telemedicine appointments are non-inferior to in-office visits based on patient preoperative preparedness in women undergoing pelvic surgery as measured by a preoperative preparedness survey. Preoperative Preparedness Questionnaire ranges from 11 to 66 points with higher scores equaling greater patient preparedness.

  1-7 days

Secondary Outcomes (7)

• Patient Satisfaction

  2 week postoperative visit

• Duration of Visit

  at preoperative visit (1-30 days prior to surgery)

• Round Trip Travel Distance

  at preoperative visit (1-30 days prior to surgery)

• Office Contacts, Total Scheduled In-person Visits

  perioperative time period, up to approximately 10 weeks

• Postoperative Add on In-person Visits.

  6 weeks postoperatively

Study Arms (2)

In office

ACTIVE COMPARATOR

Patients will undergo our standard in office preoperative counseling.

Other: In office preoperative counseling

Virtual visit

EXPERIMENTAL

Patients will undergo preoperative counseling using telemedicine virtual visits.

Other: Telemedicine preoperative counseling

Interventions

Telemedicine preoperative counseling OTHER

The telemedicine visit will be completed using an Atrium Health approved virtual visit platform.

Virtual visit

In office preoperative counseling OTHER

This includes our standard preoperative counseling located at the Women's Center for Pelvic Health

In office

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females age 18 and greater
• Visit location in North Carolina
• Planning to undergo pelvic surgery at Mercy Hospital or One Day Surgery Center
• Scheduled for enhanced recovery perioperative protocol
• Require a preoperative visit
• Access to internet and a virtual visit capable device
• Telephone access

You may not qualify if:

• Non-English speaking
• Inability to provide consent/decisionally impaired
• Auditory impairment
• Required preoperative in-office procedure such as endometrial biopsy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Women's Center for Pelvic Health-Mercy

Charlotte, North Carolina, 28215, United States

Location

Related Publications (13)

• Seidel JE, Beck CA, Pocobelli G, Lemaire JB, Bugar JM, Quan H, Ghali WA. Location of residence associated with the likelihood of patient visit to the preoperative assessment clinic. BMC Health Serv Res. 2006 Feb 22;6:13. doi: 10.1186/1472-6963-6-13.

  PMID: 16504058 BACKGROUND

• 2. Health Resources and Services Administration. (https://www.hrsa.gov/rural-health/telehealth/index.html) May 2019.

  BACKGROUND

• LaMonte MP, Bahouth MN, Hu P, Pathan MY, Yarbrough KL, Gunawardane R, Crarey P, Page W. Telemedicine for acute stroke: triumphs and pitfalls. Stroke. 2003 Mar;34(3):725-8. doi: 10.1161/01.STR.0000056945.36583.37. Epub 2003 Jan 30.

  PMID: 12624298 BACKGROUND

• Platts-Mills TF, Hendey GW, Ferguson B. Teleradiology interpretations of emergency department computed tomography scans. J Emerg Med. 2010 Feb;38(2):188-95. doi: 10.1016/j.jemermed.2008.01.015. Epub 2008 Sep 23.

  PMID: 18814996 BACKGROUND

• Asiri A, AlBishi S, AlMadani W, ElMetwally A, Househ M. The Use of Telemedicine in Surgical Care: a Systematic Review. Acta Inform Med. 2018 Oct;26(3):201-206. doi: 10.5455/aim.2018.26.201-206.

  PMID: 30515013 BACKGROUND

• Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.

  PMID: 23384334 BACKGROUND

• Lozada MJ, Nguyen JT, Abouleish A, Prough D, Przkora R. Patient preference for the pre-anesthesia evaluation: Telephone versus in-office assessment. J Clin Anesth. 2016 Jun;31:145-8. doi: 10.1016/j.jclinane.2015.12.040. Epub 2016 Apr 15.

  PMID: 27185698 BACKGROUND

• Nikolian VC, Williams AM, Jacobs BN, Kemp MT, Wilson JK, Mulholland MW, Alam HB. Pilot Study to Evaluate the Safety, Feasibility, and Financial Implications of a Postoperative Telemedicine Program. Ann Surg. 2018 Oct;268(4):700-707. doi: 10.1097/SLA.0000000000002931.

  PMID: 30095477 BACKGROUND

• Soegaard Ballester JM, Scott MF, Owei L, Neylan C, Hanson CW, Morris JB. Patient preference for time-saving telehealth postoperative visits after routine surgery in an urban setting. Surgery. 2018 Apr;163(4):672-679. doi: 10.1016/j.surg.2017.08.015. Epub 2018 Feb 3.

  PMID: 29398042 BACKGROUND

• Myers EM, Rustowicz L, Wells D, Kidd JB, Jannelli ML, Connolly A, Wu JM. Internet Use Among Urogynecology Patients in North Carolina. Female Pelvic Med Reconstr Surg. 2015 Sep-Oct;21(5):269-72. doi: 10.1097/SPV.0000000000000163.

  PMID: 25730431 BACKGROUND

• Mazloomdoost D, Kanter G, Chan RC, Deveaneau N, Wyman AM, Von Bargen EC, Chaudhry Z, Elshatanoufy S, Miranne JM, Chu CM, Pauls RN, Arya LA, Antosh DD. Social networking and Internet use among pelvic floor patients: a multicenter survey. Am J Obstet Gynecol. 2016 Nov;215(5):654.e1-654.e10. doi: 10.1016/j.ajog.2016.06.011. Epub 2016 Jun 16.

  PMID: 27319368 BACKGROUND

• Thompson, J MD et al. Outpatient visits versus telephone interviews for postoperative care: A randomized controlled trial (OPTIONS). [abstract] In: Proceedings of the 39th Annual Scientific Meeting of the American Urogynecologic Society; 2018 Oct 9-13; Chicago, IL Paper nr 1

  BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

Results Point of Contact

• Title: Dr. Elizabeth Braxton
• Organization: Atrium Health

egwbraxton@gmail.com

8032613377

Study Officials

• Elizabeth G Braxton, MD

  Novant Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 17, 2019
• Study Start: July 27, 2019
• Primary Completion: December 15, 2020
• Study Completion: February 2, 2021
• Last Updated: January 24, 2024
• Results First Posted: January 24, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)