Trial Outcomes & Findings for Pediatric Blood Pressure Clinical Decision Support Tool (PedsBP CDS) (NCT NCT05126082)
NCT ID: NCT05126082
Last Updated: 2026-01-22
Results Overview
Number of participants with blood pressure re-measurement at the index primary care encounter, among those with a first elevated blood pressure at the index primary care encounter.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41054 participants
Primary outcome timeframe
Within the index primary care encounter
Results posted on
2026-01-22
Participant Flow
Providers did not give consent and are not included in the enrollment number. Only patient participants were considered enrolled. Patient participants received care in line with the study arm/group assignment of the primary care clinic in which they received care.
Unit of analysis: Primary Care Clinics
Participant milestones
| Measure |
Control
Primary care clinics were assigned to control arm clinics and will engage in the current standard of care, without access to the PedsBP clinical decision support tool. Providers at those clinics will provide the usual standard of care.
|
Low-Intensity Implementation
Primary care clinics in the low-intensity arm will have access to the PedsBP clinical decision support tool and provider and clinic staff will receive standard training and training resources using the health systems standard training platform.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
High-Intensity Implementation
Primary care clinics in the high-intensity arm will have access to the PedsBP clinical decision support tool and providers and clinic staff will receive enhanced training and training resources, and regular feedback from the project team regarding CDS use rates.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12072 13
|
13900 14
|
15082 13
|
|
Overall Study
Patients Started
|
12072 13
|
13900 14
|
15082 13
|
|
Overall Study
COMPLETED
|
12072 13
|
13900 14
|
15082 13
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Unknown Sex: Control: 1 Low: 2 High: 2
Baseline characteristics by cohort
| Measure |
Control
n=12072 Participants
Providers and patients in control arm clinics will engage in the current standard of care, without access to the PedsBP clinical decision support tool.
|
Low-Intensity Implementation
n=13900 Participants
Providers and patients in the low-intensity arm will have access to the PedsBP clinical decision support tool and will receive standard training and training resources using the health systems standard training platform.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
High-Intensity Implementation
n=15082 Participants
Providers and patients in the high-intensity arm will have access to the PedsBP clinical decision support tool and will receive enhanced training and training resources, and regular feedback from the project team regarding CDS use rates.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
Total
n=41054 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 3.5 • n=12072 Participants
|
11.7 years
STANDARD_DEVIATION 3.6 • n=13900 Participants
|
11.4 years
STANDARD_DEVIATION 3.5 • n=15082 Participants
|
11.5 years
STANDARD_DEVIATION 3.5 • n=41054 Participants
|
|
Sex: Female, Male
Sex · Female
|
5975 Participants
n=12071 Participants • Unknown Sex: Control: 1 Low: 2 High: 2
|
7061 Participants
n=13898 Participants • Unknown Sex: Control: 1 Low: 2 High: 2
|
7448 Participants
n=15080 Participants • Unknown Sex: Control: 1 Low: 2 High: 2
|
20484 Participants
n=41049 Participants • Unknown Sex: Control: 1 Low: 2 High: 2
|
|
Sex: Female, Male
Sex · Male
|
6096 Participants
n=12071 Participants • Unknown Sex: Control: 1 Low: 2 High: 2
|
6837 Participants
n=13898 Participants • Unknown Sex: Control: 1 Low: 2 High: 2
|
7632 Participants
n=15080 Participants • Unknown Sex: Control: 1 Low: 2 High: 2
|
20565 Participants
n=41049 Participants • Unknown Sex: Control: 1 Low: 2 High: 2
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
402 Participants
n=12072 Participants
|
333 Participants
n=13900 Participants
|
299 Participants
n=15082 Participants
|
1034 Participants
n=41054 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11540 Participants
n=12072 Participants
|
13441 Participants
n=13900 Participants
|
14576 Participants
n=15082 Participants
|
39557 Participants
n=41054 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
130 Participants
n=12072 Participants
|
126 Participants
n=13900 Participants
|
207 Participants
n=15082 Participants
|
463 Participants
n=41054 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
380 Participants
n=12072 Participants
|
409 Participants
n=13900 Participants
|
634 Participants
n=15082 Participants
|
1423 Participants
n=41054 Participants
|
|
Race (NIH/OMB)
Asian
|
125 Participants
n=12072 Participants
|
93 Participants
n=13900 Participants
|
148 Participants
n=15082 Participants
|
366 Participants
n=41054 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
47 Participants
n=12072 Participants
|
50 Participants
n=13900 Participants
|
52 Participants
n=15082 Participants
|
149 Participants
n=41054 Participants
|
|
Race (NIH/OMB)
Black or African American
|
779 Participants
n=12072 Participants
|
280 Participants
n=13900 Participants
|
529 Participants
n=15082 Participants
|
1588 Participants
n=41054 Participants
|
|
Race (NIH/OMB)
White
|
10209 Participants
n=12072 Participants
|
12609 Participants
n=13900 Participants
|
13056 Participants
n=15082 Participants
|
35874 Participants
n=41054 Participants
|
|
Race (NIH/OMB)
More than one race
|
172 Participants
n=12072 Participants
|
157 Participants
n=13900 Participants
|
264 Participants
n=15082 Participants
|
593 Participants
n=41054 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
360 Participants
n=12072 Participants
|
302 Participants
n=13900 Participants
|
399 Participants
n=15082 Participants
|
1061 Participants
n=41054 Participants
|
|
Region of Enrollment
United States
|
12072 participants
n=12072 Participants
|
13900 participants
n=13900 Participants
|
15082 participants
n=15082 Participants
|
41054 participants
n=41054 Participants
|
PRIMARY outcome
Timeframe: Within the index primary care encounterPopulation: This is the subset of patients with elevated blood pressure.
Number of participants with blood pressure re-measurement at the index primary care encounter, among those with a first elevated blood pressure at the index primary care encounter.
Outcome measures
| Measure |
Control
n=3051 Participants
Providers and patients assigned to control arm clinics will engage in the current standard of care, without access to the PedsBP clinical decision support tool.
|
Low-Intensity Implementation
n=2903 Participants
Providers and patients in the low-intensity arm will have access to the PedsBP clinical decision support tool and will receive standard training and training resources using the health systems standard training platform.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
High-Intensity Implementation
n=3201 Participants
Providers and patients in the high-intensity arm will have access to the PedsBP clinical decision support tool and will receive enhanced training and training resources, and regular feedback from the project team regarding CDS use rates.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
|---|---|---|---|
|
Blood Pressure Remeasurement
|
245 participants
|
829 participants
|
1813 participants
|
PRIMARY outcome
Timeframe: Within 6 months of the index primary care encounter at which criteria for incident hypertension were met.Population: The analytic sample is the subset of patients who newly met criteria for hypertension and had height measured.
Number of participants with recognition of hypertension within 6 months of meeting incident hypertension criteria. Clinical recognition of hypertension was based on having a diagnosis of elevated BP (R03) or hypertension (I10, I15) or by having these diagnoses added to the problem list.
Outcome measures
| Measure |
Control
n=94 Participants
Providers and patients assigned to control arm clinics will engage in the current standard of care, without access to the PedsBP clinical decision support tool.
|
Low-Intensity Implementation
n=186 Participants
Providers and patients in the low-intensity arm will have access to the PedsBP clinical decision support tool and will receive standard training and training resources using the health systems standard training platform.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
High-Intensity Implementation
n=298 Participants
Providers and patients in the high-intensity arm will have access to the PedsBP clinical decision support tool and will receive enhanced training and training resources, and regular feedback from the project team regarding CDS use rates.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
|---|---|---|---|
|
Hypertension Recognition
|
22 participants
|
37 participants
|
121 participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Low-Intensity Implementation
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
High-Intensity Implementation
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=97 participants at risk
Providers and patients in control arm clinics will engage in the current standard of care, without access to the PedsBP clinical decision support tool.
|
Low-Intensity Implementation
n=189 participants at risk
Providers and patients in the low-intensity arm will have access to the PedsBP clinical decision support tool and will receive standard training and training resources using the health systems standard training platform.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
High-Intensity Implementation
n=310 participants at risk
Providers and patients in the high-intensity arm will have access to the PedsBP clinical decision support tool and will receive enhanced training and training resources, and regular feedback from the project team regarding CDS use rates.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
|---|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/97 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.00%
0/189 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.00%
0/310 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
|
Vascular disorders
Transient Ischemic Attack
|
0.00%
0/97 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.00%
0/189 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.00%
0/310 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/97 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.00%
0/189 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.00%
0/310 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/97 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.00%
0/189 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.00%
0/310 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
Other adverse events
| Measure |
Control
n=97 participants at risk
Providers and patients in control arm clinics will engage in the current standard of care, without access to the PedsBP clinical decision support tool.
|
Low-Intensity Implementation
n=189 participants at risk
Providers and patients in the low-intensity arm will have access to the PedsBP clinical decision support tool and will receive standard training and training resources using the health systems standard training platform.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
High-Intensity Implementation
n=310 participants at risk
Providers and patients in the high-intensity arm will have access to the PedsBP clinical decision support tool and will receive enhanced training and training resources, and regular feedback from the project team regarding CDS use rates.
PedsBP CDS: The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.
|
|---|---|---|---|
|
Surgical and medical procedures
Echocardiogram conducted
|
2.1%
2/97 • Number of events 2 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
1.1%
2/189 • Number of events 2 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
2.6%
8/310 • Number of events 8 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
|
Surgical and medical procedures
Renal Ultrasound Conducted
|
0.00%
0/97 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
1.6%
3/189 • Number of events 3 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.32%
1/310 • Number of events 1 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
|
General disorders
Hospitalization for any cause
|
0.00%
0/97 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.53%
1/189 • Number of events 1 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
3.5%
11/310 • Number of events 11 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
|
Vascular disorders
Order for anti-hypertensive medication
|
2.1%
2/97 • Number of events 2 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
0.53%
1/189 • Number of events 1 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
2.6%
8/310 • Number of events 8 • Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers. Safety data was gathered on all 596 patients who newly met criteria for hypertension.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place