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Implementing BREASTChoice Into Practice

NCT04491591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2024-08-12

Study results available
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Summary

Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many, there are numerous risks associated with the procedure. The risk of complications exceeds that of most elective procedures. In past work, a clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. It was modified with extensive stakeholder input and built to be incorporated into electronic health records and patient portals. This randomized control trial will evaluate whether the implementation of BREASTChoice into routine care delivery is more effective than a control website, at improving the quality of reconstruction decisions.

Conditions

Interventions

OTHER

Breast Reconstruction Education and Support Tool (BREASTChoice)

The tool is an interactive website and can be sent through My Chart and integrated into the electronic health record

OTHER

Attention Control Website

-(https://www.cancer.gov/types/breast/reconstruction-fact-sheet)

OTHER

Clinician Survey

-Questions regarding opinions on shared decision-making with answers ranging from 1-7 with 1=strongly disagree or harmful to 7=strongly agree or beneficial. The higher the score the more the physician agrees with shared decision making.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mary Politi, Ph.D. · Washington University School of Medicine

  • Clara Lee, M.D., MPP · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2022-07-22
Completion
2023-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04491591 on ClinicalTrials.gov