Breast CancerI-SCREEN RepNCT06995703
Increasing Screening for Cancer Using EHR-Nudges Replication
A study testing Pre-Visit Patient Text Message, Post-Visit Patient Text Messages and Smart Data Element (SDE) in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pre-Visit Patient Text Message, Post-Visit Patient Text Messages and Smart Data Element (SDE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,490 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 at Lancaster General Health
- Are overdue and eligible for a mammogram per Epic Health Maintenance
- Does not have a future scheduled mammogram appointment
- Patients meeting at least one of the following criteria will be considered high risk for screening non-completion:
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- Medicare Insurance
- Medicaid Insurance
- No EHR patient portal account
- Zero log-ins to EHR patient portal in the previous year
Who cannot join
- Patients will be excluded from the study if they:
- Have a history of bilateral mastectomy, breast cancer, or metastatic cancer
- Have a mammogram exclusion modifier in Health Maintenance
- Have no phone number (home or mobile) listed in their chart
Trial locations and contacts
1 site in 1 country.
United States1 site
Lancaster General Health
Lancaster, Pennsylvania, 17602
About this study
Official title: Increasing Screening for Cancer Using EHR-Nudges, A Replication Trial
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. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent 6-month, cluster randomized, pragmatic trials were conducted from December 2023 to October 2024. This trial will now replicate those interventions at Lancaster General Health (LGH), incorporating learnings from the primary trials while also adapting to align with existing health system protocols and policies. The patient nudge interventions include pre- and post-visit text message reminders to encourage the patient to schedule their mammogram, and the clinician nudge intervention includes a Smart Data Element message in the electronic health record (EHR) reminding the care team that the patient is overdue and that patients are more likely to complete their screening if recommended and ordered by their clinician.
Read the detailed description
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 at a replication site (Lancaster General Health) to help increase screening mammography rates. The analyses will compare the effectiveness of clinician and patient nudges in the overall patient population and separately among high-risk patients to inform what methods are most effective for each of these populations.
- Conditions
- Breast Cancer
- Being tested
- Pre-Visit Patient Text Message, Post-Visit Patient Text Messages, Smart Data Element (SDE)
- Keywords
- Screening, Mammogram, Behavioral Economics, Prevention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Visit Patient Text MessageBehavioural
Patients will be sent a text message reminder 1 day prior to their scheduled primary care visit. This message will remind them of their upcoming appointment, highlight that they may be overdue for their mammogram, and encourage them to speak with their provider or schedule now by using the provided online scheduling link or phone number. Patients who do not have a cell phone number listed in the EHR will receive automated voice recording (AVR).
Post-Visit Patient Text MessagesBehavioural
Patients will be sent text message reminders 4 days and 14 days after their completed primary care visit if they have not yet scheduled or completed their screening mammogram. The message delivered at 4 days post-visit will remind the patient to schedule and that appointments are available for them. The message delivered at 14-days post-visit will again encourage the patient to schedule their mammogram, if one has not already been scheduled or completed. Both messages will include a scheduling phone number and link to self-schedule online. Patients who do not have a cell phone number listed in the EHR will receive automated voice recording (AVR).
Smart Data Element (SDE)Behavioural
The clinician-facing Smart Data Element (SDE) in the EHR will be visible to the provider and care team during the visit encounter. The SDE will display as a section in pre-charting, check-in, and rooming and will notify the clinician and care team that a pre-visit communication was sent to the patient regarding scheduling an overdue mammogram and including results from prior work that show that patients are more likely to complete their screening if they receive an order and recommendation from their provider.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Visit Text Message/Smart Data Element Only | Experimental | Patients randomized to this arm will receive the pre-visit text message and Smart Data Element nudges. Receives: Behavioral: Pre-Visit Patient Text Message; Behavioral: Smart Data Element (SDE) |
| Pre-Visit Text Message/Smart Data Element + Post-Visit Text Message | Experimental | Patients randomized to this arm will be eligible to receive both the pre- and post-visit text messages and the Smart Data Element nudges. Receives: Behavioral: Pre-Visit Patient Text Message; Behavioral: Post-Visit Patient Text Messages; Behavioral: Smart Data Element (SDE) |
| Post-Visit Text Message Only | Experimental | Patients randomized to this arm will be eligible to receive the post-visit text message nudges. Receives: Behavioral: Post-Visit Patient Text Messages |
| Standard of Care | No intervention | Patients randomized to the standard of care arm will receive no nudge interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who complete a screening mammogram within 3 months after the visit
The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
Measured: 3 months
Secondary outcomes (1)
Proportion of patients who complete a screening mammogram within 6 months after the visit
The secondary outcome is screening mammogram completion within 6 months after the first eligible primary care visit.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start2 Jun 2025
- Primary completion2 Mar 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- In a 2x2 factorial design, eligible patients will be randomized in a 1:1 ratio on two factors: 1) receive a pre-visit text message (patient nudge) and Smart Data Element (SDE) message in the EHR (clinician nudge) or no pre-visit text and SDE message; and 2) receive post-visit text messaging or no post-visit text messaging.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 8,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Amol Navathe, Abramson Cancer Center at Penn Medicine
- Investigators
- Amol Navathe, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995703
- Sponsor's protocol ID
- UPCC 03025
- Other IDs
- R33AG068947
- Acronym
- I-SCREEN Rep
- Status last verified
- Aug 2026
- First submitted
- 21 May 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Screening for Cancer Using EHR-Nudges, A Replication Trial
- ClinicalTrials.gov ID
- NCT06995703
- Acronym / sponsor ID
- I-SCREEN Rep / UPCC 03025
- Conditions
- Breast Cancer
- Keywords
- Screening, Mammogram, Behavioral Economics, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,490 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent 6-month, cluster randomized, pragmatic trials were conducted from December 2023 to October 2024. This trial will now replicate those interventions at Lancaster General Health (LGH), incorporating learnings from the primary trials while also adapting to align with existing health system protocols and policies. The patient nudge interventions include pre- and post-visit text message reminders to encourage the patient to schedule their mammogram, and the clinician nudge intervention includes a Smart Data Element message in the electronic health record (EHR) reminding the care team that the patient is overdue and that patients are more likely to complete their screening if recommended and ordered by their clinician.
Detailed description
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 at a replication site (Lancaster General Health) to help increase screening mammography rates. The analyses will compare the effectiveness of clinician and patient nudges in the overall patient population and separately among high-risk patients to inform what methods are most effective for each of these populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- In a 2x2 factorial design, eligible patients will be randomized in a 1:1 ratio on two factors: 1) receive a pre-visit text message (patient nudge) and Smart Data Element (SDE) message in the EHR (clinician nudge) or no pre-visit text and SDE message; and 2) receive post-visit text messaging or no post-visit text messaging.
| Arm | Type | Receives |
|---|---|---|
| Pre-Visit Text Message/Smart Data Element Only | Experimental | Behavioral: Pre-Visit Patient Text Message, Behavioral: Smart Data Element (SDE)Patients randomized to this arm will receive the pre-visit text message and Smart Data Element nudges. |
| Pre-Visit Text Message/Smart Data Element + Post-Visit Text Message | Experimental | Behavioral: Pre-Visit Patient Text Message, Behavioral: Post-Visit Patient Text Messages, Behavioral: Smart Data Element (SDE)Patients randomized to this arm will be eligible to receive both the pre- and post-visit text messages and the Smart Data Element nudges. |
| Post-Visit Text Message Only | Experimental | Behavioral: Post-Visit Patient Text MessagesPatients randomized to this arm will be eligible to receive the post-visit text message nudges. |
| Standard of Care | No intervention | –Patients randomized to the standard of care arm will receive no nudge interventions. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 at Lancaster General Health
- Are overdue and eligible for a mammogram per Epic Health Maintenance
- Does not have a future scheduled mammogram appointment
- Patients meeting at least one of the following criteria will be considered high risk for screening non-completion:
Key exclusion criteria (4 listed)
- Have a history of bilateral mastectomy, breast cancer, or metastatic cancer
- Have a mammogram exclusion modifier in Health Maintenance
- Have no phone number (home or mobile) listed in their chart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Visit Patient Text MessagePatients will be sent a text message reminder 1 day prior to their scheduled primary care visit. This message will remind them of their upcoming appointment, highlight that they may be overdue for their mammogram, and encourage them to speak with their provider or schedule now by using the provided online scheduling link or phone number. Patients who do not have a cell phone number listed in the EHR will receive automated voice recording (AVR). | Behavioural | Pre-Visit Text Message/Smart Data Element + Post-Visit Text Message, Pre-Visit Text Message/Smart Data Element Only |
| Post-Visit Patient Text MessagesPatients will be sent text message reminders 4 days and 14 days after their completed primary care visit if they have not yet scheduled or completed their screening mammogram. The message delivered at 4 days post-visit will remind the patient to schedule and that appointments are available for them. The message delivered at 14-days post-visit will again encourage the patient to schedule their mammogram, if one has not already been scheduled or completed. Both messages will include a scheduling phone number and link to self-schedule online. Patients who do not have a cell phone number listed in the EHR will receive automated voice recording (AVR). | Behavioural | Post-Visit Text Message Only, Pre-Visit Text Message/Smart Data Element + Post-Visit Text Message |
| Smart Data Element (SDE)The clinician-facing Smart Data Element (SDE) in the EHR will be visible to the provider and care team during the visit encounter. The SDE will display as a section in pre-charting, check-in, and rooming and will notify the clinician and care team that a pre-visit communication was sent to the patient regarding scheduling an overdue mammogram and including results from prior work that show that patients are more likely to complete their screening if they receive an order and recommendation from their provider. | Behavioural | Pre-Visit Text Message/Smart Data Element + Post-Visit Text Message, Pre-Visit Text Message/Smart Data Element Only |
Primary outcome
Proportion of patients who complete a screening mammogram within 3 months after the visit
Time frame: 3 months
The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
1 secondary outcome
Proportion of patients who complete a screening mammogram within 6 months after the visit
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol Navathe, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Visit Patient Text Message, Post-Visit Patient Text Messages and Smart Data Element (SDE) in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who complete a screening mammogram within 3 months after the visit (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.