Breast Cancer
Conditions
Keywords
Screening, Mammogram, Behavioral Economics, Prevention
Brief 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, 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).
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, 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.
Interventions
BEHAVIORALPost-visit patient text messaging
Patients will be sent text message reminders 4 days and 14 days after their primary care visit. The message delivered 4-days post-visit will remind the patient that a screening mammogram was recently ordered by their doctor, that appointments have been reserved for them, and to pre-commit to scheduling. The message delivered at 14-days post-visit will remind the patient of their recent screening mammogram order and encourage them to schedule their appointment, if one has not already been scheduled.
BEHAVIORALDefault pended order
A default pended order for a mammogram will be pended to the patient's upcoming primary care encounter and will be visible to the provider during the visit encounter. Clinical staff will have the option of signing the order or dismissing it if they deem it inappropriate for a given patient.
BEHAVIORALHigh risk bidirectional post-visit text messaging
High risk patients randomized to receive the high risk intensification nudge will receive a bidirectional text messaging component after their visit. This intervention will query the patient about common questions or concerns about breast cancer screening. The bi-directional text messaging intervention will provide additional educational materials based on patient response as well as information about resources to help navigate to screening.
Sponsors
Abramson Cancer Center at Penn Medicine
National Institute on Aging (NIA)
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
For the Penn trial, primary care clinics will be randomized 2:1 to the intervention arm or control arm using covariate-constrained randomization. Patients identified as at high-risk for non-completion of breast cancer screening will be additionally randomized 1:1 at the individual level to receive an additional intensification nudge compared with the multi-component nudge intervention alone. Penn Medicine is expected to enroll approximately 15,000 patients. For the UH trial, primary care providers will be randomized 1:1 to the intervention or control arm using covariate-constrained randomization. UH is expected to enroll approximately 6,416 patients.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
All patients must meet the following criteria to be eligible: 1. Women between 40 and 74 years of age 2. 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) 3. Are overdue and eligible for a mammogram per Health Maintenance 4. 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: 1. Medicare Insurance 2. Medicaid Insurance 3. No EHR patient portal account 4. Zero log-ins to EHR patient portal in the previous year
Exclusion criteria
Patients will be excluded from the study if: 1. History of bilateral mastectomy 2. Have a mammogram exclusion modifier in Health Maintenance 3. Have no phone number (home or mobile) listed in their chart (Penn Trial only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Complete a Screening Mammogram Within 3 Months After the Visit | 3 months | The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Complete a Screening Mammogram Within 6 Months After the Visit | 6 months | The secondary outcome is screening mammogram completion within 6 months after the first eligible primary care visit. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmol Navathe, MD, PhD
University of Pennsylvania
Participant flow
Recruitment details
Waiver of informed consent obtained. Penn patients were identified 1 day prior to an eligible primary care visit between 12/18/23-7/1/24. UH patients were identified 1-3 days prior to an eligible primary care visit between 2/7/24-10/7/24. Patients only counted once within the study window at their first primary care visit. Total protocol enrollment: 21,123 patients (14,905 at Penn and 6,218 at UH). No clinicians were individually enrolled as participants and no clinician outcomes were evaluated.
Pre-assignment details
Penn clinics were randomized 2:1 to intervention and control. Penn patients seen at an intervention clinic and identified as high risk were further randomized 1:1 to standard messaging or an intensification nudge. UH primary care providers were randomized 1:1 to intervention or control. No individual randomization took place at UH.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 9.7 |
| Insurance Type Commercial | 6377 Participants |
| Insurance Type Medicaid | 1041 Participants |
| Insurance Type Medicare | 680 Participants |
| Insurance Type Other | 149 Participants |
| Race/Ethnicity, Customized Hispanic Latino | 73 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 2843 Participants |
| Race/Ethnicity, Customized Unknown | 113 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 707 Participants |
| Race (NIH/OMB) Black or African American | 2176 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 35 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 444 Participants |
| Race (NIH/OMB) White | 13168 Participants |
| Sex: Female, Male Female | 10392 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 4,513 | 59 / 10,392 | 1 / 3,075 | 1 / 3,143 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed