PREPARE: Patient Centered Perioperative Experience

NCT04472117 | Active Not Recruiting

• 1 other identifier: 20-287
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

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

Conditions

Minimally Invasive Surgery (MIS) Hysterectomy

Keywords

Patient education; Perioperative setting; PREPARE; Patient centeREd PerioperAtive expeRiencE; 20-287

Outcome Measures

Primary Outcomes (1)

• Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge

  2 years

Secondary Outcomes (1)

• Patient satisfaction

  2 years

Study Arms (1)

Usual care and usual care plus video

EXPERIMENTAL

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; Other: Educational video

Interventions

usual care OTHER

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.

Also known as: Qualitative Interviews

Usual care and usual care plus video

Educational video OTHER

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.

Usual care and usual care plus video

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Woman undergoing MIS hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not able to speak and read English.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (All Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (All Protocol Activities)

Rockville Centre, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Elizabeth Jewell, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: July 9, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (7)