Trial Outcomes & Findings for Increasing Screening for Cancer Using EHR-Nudges (NCT NCT06177795)
NCT ID: NCT06177795
Last Updated: 2026-07-06
Results Overview
The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21123 participants
Primary outcome timeframe
3 months
Results posted on
2026-07-06
Participant Flow
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.
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.
Unit of analysis: Primary Care Clinics/Provider Practice
Participant milestones
| Measure |
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.
|
Penn: High Risk - Standard Messaging
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 standard messaging arm received the same standard messaging as average risk patients.
|
Penn: High Risk - Intensification Messaging
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 received an additional bidirectional texting component.
|
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.
|
|---|---|---|---|---|---|---|
|
Cluster Level Randomization
STARTED
|
4513 10
|
10392 20
|
0 0
|
0 0
|
3075 41
|
3143 42
|
|
Cluster Level Randomization
COMPLETED
|
4513 10
|
10392 20
|
0 0
|
0 0
|
3075 36
|
3143 36
|
|
Cluster Level Randomization
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 5
|
0 6
|
|
Individual Level Randomization (Penn)
STARTED
|
0 0
|
0 0
|
2270 0
|
2260 0
|
0 0
|
0 0
|
|
Individual Level Randomization (Penn)
COMPLETED
|
0 0
|
0 0
|
2270 0
|
2260 0
|
0 0
|
0 0
|
|
Individual Level Randomization (Penn)
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Screening for Cancer Using EHR-Nudges
Baseline characteristics by cohort
| Measure |
Penn: Control
n=4513 Participants
Clinics randomized to the control arm will receive standard of care.
|
Penn: Intervention
n=10392 Participants
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.
|
UH: Control
n=3075 Participants
Primary care providers randomized to the control arm will receive standard of care.
|
UH: Intervention
n=3143 Participants
Primary care providers randomized to the intervention arm will receive default pended orders for a mammogram.
|
Total
n=21123 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 10.1 • n=9 Participants
|
56.3 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
57.9 years
STANDARD_DEVIATION 9.7 • n=267 Participants
|
57.9 years
STANDARD_DEVIATION 9.6 • n=265 Participants
|
56.6 years
STANDARD_DEVIATION 10.1 • n=568 Participants
|
|
Sex: Female, Male
Female
|
4513 Participants
n=9 Participants
|
10392 Participants
n=27 Participants
|
3075 Participants
n=267 Participants
|
3143 Participants
n=265 Participants
|
21123 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
19 Participants
n=9 Participants
|
26 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
54 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
159 Participants
n=9 Participants
|
466 Participants
n=27 Participants
|
44 Participants
n=267 Participants
|
38 Participants
n=265 Participants
|
707 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
12 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
35 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2176 Participants
n=9 Participants
|
2841 Participants
n=27 Participants
|
259 Participants
n=267 Participants
|
252 Participants
n=265 Participants
|
5528 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
1703 Participants
n=9 Participants
|
6132 Participants
n=27 Participants
|
2626 Participants
n=267 Participants
|
2707 Participants
n=265 Participants
|
13168 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
444 Participants
n=9 Participants
|
907 Participants
n=27 Participants
|
138 Participants
n=267 Participants
|
142 Participants
n=265 Participants
|
1631 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Hispanic Latino
|
235 Participants
n=9 Participants
|
401 Participants
n=27 Participants
|
73 Participants
n=267 Participants
|
46 Participants
n=265 Participants
|
755 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4165 Participants
n=9 Participants
|
9713 Participants
n=27 Participants
|
2736 Participants
n=267 Participants
|
2843 Participants
n=265 Participants
|
19457 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
113 Participants
n=9 Participants
|
278 Participants
n=27 Participants
|
266 Participants
n=267 Participants
|
254 Participants
n=265 Participants
|
911 Participants
n=568 Participants
|
|
Insurance Type
Medicare
|
1014 Participants
n=9 Participants
|
2590 Participants
n=27 Participants
|
680 Participants
n=267 Participants
|
691 Participants
n=265 Participants
|
4975 Participants
n=568 Participants
|
|
Insurance Type
Medicaid
|
840 Participants
n=9 Participants
|
1041 Participants
n=27 Participants
|
94 Participants
n=267 Participants
|
108 Participants
n=265 Participants
|
2083 Participants
n=568 Participants
|
|
Insurance Type
Commercial
|
2510 Participants
n=9 Participants
|
6377 Participants
n=27 Participants
|
2220 Participants
n=267 Participants
|
2279 Participants
n=265 Participants
|
13386 Participants
n=568 Participants
|
|
Insurance Type
Other
|
149 Participants
n=9 Participants
|
384 Participants
n=27 Participants
|
81 Participants
n=267 Participants
|
65 Participants
n=265 Participants
|
679 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
Outcome measures
| Measure |
Penn: Control
n=4513 Participants
Clinics randomized to the control arm will receive standard of care.
|
Penn: Intervention
n=10392 Participants
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.
|
Penn: High Risk - Standard Messaging
n=2270 Participants
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 standard messaging arm received the same standard messaging as average risk patients.
|
Penn: High Risk - Intensification Messaging
n=2260 Participants
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 received an additional bidirectional texting component.
|
UH: Control
n=3075 Participants
Primary care providers randomized to the control arm will receive standard of care.
|
UH: Intervention
n=3143 Participants
Primary care providers randomized to the intervention arm will receive default pended orders for a mammogram.
|
|---|---|---|---|---|---|---|
|
Proportion of Patients Who Complete a Screening Mammogram Within 3 Months After the Visit
|
943 Participants
|
2810 Participants
|
511 Participants
|
549 Participants
|
1167 Participants
|
1390 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe secondary outcome is screening mammogram completion within 6 months after the first eligible primary care visit.
Outcome measures
| Measure |
Penn: Control
n=4513 Participants
Clinics randomized to the control arm will receive standard of care.
|
Penn: Intervention
n=10392 Participants
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.
|
Penn: High Risk - Standard Messaging
n=2270 Participants
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 standard messaging arm received the same standard messaging as average risk patients.
|
Penn: High Risk - Intensification Messaging
n=2260 Participants
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 received an additional bidirectional texting component.
|
UH: Control
n=3075 Participants
Primary care providers randomized to the control arm will receive standard of care.
|
UH: Intervention
n=3143 Participants
Primary care providers randomized to the intervention arm will receive default pended orders for a mammogram.
|
|---|---|---|---|---|---|---|
|
Proportion of Patients Who Complete a Screening Mammogram Within 6 Months After the Visit
|
1401 Participants
|
3912 Participants
|
732 Participants
|
751 Participants
|
1417 Participants
|
1620 Participants
|
Adverse Events
Penn: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Penn: Intervention
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
UH: Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
UH: Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Penn: Control
n=4513 participants at risk
Clinics randomized to the control arm will receive standard of care.
|
Penn: Intervention
n=10392 participants at risk
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.
|
UH: Control
n=3075 participants at risk
Primary care providers randomized to the control arm will receive standard of care.
|
UH: Intervention
n=3143 participants at risk
Primary care providers randomized to the intervention arm will receive default pended orders for a mammogram.
|
|---|---|---|---|---|
|
Social circumstances
Messaging Opt-out
|
—
0/0 • Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.
Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death or serious injury would result from outreach to encourage standard clinical care for breast cancer screening. Therefore, All-Cause Mortality and Serious AEs was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.
|
0.49%
51/10392 • Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.
Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death or serious injury would result from outreach to encourage standard clinical care for breast cancer screening. Therefore, All-Cause Mortality and Serious AEs was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.
|
0.00%
0/3075 • Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.
Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death or serious injury would result from outreach to encourage standard clinical care for breast cancer screening. Therefore, All-Cause Mortality and Serious AEs was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.
|
0.00%
0/3143 • Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.
Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death or serious injury would result from outreach to encourage standard clinical care for breast cancer screening. Therefore, All-Cause Mortality and Serious AEs was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.
|
|
Surgical and medical procedures
Duplicate Mammogram
|
0.00%
0/4513 • Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.
Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death or serious injury would result from outreach to encourage standard clinical care for breast cancer screening. Therefore, All-Cause Mortality and Serious AEs was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.
|
0.08%
8/10392 • Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.
Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death or serious injury would result from outreach to encourage standard clinical care for breast cancer screening. Therefore, All-Cause Mortality and Serious AEs was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.
|
0.03%
1/3075 • Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.
Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death or serious injury would result from outreach to encourage standard clinical care for breast cancer screening. Therefore, All-Cause Mortality and Serious AEs was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.
|
0.03%
1/3143 • Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.
Per our DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death or serious injury would result from outreach to encourage standard clinical care for breast cancer screening. Therefore, All-Cause Mortality and Serious AEs was not assessed. AEs are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place