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TelemedicineNCT04023175

In Office Versus Telemedicine Preoperative Visit

A study testing Telemedicine preoperative counseling and In office preoperative counseling in people with Telemedicine, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Telemedicine
What is being tested?
Telemedicine preoperative counseling and In office preoperative counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteUnited States
Study dates
27 Jul 2019to 2 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Women's Center for Pelvic Health-Mercy

    Charlotte, North Carolina, 28215

Other trials in United States

About this study

Official title: In Office Versus Telemedicine Preoperative Visit: a Randomized Controlled Trial

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

Read the detailed 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.
  6. Patient initiated calls
  7. Nurse initiated calls
  8. Scheduled office visits
  9. Add on office visits
  10. Evaluate canceled, no-show, and late visits
  11. 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.

Conditions
Telemedicine
Being tested
Telemedicine preoperative counseling, In office preoperative counseling
Keywords
Virtual visit, Preoperative counseling, Preoperative preparedness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine preoperative counselingOther

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

  • In office preoperative counselingOther

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

Study groups in NCT04023175
Study groupRoleWhat they receive
In officeActive comparatorPatients will undergo our standard in office preoperative counseling.
Receives: Other: In office preoperative counseling
Virtual visitExperimentalPatients will undergo preoperative counseling using telemedicine virtual visits.
Receives: Other: Telemedicine preoperative counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1-7 days

Secondary outcomes (7)
  1. 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.

    Measured: 2 week postoperative visit

  2. 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.

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

  3. 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.

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

  4. 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..

    Measured: perioperative time period, up to approximately 10 weeks

  5. Postoperative Add on In-person Visits.

    Clinical visits added in the six week postoperative time period.

    Measured: 6 weeks postoperatively

  6. Postoperative Patient Initiated Phone Calls.

    Number of patient initiated postoperative telephone calls to the office in the six week postoperative time period.

    Measured: 6 weeks postoperatively

  7. Travel Time

    Patient round-trip travel time in minutes from home to preoperative visits.

    Measured: 1 day of a preoperative visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2019
  2. Study start27 Jul 2019
  3. Primary completion15 Dec 2020
  4. Study completion2 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04023175
Sponsor's protocol ID
05-19-30E
Status last verified
Jun 2021
First submitted
10 Jul 2019
Last updated
24 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16504058
  • 2. Health Resources and Services Administration. (https://www.hrsa.gov/rural-health/telehealth/index.html) May 2019.

  • 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.

    PubMed 12624298
  • 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.

    PubMed 18814996
  • 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.

    PubMed 30515013
  • 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.

    PubMed 23384334
  • 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.

    PubMed 27185698
  • 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.

    PubMed 30095477
  • 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.

    PubMed 29398042
  • 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.

    PubMed 25730431
  • 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.

    PubMed 27319368
  • 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

  • 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.

    PubMed 18929686

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine preoperative counseling and In office preoperative counseling in people with Telemedicine, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Preoperative Preparedness (time frame: 1-7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04023175, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.

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