跳至主要内容
临床试验/NCT04996316
NCT04996316Enrolling By Invitation不适用

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

OHSU Knight Cancer Institute1 个研究点 分布在 1 个国家目标入组 1,141 人开始时间: 2022年9月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,141
试验地点
1
主要终点
Uptake of MammoScreen

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
40 Years 至 74 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between the ages of 40 and 74
  • Enrolled in MyChart
  • Able to read English

排除标准

  • Personal history of breast or ovarian cancer
  • Currently Pregnant
  • Currently in Hospice

研究组 & 干预措施

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.

干预措施: Interview (Other)

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.

干预措施: Electronic Health Record Review (Other)

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.

干预措施: Survey Administration (Other)

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.

干预措施: Training and Education (Other)

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.

干预措施: Electronic Health Record Review (Other)

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.

干预措施: Interview (Other)

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.

干预措施: Media Intervention (Other)

结局指标

主要结局

Uptake of MammoScreen

时间窗: 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

时间窗: Up to 5 years

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Eden, Ph.D.

Principal Investigator

OHSU Knight Cancer Institute

研究点 (1)

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