Clinical trial NCT04491591: Implementing BREASTChoice Into Practice
Official title: Implementing Breast Reconstruction Clinical Decision Support in Diverse Practice Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Reconstruction
Breast Cancer
Keywords: Breast cancer
Breast Reconstruction
Breast Reconstruction Education
Breast Reconstruction Decision Tool
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-07-29
Enrollment: 396
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Prior to the beginning of the Randomized Control Trial (RCT), a pilot phase will be launched to test the workflow and procedures. The investigators plan to recruit up to 20 patients, continuing until procedures are smooth and ready for the randomized trial. The investigators will follow these same procedures as the trial, other than randomization, to test the workflow and tool use programming.

For the RCT, patients considering mastectomy at academic and community practices (n=340) will be randomized over 18 months to use BREASTChoice or a control website.

After the patient participant consents to be in the study, they will be randomized (using computer random assignment) participants to view the clinical decision support tool, BREASTChoice or the attention control website, using block randomization (block size of 2 and 4). Depending on the clinic work-flow, the patients may be sent the link to the tool or control website: 1) by email or MyChart message, prior to their visit with the plastic or reconstruction surgeon, for them to complete from home or in the waiting room (ideal and preferred approach); 2) by email or MyChart, in person or virtually at the time of their plastic or reconstruction visit, for patients that have same-day breast surgeon and plastic reconstruction surgeon visits, with time to wait in between appointments; or 3) by email or MyChart, after the plastic surgery appointment, if they have not yet made a decision about reconstruction after mastectomy (e.g., if they are undergoing neoadjuvant chemotherapy, or they want or need more time to decide on their surgery choices). Participants will be sent the link via MyChart unless they do not have a MyChart account. In that case, they will be sent the link via email. Study staff will be available to answer questions about MyChart via phone or email.

BREASTChoice is interactive with multiple modules. It starts with facts about breast reconstruction. Modules describe pros and cons of reconstruction, reconstruction timing, and reconstruction types. When discussing reconstruction timing, a risk prediction model pulls health data from the EHR (asking patients information in the model that is missing) to personalize risk of complications from immediate breast reconstruction. It also shows average risks for mastectomy alone and mastectomy plus immediate breast reconstruction so women can compare their personalized risk to average risks. Each module contains real patient quotes, a section called "Let's review" which checks patients' understanding, and "What matters to you", which elicits patients' preferences. Diverse patient photos and outcomes are provided. It is written at a 7th grade reading level. Data on patients' risks and a summary of her preferences are sent to their plastic/reconstructive surgeon to view in the electronic health record. The tool takes the patient about 20minutes to complete.

Control Website: The investigators chose an attention control, rather than usual care, to reduce differences between arms in participant expectation of benefit. Those in the control arm will get a link to an NCI website about breast reconstruction. That website includes 10 sections with information about types of breast reconstruction, timing, recovery, risks, cancer surveillance and additional resources. The website provides information, but does not include values clarification or tailored risk information. It is not interactive and does not include photos..

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

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosis of incident or recurrent stage 0-III breast carcinoma

Exclusion Criteria:

* Stage IV breast carcinoma
* Histology type besides ductal/lobular carcinoma (e.g. phyllodes, sarcoma - these rare tumors differ in treatment and prognosis)
* Prior mastectomy and are seeking delayed breast reconstruction
* No malignancy (i.e., considering mastectomy for prophylaxis only)
* Cannot give informed consent or use provided study materials due to self-reported or observed cognitive, visual, or emotional barriers

Inclusion Criteria for Clinicians:

-Clinicians who provide breast cancer care within the plastic and reconstructive surgery at Barnes Jewish Hospital, Siteman Cancer Center, Barnes Jewish West County, Christian Hospital North East, and the Stefanie Spielman Comprehensive Breast Center of OSU who provide care for patients considering breast reconstruction after mastectomy

Exclusion Criteria for Clinicians:

-Plastic and reconstructive clinicians working at other breast clinic locations, and surgeons who do provider breast reconstruction care to patients who have undergone a mastectomy due to breast cancer

Primary outcomes:
measure: Knowledge as Measured by Decision Quality Instrument
timeFrame: After initial visit but before surgery, estimated to be before day 7
measure: Preference Concordance
timeFrame: Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR
measure: Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict
timeFrame: After initial visit but before surgery, estimated to be before day 7
Secondary outcomes:
measure: Compare Number of High-risk Participants From Each Arm Who Chose Breast Reconstruction
timeFrame: After patient participation (approximately 18 months)
measure: Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale
timeFrame: Assessed pre- and post-study (approximately 24 months)
measure: Knowledge as Measured by Knowledge Questions Developed in Previous Studies
timeFrame: After initial visit but before surgery, estimated before day 7
measure: Consult Time as Measured by Time Spent With Clinician During the Visit
timeFrame: Initial visit (day 1)
measure: Usability as Measured by the System Usability Scale (SUS)
timeFrame: After initial visit but before surgery, estimated to be before day 7
measure: Knowledge as Measured by Decision Quality Instrument
timeFrame: After initial visit but before surgery, estimated to be before day 7
measure: Preference Concordance as Measured by the Decision Quality Instrument
timeFrame: Preference assessed after initial visit, estimated to be day 7; actual treatment received collected from the EHR
measure: Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict
timeFrame: After initial visit but before surgery, estimated to be before day 7
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Washington University School of Medicine
name: Mary Politi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Clara Lee, M.D., MPP
role: PRINCIPAL_INVESTIGATOR
References: