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NCT Number: NCT06864754

WashU DIEP Flap Video and Patient Understanding Improvement

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Justin M Sacks, M.D., MBA, FACS

CONTACT

[email protected]

314-362-7388

Justin M Sacks, M.D., MBA, FACS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled to have DIEP-flap breast reconstruction at Barnes Jewish Hospital
  • Speak English
  • ≥ 18 years of age

Exclusion criteria

  • Non-English speaking are excluded as the consent, questionnaires, and video are only available in English.

Treatment and study plan

WashU DIEP Flap Video

Other

Video uses visual cues and graphics to help explain complex procedures in a simplified, comprehensible fashion to patients.

Primary outcomes

  1. 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)

    The pre-op, pre-video survey includes a 10-question comprehension assessment. The pre-op, post-video survey repeats the comprehension assessment. Scores of the comprehension assessment will be compared before and after video watching per patient to determine change in understanding due to the video. It will be scored on a 10-point scale based on correct answers with a higher score meaning greater understanding of the procedure.

  2. Change in anxiety as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Time frame: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)

    Scores of the APAIS will be compared before and after video watching per patient to determine change in anxiety due to the video. Scoring of APAIS will be per the literature (6-30 with higher score meaning greater anxiety).

Secondary outcomes

  1. Appropriate expectation setting as measured by The Patient Education Materials Assessment Tool (PEMAT)

    Time frame: Before video at pre-operative visit and at post-operative visit (estimated to be 3 months)

    Will be used to assess video quality. Validated scoring will be used (0-12 with higher score meaning better quality).

  2. Appropriate expectation setting as measured by the Acceptability of Intervention Measure (AIM)

    Time frame: At post-operative visit (estimated to be at 3 months)

    Validated survey which will be used per published scoring guidelines (8-40 with higher score meaning greater acceptability.

  3. Appropriate expectation setting as measured by the Intervention Appropriateness Measure (IAM)

    Time frame: At post-operative visit (estimated to be at 3 months)

    Validated survey which will be used per published scoring guidelines (8-40 with higher score meaning greater appropriateness.

Study contacts

Contact information is provided by the study sponsor or research team.

Justin M Sacks, M.D., MBA, FACS

CONTACT

[email protected]

314-362-7388

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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