Minimally Invasive Surgery (MIS) Hysterectomy
Conditions
Keywords
Patient education, Perioperative setting, PREPARE, Patient centeREd PerioperAtive expeRiencE, 20-287
Brief summary
The purpose of this study is to determine whether an educational video about patients' perioperative experience (period that spans from the time of admission to the hospital to the time of recovery after surgery) will affect the timing of hospital discharge. The researchers will use information collected during this study to create a questionnaire and an educational video related to the patient perioperative experience. The educational video will address patient concerns about the perioperative period and recovery after surgery (post-operative recovery). All participants in this study will be undergoing a MIS hysterectomy according to their routine care in the Gynecology
Interventions
OTHERusual care
Interviews will be conducted in person or by telephone by an MD on the research team who does not have an ongoing treatment relationship with the patient, and has been trained by the qualitative methods specialist. Interviews will take place over the phone or in person and are anticipated to last approximately 20-30 minutes.
OTHEREducational video
Watch an educational video created by the research team and.will also complete the post-video survey. Those randomized to view the video must complete the post-video survey (Appendix 3), and all patients must complete the Post-Op Survey with the Patient Experience and Decision Regret Scale (Appendix 5) to be evaluable. If not completed, they will be replaced.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
There will be three phases in this study. Phase I will comprise 25 evaluable women (15 pre-operatively and a separate 10 post-operatively). The results of the pre-operative interviews will be closely monitored for data saturation and we may stop accrual earlier than the planned 15. Phase II will comprise 100 evaluable women. Phase III will comprise 100 evaluable women. All patients will undergo standard-of-care MIS hysterectomy, with standard follow-up with the addition of the interventions and randomization takes place here. Phase III participants will be deemed evaluable if they complete required surveys and if their charts contain sufficient information to determine their day-surgery status.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Woman ≥18 years of age. * Scheduled to undergo MIS hysterectomy by a gynecologic oncologist at MSK at either Josie Robertston Surgery Center or the main hospital OR completed MIS hysterectomy by a gynecologic oncologist at MSK at either Josie Robertson Surgery Center or the main hospital within 1 month of consent (post-op patients eligible for Phase 1 only). Phase 1 was completed on 3/31/2021). * Determined to be an appropriate candidate for the AXR program or expected to be discharged within 23 hours after surgery.
Exclusion criteria
* Not able to speak and read English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 2 years | Data from the discrete-choice experiment will be used to summarize patients' preferences and priorities. The discrete-choice experiment will entail a series of 28 side-by-side comparisons of hypothetical scenarios. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth Jewell, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed