In Office Versus Telemedicine Preoperative Visit

Telemedicine Clinical Trial

Official title:

In Office Versus Telemedicine Preoperative Visit: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023175
• Other study ID #: 05-19-30E
• Status: Completed
• Phase: N/A
• Start date: July 27, 2019
• Est. completion date: February 2, 2021

Study information

• Verified date: June 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

PRIMARY OBJECTIVE 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.

SECONDARY OBJECTIVES

1. Evaluate patient satisfaction using the S-CAHPS survey

2. Calculate the duration of visit for patient (minutes)

3. Calculate the duration of visit for provider (minutes)

4. Estimate round trip travel distance from patient home to clinic (miles)

5. Evaluate the number of office contacts from date of preoperative counseling to 6 weeks postoperatively.

1. Patient initiated calls

2. Nurse initiated calls

3. Scheduled office visits

4. Add on office visits

6. Evaluate canceled, no-show, and late visits

7. Calculate value proposition metrics for Atrium Health System

PREOPERATIVE PERIOD All consecutive patients planning to undergo pelvic surgery who require a preoperative visit will be identified, screened, and approached for participation in the study. Participants who do not meet the inclusion and exclusion criteria will be considered screen failures. Screen failures will be captured and the cause for screen failure will be documented.

Verbal consent will be obtained and accurate email address will be confirmed. Eligible subjects will be randomized using a computer-generated randomization scheme with patients assigned in a 1:1 ratio to either:

Study Group: Telemedicine preoperative counseling with a Female Pelvic Medicine and Reconstructive Surgery (FPMRS) fellow

Control Group: Standard in-office preoperative counseling with a FPMRS fellow

The allocation sequence will be in numerical, sealed, opaque envelopes. An envelope will be retrieved at the time of consent. The surgical scheduler will then schedule the patient for their allocated preoperative visit.

Prior to their preoperative visit, participants in both groups will be emailed copies of the office Enhanced Recovery After Surgery informational booklet and International Urogynecology Association (IUGA) patient information handouts pertinent to their surgery. The preoperative visit at Women's Center for Pelvic Health (WCPH) is a counseling visit to review informed consent. Preoperative medical evaluation is accomplished through the Carolinas Hospitalist Group preoperative clinic or with the patient's primary care provider. Patients who require preoperative medical clearance will be scheduled for a preoperative visit with the Carolinas Hospitalist Group or their primary care provider in addition to their preoperative visit with the WCPH. These visits will be documented in the total office visit data collection.

Women in the Telemedicine group will check in for their preoperative visit via an Atrium Information Systems (IS) approved virtual communication platform at the scheduled date and time. They will undergo preoperative counseling following a standardized checklist format. After telemedicine counseling has concluded, participants will be emailed a REDCap survey link to complete a survey regarding their preparation for surgery. If a participant has not completed the survey by the next business day, an email reminder will be sent to their email address on file. If they have not completed the survey within 2 business days, they will be contacted by phone for reminder. If a participant in the Telemedicine group ultimately elects to have an in-office preoperative visit, they will be scheduled for in-office visit and analyzed as intention-to-treat.

Women in the In-office group will present to WCPH for preoperative in-person counseling following a standardized checklist format. After in-office counseling has concluded, participants will be asked to complete a survey regarding preparation for surgery via a REDCap survey link on an Atrium IS approved iPad prior to leaving the office.

PERIOPERATIVE PERIOD Participants will present to Mercy Hospital or One Day Surgery Center for their scheduled surgery. All participants will receive routine care according to the gynecologic enhanced recovery perioperative protocol. The gynecologic enhanced recovery perioperative protocol is a multimodal perioperative care pathway designed to achieve early recovery after surgery by maintaining preoperative organ function and reducing the physical stress of surgery on the body. This protocol includes many components including allowing patients to drink clear liquids up to 2 hours prior to their surgery, maintaining euvolemia intraoperatively, and early return to normal diet and activity after surgery. All patients undergoing pelvic reconstructive surgery are scheduled for the enhanced recovery protocol, except for women having only minor procedures such as mid-urethral sling placement or cystoscopy.

POSTOPERATIVE PERIOD All participants will undergo routine postoperative care. They will be scheduled for an in-office postoperative visit, on average 1-2 weeks after surgery and then again at 6 weeks after surgery per our office standard practice. Following their 2-week postoperative visit, women will be asked to complete the preoperative subsection of the Surgical-CAHPS survey to evaluate patient satisfaction. This will be given to all patients prior to leaving the office. If a patient does not present to their 2-week postoperative appointment, they will be mailed a paper copy of the preoperative subsection of the S-CAHPS and asked to return this via prepaid postage.

Following the 6 week postoperative visit, secondary data will then be extracted from the electronic medical record (EMR) via manual chart view.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 2, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Non-English speaking

• Inability to provide consent/decisionally impaired

• Auditory impairment

• Required preoperative in-office procedure such as endometrial biopsy

Related Conditions & MeSH terms

• Telemedicine

Intervention

Other:
• Telemedicine preoperative counseling
The telemedicine visit will be completed using an Atrium Health approved virtual visit platform.
• In office preoperative counseling
This includes our standard preoperative counseling located at the Women's Center for Pelvic Health

Locations

Country	Name	City	State
United States	Women's Center for Pelvic Health-Mercy	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (13)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Satisfaction	Patients will complete the preoperative portion of the Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS) at the 2-week postoperative visit. S-CAHPS is a validated standardized questionnaire for adults developed by the American College of Surgeons (ACS). There are various ways to score. We elected to measure total composite scores of the perioperative SCAHPS subsection ranging from 12 to 36, with greater scores equating to higher patient satisfaction. The minimum value is 0 and maximum is 33.	2 week postoperative visit
Secondary	Duration of Visit	Each visit will be timed to evaluate patient and provider visit duration. Timing will begin for the Telemedicine group upon connection to the virtual waiting room and will conclude after all counseling is completed and the virtual visit is disconnected. The duration of virtual visit counseling time with the provider will also be calculated. Timing for the in-office group will begin at time of patient check-in at the front desk and will conclude with patient check-out.	at preoperative visit (1-30 days prior to surgery)
Secondary	Round Trip Travel Distance	Round trip travel distance from patient's home address to office will be evaluated via a HIPPA compliant map-based search engine for each participant.	at preoperative visit (1-30 days prior to surgery)
Secondary	Office Contacts, Total Scheduled In-person Visits	The total number of scheduled in-person visits in the perioperative time period including preoperative and postoperative visits..	perioperative time period, up to approximately 10 weeks
Secondary	Postoperative Add on In-person Visits.	Clinical visits added in the six week postoperative time period.	6 weeks postoperatively
Secondary	Postoperative Patient Initiated Phone Calls.	Number of patient initiated postoperative telephone calls to the office in the six week postoperative time period.	6 weeks postoperatively
Secondary	Travel Time	Patient round-trip travel time in minutes from home to preoperative visits.	1 day of a preoperative visit.