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Clinical Trials/NCT04996316
NCT04996316
Enrolling By Invitation
Not Applicable

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

OHSU Knight Cancer Institute1 site in 1 country1,141 target enrollmentSeptember 7, 2022

Overview

Phase
Not Applicable
Intervention
Interview
Conditions
Breast Carcinoma
Sponsor
OHSU Knight Cancer Institute
Enrollment
1141
Locations
1
Primary Endpoint
Uptake of MammoScreen
Status
Enrolling By Invitation
Last Updated
2 months ago

Overview

Brief Summary

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

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 undergo training sessions of about 20 minutes, then participate in interviews lasting up to 30 minutes at baseline 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 maintenance phase about six months after the last reminders are sent. PATIENTS: Patients (enrolled from OHSU IMC) 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.

Registry
clinicaltrials.gov
Start Date
September 7, 2022
End Date
August 31, 2026
Last Updated
2 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Eden, Ph.D.

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

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

Arms & Interventions

Clinical staff (interview, training, survey)

Before implementation, some participants will complete usability testing of the interface in the electronic health record and MammoScreen. Participants undergo training sessions over 20 minutes and participate in interviews over 30 minutes at baseline, 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 maintenance phase, about six months after the last reminders are sent.

Intervention: Interview

Clinical staff (interview, training, survey)

Before implementation, some participants will complete usability testing of the interface in the electronic health record and MammoScreen. Participants undergo training sessions over 20 minutes and participate in interviews over 30 minutes at baseline, 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 maintenance phase, about six months after the last reminders are sent.

Intervention: Electronic Health Record Review

Clinical staff (interview, training, survey)

Before implementation, some participants will complete usability testing of the interface in the electronic health record and MammoScreen. Participants undergo training sessions over 20 minutes and participate in interviews over 30 minutes at baseline, 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 maintenance phase, about six months after the last reminders are sent.

Intervention: Survey Administration

Clinical staff (interview, training, survey)

Before implementation, some participants will complete usability testing of the interface in the electronic health record and MammoScreen. Participants undergo training sessions over 20 minutes and participate in interviews over 30 minutes at baseline, 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 maintenance phase, about six months after the last reminders are sent.

Intervention: Training and Education

Patients (interview, MammoScreen)

Patients participate in interviews up to 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.

Intervention: Electronic Health Record Review

Patients (interview, MammoScreen)

Patients participate in interviews up to 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.

Intervention: Interview

Patients (interview, MammoScreen)

Patients participate in interviews up to 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.

Intervention: Media Intervention

Outcomes

Primary Outcomes

Uptake of MammoScreen

Time Frame: Up to 5 years

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.

Number of women with above-average risk for breast cancer identified by MammoScreen integrated with the electronic health record

Time Frame: Up to 5 years

Secondary Outcomes

  • Screening completed(Up to 5 years)
  • Rates of mammography screening referral(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 received a genetic counseling referral(Up to 5 years)
  • Number of above average risk MammoScreen users who had a genetic test done(Up to 5 years)
  • Mammography results(Up to 5 years)

Study Sites (1)

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