I-SCREEN: Increasing Screening for Cancer Using a Randomized Evaluation of EHR-based Nudges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,123
- 试验地点
- 4
- 主要终点
- Proportion of patients who complete a screening mammogram within 3 months after the visit
研究概览
简要总结
In this study, personalized nudges to clinicians and patients will be evaluated to help increase breast cancer screening rates in accordance with USPSTF guidelines among women with a primary care visit, with a particular emphasis on those at high risk for non-completion of cancer screening. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent, 6-month, cluster-randomized, pragmatic trials will be conducted. Those assigned to the intervention arm will receive the following clinician and patient level nudge interventions: clinicians will receive a default pended order for a mammogram in the visit encounter in the EHR (Penn and UH), and patients will receive post-visit text message reminders to encourage them to schedule their mammogram (Penn). Patients identified as high risk for noncompletion will be individually randomized to receive an additional bidirectional text message nudge or the standard text messaging (Penn).
详细描述
Cancer is a leading cause of mortality in the United States. While strong USPSTF guideline recommendations support appropriate screening for early detection and to avoid preventable deaths, breast cancer screening is often underutilized. Increasing breast cancer screening rates is challenging, in part, because it requires complementary decisions from clinicians (e.g., recommend and counsel patients about screening) and patients (e.g., to internalize risks and choose to complete screening). Presently, the lack of interventions directly targeting both clinicians' and patients' decision-making may underscore the relatively stagnant screening rates in the United States. There is a significant need to develop and scale low-cost interventions that increase breast cancer screening while simultaneously addressing the needs of high-risk patients and reducing disparities. Building upon prior work, the investigators propose to develop and test EHR-based clinician and patient nudges, with an additional intensified nudge to high-risk patients, to help increase screening mammography rates.
This study consists of two complementary and concurrent, cluster-randomized, pragmatic trials to be conducted at Penn and UH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- 否
入选标准
- •All patients must meet the following criteria to be eligible:
- •Women between 40 and 74 years of age
- •A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices (Penn Trial) or with one of the study primary care providers (UH Trial)
- •Are overdue and eligible for a mammogram per Health Maintenance
- •Does not have a future scheduled mammogram appointment
- •For the Penn Trial patient intensification nudge, at least one of the following criteria must be met to be considered high risk and randomized to receive the intensification nudge:
- •Medicare Insurance
- •Medicaid Insurance
- •No EHR patient portal account
- •Zero log-ins to EHR patient portal in the previous year
排除标准
- •Patients will be excluded from the study if:
- •History of bilateral mastectomy
- •Have a mammogram exclusion modifier in Health Maintenance
- •Have no phone number (home or mobile) listed in their chart (Penn Trial only)
研究组 & 干预措施
Penn: Control
Clinics randomized to the control arm will receive standard of care.
Penn: Intervention
Clinics randomized to the intervention arm will receive the toolkit of clinician and patient facing nudges. Patient nudges will be post-visit text message reminders (standard messaging content). Clinician nudges will be default pended orders.
干预措施: Post-visit patient text messaging (Behavioral)
Penn: Intervention
Clinics randomized to the intervention arm will receive the toolkit of clinician and patient facing nudges. Patient nudges will be post-visit text message reminders (standard messaging content). Clinician nudges will be default pended orders.
干预措施: Default pended order (Behavioral)
Penn: High Risk Intensification
Patients in the intervention clinics identified as high risk for noncompletion of mammogram will be randomized 1:1 to receive the high risk intensification arm or remain in the standard intervention arm. Patients in the high risk intensification arm will receive an additional bidirectional texting component.
干预措施: Post-visit patient text messaging (Behavioral)
Penn: High Risk Intensification
Patients in the intervention clinics identified as high risk for noncompletion of mammogram will be randomized 1:1 to receive the high risk intensification arm or remain in the standard intervention arm. Patients in the high risk intensification arm will receive an additional bidirectional texting component.
干预措施: Default pended order (Behavioral)
Penn: High Risk Intensification
Patients in the intervention clinics identified as high risk for noncompletion of mammogram will be randomized 1:1 to receive the high risk intensification arm or remain in the standard intervention arm. Patients in the high risk intensification arm will receive an additional bidirectional texting component.
干预措施: High risk bidirectional post-visit text messaging (Behavioral)
UH: Control
Primary care providers randomized to the control arm will receive standard of care.
UH: Intervention
Primary care providers randomized to the intervention arm will receive default pended orders for a mammogram.
干预措施: Default pended order (Behavioral)
结局指标
主要结局
Proportion of patients who complete a screening mammogram within 3 months after the visit
时间窗: 3 months
The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
Proportion of Patients Who Complete a Screening Mammogram Within 3 Months After the Visit
时间窗: 3 months
The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
次要结局
- Proportion of patients who complete a screening mammogram within 6 months after the visit(6 months)
- Proportion of Patients Who Complete a Screening Mammogram Within 6 Months After the Visit(6 months)
研究者
Amol Navathe
Professor of Health Policy and Medicine
Abramson Cancer Center at Penn Medicine