Pelvic Organ Prolapse
Conditions
Brief summary
Postoperative follow up is necessary following any surgical procedure and has been conducted in the same manner since the field of surgery began. The study will determine feasibility and patient satisfaction of innovative postoperative virtual clinical encounters utilizing mobile video conference technology for women undergoing pelvic reconstructive surgery through a randomized controlled trial.
Detailed description
This will be a prospective randomized control study comparing postoperative virtual clinical encounters versus traditional in-office postoperative visits in women undergoing pelvic reconstructive surgery. The postoperative experiences of both groups will be assessed via surveys. Virtual Clinical Encounter Group: - Receive video-conference call from office nurse 48-72 hours post discharge from hospital - Receive video-conference call from fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit Traditional Office Group: - Receive telephone call from office nurse 48-72 hours post discharge from hospital - Have in-office postoperative visit with fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit
Interventions
OTHERVCE
Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.
OTHERSurvey
Measure of satisfaction regarding post-op visit.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing surgery for pelvic organ prolapse * Age greater than 18 * Access to a smartphone * Access to high speed internet access (via 4G or 3G on their smartphone or high speed Wi-Fi) * Signed up for MyPennMedicine web portal * Ability to download MyChart mobile application * Pennsylvania Hospital Subject: NJ or PA resident, HUP & Presbyterian Hospital Subject: PA resident
Exclusion criteria
* Pregnancy * Inability to read, speak or understand English * Isolated midurethral sling procedure * Extraperitoneal vaginal colpopexy with Uphold mesh
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Via the Patient Satisfaction Questionnaire -18 | 30 days | PSQ-18 is a validated eighteen item patient satisfaction questionnaire that has been utilized across diverse healthcare settings. It measures satisfaction across the following domains: general satisfaction, technical quality of care, interpersonal manner of healthcare provider, communication, financial aspects of care, time spent with healthcare provider and accessibility/convenience of care. Total scores range from 18 to 90, with higher scores indicating higher patient satisfaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Post-op VCE As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The VCE group will conduct their encounter via the videoconference section of the MyChart mobile applications. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.
VCE: Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.
Survey: Measure of satisfaction regarding post-op visit. | 26 |
| Office Post-operative Visits As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The traditional follow up group will receive a telephone call from the office nurse as is current standard of care. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.
Survey: Measure of satisfaction regarding post-op visit. | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject cancelled surgery | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Office Post-operative Visits | Total | Post-op VCE |
|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 11.3 | 58.9 years STANDARD_DEVIATION 11.1 | 59.9 years STANDARD_DEVIATION 10.9 |
| Race/Ethnicity, Customized Black | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 23 Participants | 44 Participants | 21 Participants |
| Sex: Female, Male Female | 26 Participants | 52 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Patient Satisfaction Via the Patient Satisfaction Questionnaire -18
PSQ-18 is a validated eighteen item patient satisfaction questionnaire that has been utilized across diverse healthcare settings. It measures satisfaction across the following domains: general satisfaction, technical quality of care, interpersonal manner of healthcare provider, communication, financial aspects of care, time spent with healthcare provider and accessibility/convenience of care. Total scores range from 18 to 90, with higher scores indicating higher patient satisfaction.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-op VCE | Patient Satisfaction Via the Patient Satisfaction Questionnaire -18 | 80.7 score on a scale | Standard Deviation 2.6 |
| Office Post-operative Visits | Patient Satisfaction Via the Patient Satisfaction Questionnaire -18 | 81.2 score on a scale | Standard Deviation 2.8 |
95% CI: [-1.95, 1.03]