PREPARE: Patient Centered Perioperative Experience

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

Study Overview

• Status: Active, not recruiting
• Conditions: Minimally Invasive Surgery (MIS) Hysterectomy
• Intervention / Treatment: Other: usual care; Other: Educational video

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (All Protocol Activities)
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack (All Protocol Activities)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (All Protocol Activities)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Basking Ridge (All protocol activities)
    • Rockville Centre, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (All protocol activities)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Usual care and usual care plus video; Phase I (completed 3/31/2021): A sample of patients in phase I will complete a qualitative interview prior to or after surgery. Twenty-five evaluable patients (15 pre-operatively and a separate 10 post-operatively) will be selected to participate in an in-person/phone interview. Phase II: A separate group of women will compose phase II. All patients (N = 100) in phase II will complete discrete-choice surveys. Patients in phase III of the study will be randomized evenly to usual care plus video or usual care only. Phase III: One hundred participants will be randomized via CRDB to receive standard pre-operative counseling or standard pre-operative counseling with the additional of an educational video. Those randomized to view the video will also complete the post-video survey. All patients will complete the post-op survey.

Other: usual 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.; Other Names: Qualitative Interviews; Other: Educational 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	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.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Elizabeth Jewell, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Patient education; Perioperative setting; PREPARE; Patient centeREd PerioperAtive expeRiencE; 20-287
• Other Study ID Numbers: 20-287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No