WashU DIEP Flap Video and Patient Understanding Improvement

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06864754
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • WashU DIEP Flap Video — OTHER
    Video uses visual cues and graphics to help explain complex procedures in a simplified, comprehensible fashion to patients.

Study Details

Patients will complete a survey before and after watching the WashU DIEP Flap Video at their pre-operative standard of care visit, and a third survey at their post-operative standard of care visit. These surveys will use questions from SILS, APAIS, PEMAT, and AIM/IAM to assess the patient's health literacy, demographics questions, and questions concerning patient understanding and anxiety surrounding the procedure. The purpose of the post-op survey will be to assess how well the video set expectations of the procedure and recovery process and will repeat questions asked pre-operatively. Survey responses will be analyzed to determine if there are beneficial trends and improvement in patient understanding and anxiety due to adjunct video usage. Primary Objective: The primary aim of the study is to determine if our animated video affects understanding and anxiety survey scores in patients undergoing DIEP breast reconstruction.

Key Dates

Start date
Jul 18, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: WashU DIEP Flap Video
    At the pre-operative appointment, patients will complete the pre-video survey (\~10min) via RedCap, watch the video (\~5min), and complete the post-video survey (\~10min) via RedCap. During the standard of care follow-up appointment ≤ 30 days after surgery, consented patients will fill out a third survey via RedCap (\~5min).

Primary Outcome Measure

Change in understanding as measured by the Comprehension Assessment [ Time Frame: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Justin M Sacks, M.D., MBA, FACS
[email protected]
314-362-7388
Justin M Sacks, M.D., MBA, FACS (PRINCIPAL_INVESTIGATOR)

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