Clinical trial NCT04023175: In Office Versus Telemedicine Preoperative Visit
Official title: In Office Versus Telemedicine Preoperative Visit: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Keywords: Virtual visit
Preoperative counseling
Preoperative preparedness
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

   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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Preoperative Preparedness
timeFrame: 1-7 days
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 2 week postoperative visit
measure: Duration of Visit
timeFrame: at preoperative visit (1-30 days prior to surgery)
measure: Round Trip Travel Distance
timeFrame: at preoperative visit (1-30 days prior to surgery)
measure: Office Contacts, Total Scheduled In-person Visits
timeFrame: perioperative time period, up to approximately 10 weeks
measure: Postoperative Add on In-person Visits.
timeFrame: 6 weeks postoperatively
measure: Postoperative Patient Initiated Phone Calls.
timeFrame: 6 weeks postoperatively
measure: Travel Time
timeFrame: 1 day of a preoperative visit.
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Women's Center for Pelvic Health-Mercy
state: North Carolina
Study officials:
affiliation: Novant Health
name: Elizabeth G Braxton, MD
role: PRINCIPAL_INVESTIGATOR
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