Clinical trial NCT04472117: PREPARE: Patient Centered Perioperative Experience
Official title: PREPARE: Patient Centered Perioperative Experience
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Minimally Invasive Surgery (MIS) Hysterectomy
Keywords: Patient education
Perioperative setting
PREPARE
Patient centeREd PerioperAtive expeRiencE
20-287
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge
timeFrame: 2 years
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Elizabeth Jewell, MD
role: PRINCIPAL_INVESTIGATOR
References: