MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals

Study Overview
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Brief Summary
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This study collects information to implement MammoScreen for Breast Cancer Screening and Referrals. MammoScreen is a risk assessment questionnaire that identifies individuals at average and increased risk for breast cancer and guides their screening decisions.

Detailed Description
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PRIMARY OBJECTIVES: I. Uptake of MammoScreen (the proportion of women who enroll and use MammoScreen, also referred to as Reach. II. Identification of women with above-average risk for breast cancer by MammoScreen integrated with the electronic health record (EHR). SECONDARY OUTCOMES: I. Rates of mammography screening referral. II. Screening completed and mammography results stratified by risk category. III. Among those who meet criteria, genetic counseling referral, visit completed and genetic test done. OUTLINE: CLINICAL STAFF: During development some clinical team members will participate in usability testing (up to 30 minutes) of the electronic health record interface with MammoScreen. Some participants will participate in interviews lasting up to 30 minutes at baseline, then undergo training sessions of about 20 minutes monthly prior to MammoScreen launch. Clinical staff also participate in interviews up to 30 minutes after MammoScreen launch during years 2-4. Participants complete surveys during the first month of the maintenance phase. PATIENTS: Patients participate in interviews lasting up to 1 hour. Patients medical records are reviewed. Patients will be invited via MyChart to use the MammoScreen. Reminders will be sent via MyChart to non-respondents at 2 and 4 weeks. Patients will use MammoScreen one time right after enrollment. Some patients may also participate in interviews up to 1 hour each during years 3-5.

Official Title
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Implementing USPSTF Recommendations for Breast Cancer Screening and Prevention by Integrating Clinical Decision Support Tools With the Electronic Health Record

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Other: Electronic Health Record Review
* Other: Interview
* Other: Media Intervention
* Other: Survey Administration
* Other: Training and Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the ages of 40 and 74 Enrolled in MyChart Able to read English Exclusion Criteria: Personal history of breast or ovarian cancer Currently Pregnant Currently in Hospice

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical staff (interview, training, survey)<br>Before implementation, some participants will complete usability testing of the interface in the electronic health record and MammoScreen. Participants participate in interviews over 30 minutes at baseline, then undergo training sessions over 20 minutes monthly prior to MammoScreen launch. Clinical staff also participate in interviews over 30 minutes after MammoScreen launch during years 2-4. Participants complete surveys during the first month of the maintenance phase. | Other: Electronic Health Record Review<br>* Health record reviewed<br>Other: Interview<br>* Participate in interview<br>Other: Survey Administration<br>* Complete survey<br>Other: Training and Education<br>* Undergo training<br>|
| Patients (interview, MammoScreen)<br>Patients participate in interviews over 1 hour. Patients medical records are reviewed. Patients use the MammoScreen at enrollment. Some Patients will also participate in interviews up to 1 hour, each during years 3-5. | Other: Electronic Health Record Review<br>* Health record reviewed<br>Other: Interview<br>* Participate in interview<br>Other: Media Intervention<br>* Use MammoScreen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of MammoScreen | Defined as the proportion of women who enroll and use MammoScreen. Proportions of invitations for newly eligible women and uptake of MammoScreen during the maintenance period, overall and by clinical team, will be characterized along with 95% exact confidence intervals. | Up to 5 years | 
| Number of women with above-average risk for breast cancer identified by MammoScreen integrated with the electronic health record (EHR) |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of mammography screening referral |  | Up to 5 years | 
| Screening completed | The proportions of patients who open, and complete MammoScreen and 95% confidence intervals will be calculated. Demographic and clinical characteristics of patients who complete MammoScreen versus those who do not will be compared using a two-sample t-test or chi-square test as appropriate. Variation in completing MammoScreen by patient (e.g., age) and provider characteristics (e.g., panel size) will be explored. | Up to 5 years | 
| Mammography results | Will be stratified by risk category. Will be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data. | Up to 5 years | 
| Number of above average risk MammoScreen users who received a genetic counseling referral | Will be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data. | Up to 5 years | 
| Number of above average risk MammoScreen users who completed a genetic counseling visit |  | Up to 5 years | 
| Number of above average risk MammoScreen users who had a genetic test done |  | Up to 5 years |