EHR-Nudges for Breast Cancer Screening

(I-SCREEN Trial)

No longer recruiting at 1 trial location

Overseen By Amol Navathe, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Bilateral mastectomy, No phone number, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to boost breast cancer screening rates through personalized reminders. It aims to determine if reminders sent to both doctors and patients can encourage timely mammograms. Women with a scheduled primary care visit who are overdue for a mammogram might be suitable participants, particularly if they have not yet scheduled one. Those at higher risk of missing screenings, such as individuals with specific insurance types or those not using online health portals, may receive additional reminders. These reminders could include a default pended order or high-risk bidirectional post-visit text messaging. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies that could enhance breast cancer screening rates.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these nudges are safe for increasing breast cancer screening rates?

Research has shown that the treatments tested in this study have generally been well-tolerated in previous research.

For the "default pended order," studies have found that this method effectively increases breast cancer screening. It adds a reminder in electronic health records for doctors to order a mammogram during a visit. Previous findings suggest that both doctors and patients favor this approach, and no major safety concerns have been reported.

The "high-risk bidirectional post-visit text messaging" method uses text messages to remind patients to book their mammograms and allows them to reply and interact through texts. Past studies suggest this is a safe and effective way to encourage screenings, especially for those who might otherwise miss them.

Lastly, "post-visit patient text messaging" has significantly increased the number of people getting screened. This method simply sends a text reminder after a doctor’s visit. Research shows this approach is safe and well-accepted by patients, with no significant issues.

These strategies aim to improve communication and reminders, with evidence supporting their safety and effectiveness in encouraging more people to complete their cancer screenings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to boost breast cancer screening rates through innovative nudges. Traditional methods often rely on routine reminders, but this trial introduces three unique strategies: default pended orders for mammograms, standard post-visit text message nudges, and an intensified approach with bidirectional texting for patients at high risk of missing screenings. These methods aim to streamline communication and encourage timely screenings, potentially leading to earlier detection and better outcomes. By shifting from passive reminders to proactive engagement, this trial could redefine how healthcare providers encourage preventive care.

What evidence suggests that this trial's treatments could be effective for increasing breast cancer screening rates?

Research has shown that automatic reminders for mammograms can increase screening rates. In this trial, participants in the intervention arms will receive different types of reminders. One intervention arm will use default pended orders to help doctors remember to schedule mammograms, resulting in more patients getting screened. Another intervention arm will provide regular post-visit text message reminders, which have increased completed screenings by over two percent. For those identified as high risk, an additional intervention arm will include two-way text messages, offering extra reminders and encouragement. This method has shown promise in increasing screening completion. These reminders have encouraged hundreds more patients to get screened, proving effective in improving mammogram rates. ^{1 2 3 6 7}

Who Is on the Research Team?

Amol Navathe, MD, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for women aged 40-74 who are overdue for a mammogram, have an upcoming primary care visit but no future mammogram scheduled. High-risk patients include those with Medicare or Medicaid, or limited use of the EHR patient portal. Women with bilateral mastectomy or without a phone number listed in their chart cannot participate.

Inclusion Criteria

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

Exclusion Criteria

Have a mammogram exclusion modifier in Health Maintenance

I have had both of my breasts removed.

Have no phone number (home or mobile) listed in their chart (Penn Trial only)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinicians receive default pended orders for mammograms and patients receive post-visit text message reminders to encourage scheduling mammograms.

6 months

Ongoing visits as per primary care schedule

High Risk Intensification

High-risk patients receive an additional bidirectional texting component to encourage mammogram completion.

6 months

Follow-up

Participants are monitored for mammogram completion within 3 to 6 months after the first eligible primary care visit.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Default pended order
• High risk bidirectional post-visit text messaging
• Post-visit patient text messaging

Trial Overview The study tests if electronic health record (EHR) prompts and text message reminders can increase breast cancer screening rates. Clinicians get default orders to recommend mammograms, while patients receive texts reminding them to schedule one. High-risk individuals may also get extra bidirectional messaging.

How Is the Trial Designed?

Group I: UH: Intervention Experimental Treatment 1 Intervention

Primary care providers randomized to the intervention arm will receive default pended orders for a mammogram.

Group II: Penn: Intervention Experimental Treatment 2 Interventions

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.

Group III: Penn: High Risk Intensification Experimental Treatment 3 Interventions

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.

Group IV: UH: Control Active Control 1 Intervention

Primary care providers randomized to the control arm will receive standard of care.

Group V: Penn: Control Active Control 1 Intervention

Clinics randomized to the control arm will receive standard of care.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424003367?via%3Dihub

Increasing screening for breast cancer using a randomized ... In trial B, the clinician nudge intervention includes a default pended order for a screening mammogram (Fig. 2B). This order is pended by a member of the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11074930/

Behavioral Interventions to Improve Breast Cancer ... This report of 2 randomized clinical trials evaluates whether bulk ordering, text messaging, and clinician endorsement increase breast cancer screening rates.

3. pennmedicine.org pennmedicine.org/News/how-invitations-brought-mammogram-rates-up

'Invitations' from Penn Medicine restored mammogram rates A Penn Medicine team used text messages and default orders to bring more patients back to receiving routine mammograms after a pandemic pause.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10495926/

Automated Opt-Out vs Opt-In Patient Outreach Strategies ... This randomized clinical trial compares rates of adherence to recommended breast cancer screening when using an opt-out automatic referral strategy.

5. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-023-01308-w

Protocol to evaluate sequential electronic health record-based ... This pragmatic study will use a non-randomized, sequential adaptive design to examine the effect of patient- and clinician-directed nudges ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10935591/

Results from a national physician survey - PMC We found that many physicians would continue EMR reminders for cancer screening even in light of older age, limited life expectancy, and functional limitations.

7. ascopubs.org ascopubs.org/doi/10.1200/CCI.17.00090

Linking Reminders and Physician Breast Cancer ... Receiving reminders significantly increased the likelihood of physicians recommending mammography screening. In adjusted analyses, 84% (95% CI, ...