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Implementing Hypertension Screening Guidelines in Primary Care

Assessing the Effectiveness of a Multifaceted Implementation Strategy to Increase the Uptake of the USPSTF Hypertension Screening Recommendations in an Ambulatory Care Network: a Cluster Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03480217
Acronym
EMBRACE
Enrollment
1186
Registered
2018-03-29
Start date
2018-04-01
Completion date
2022-10-01
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension,Essential, White Coat Hypertension

Keywords

hypertension, screening, guidelines, implementation, randomized

Brief summary

The goal of this study is to use a cluster-randomized design (1:1 ratio) among 8 primary care clinics affiliated with New York-Presbyterian Hospital to test the effectiveness of a theory-informed multifaceted implementation strategy designed to increase the uptake of the 2015 United States Preventive Services Task Force (USPSTF) hypertension screening guidelines. The primary outcome is the ordering of out-of-office blood pressure testing, either ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM), by primary care clinicians for patients with newly elevated office blood pressure (BP), as recommended by the 2015 guidelines.

Detailed description

The goal of this study is to assess the effect of a multifaceted implementation strategy aimed at increasing adherence to the 2015 U.S. Preventive Services Task Force (USPSTF) recommendations for hypertension screening, with a focus on implementation in primary care clinics that reach medically underserved patients. The accurate diagnosis of hypertension is essential for targeting appropriate therapy at the patients who can most benefit from hypertension treatment. On the other hand, inappropriate diagnosis of hypertension can lead to unnecessary treatment with blood pressure (BP) medications, wasteful healthcare utilization, and adverse psychological consequences from being mislabeled as having a chronic disease. There are challenges to measuring BP in clinical settings that make inappropriate diagnosis common. A systematic review conducted by the USPSTF in 2014 found that 5%-65% of patients with elevated office BP do not have high out-of-office BP readings according to ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM). This is commonly referred to as white-coat hypertension. In contrast to patients with sustained hypertension (elevated BP in office and out-of-office settings), patients with white-coat hypertension do not appear to be at increased cardiovascular risk nor to benefit from antihypertensive treatment. Based primarily on these observations, in 2015, the USPSTF updated their hypertension screening guidelines to recommend that patients with elevated office BP undergo out-of-office BP testing (ABPM or HBPM) to rule-out white-coat hypertension prior to a new diagnosis of hypertension. While ABPM is recommended as the first-line out-of-office screening test, HBPM is cited as a reasonable alternative if ABPM is unavailable. Despite the USPSTF guideline recommendation, ABPM and HBPM are currently infrequently utilized in the US, particularly as part of hypertension diagnosis. Accordingly, the investigators conducted focus groups with primary care providers, patients, and other key stakeholders (medical directors, nurse supervisors, medical assistants, nurse practitioners, front desk staff) to identify the major barriers to implementation of the new hypertension screening guidelines. The investigators then applied the Behavior Change Wheel, a trans-theoretical intervention development framework, to categorize barriers and select theory-informed intervention components that would address these barriers. The investigators arrived at a theory-informed implementation strategy for improving out-of-office BP testing, which included educational activities for providers (i.e., presentations at grand rounds or other venues at which physicians are present); training registered nurses to be capable of assisting with teaching patients to conduct HBPM; disseminating information on how to order ABPM and HBPM to clinicians, nurses, and front desk staff via huddles, emails, and other electronic communications; creating a computerized electronic health record (EHR)-embedded clinical decision support tool that prompts recall of the USPSTF hypertension guidelines and facilitates ordering of HBPM and ABPM for eligible patients; creating and disseminating patient information materials on ABPM and HBPM; providing periodic feedback about clinic-level success with adhering to the guideline, and developing an easily accessible, culturally-adapted and locally tailored ABPM service. The investigators now aim to test this multifaceted implementation strategy to increase the uptake of the USPSTF hypertension recommendations in the ambulatory care network (ACN) of New York-Presbyterian Hospital (NYP), a network of primary care clinics serving 120,000 patients from underserved communities in New York City. Specifically, the investigators are conducting a 2-year cluster randomized trial (Phase II of the project) following a 6-month implementation phase in which we randomize matched pairs of 8 ACN clinics (1:1) to either receive the multicomponent guideline implementation strategy (N = 4 clinics) or a wait-list control (N = 4 clinics). The investigators aim to assess the effectiveness of this intervention on the completion of out-of-office BP testing (ABPM or HBPM) prior to hypertension diagnosis (primary outcome) as well as the effect on out-of-office test ordering, irrespective of test completion (secondary outcome).

Interventions

Key components include: * educational presentations to primary care providers at grand rounds * patient information materials on ABPM and HBPM * training registered nurses to assist providers with teaching patients to conduct HBPM * information on how to order ABPM and HBPM to clinicians, nurses and front desk staff via huddles, emails, and other electronic communications * a computerized EHR-embedded clinical decision support tool that prompts providers to recall the USPSTF hypertension guidelines and facilitates ordering of HBPM and ABPM for guideline-eligible patients * periodic feedback to primary care providers about clinic-level success with appropriately ordering ABPM and HBPM for eligible patients * an accessible, culturally-adapted and locally tailored ABPM service

OTHERUsual care

Primary care clinicians diagnose hypertension according to usual care

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Weill Medical College of Cornell University
CollaboratorOTHER
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessors will be blinded to group assignment when coding medical records to determine whether providers ordered out-of-office BP testing for eligible patients.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient Inclusion Criteria (as per electronic medical records): * Elevated blood pressure (BP) (systolic BP\>=140 mmHg or diastolic BP \>=90 mmHg) at a scheduled clinic visit with a primary care provider from a clinic that is participating in the study; if multiple BP readings were taken from a visit, then the average of the readings will be used Patient

Exclusion criteria

(as per electronic medical records): * Prior diagnosis of hypertension * Prior diagnosis of white-coat hypertension * Prior evaluation for white-coat hypertension by 24-hr ABPM or HBPM * Prescribed antihypertensive medication * Manual office BP \<140/90 mmHg * Severely elevated BP (systolic BP\>=180 mmHg or diastolic BP\>=110 mmHg) * Evidence of target-organ damage (chronic kidney disease, cardiovascular disease) Clinic Inclusion Criteria: * Primary care clinics that are part of the New York-Presbyterian Hospital Ambulatory Care Network and were not part of implementation development Clinic

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period6 months (Pre-Implementation period)Patient completed out-of-office BP testing \[ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM)\] (either Y/N) per eligible visits were tallied.
Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Post-Implementation Period6 months (Post-Implementation period)Patient completed out-of-office BP testing \[ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM)\] (either Y/N) per eligible visits were tallied.

Secondary

MeasureTime frameDescription
Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Post-Implementation Period6 months (Post-Implementation period)Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.
Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Pre-Implementation Period6 months (Pre-Implementation period)Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.

Countries

United States

Participant flow

Recruitment details

Patients were passively recruited from the electronic health record.

Pre-assignment details

This 2-group, pre-post cluster randomized trial was conducted within a primary care network of 8 practices and 1186 patients (857 intervention; 329 control). Depending on the practice/clinic and the implementation period, patients will receive usual care or care that has been impacted by the multifaceted implementation strategy.

Participants by arm

ArmCount
Intervention Clinics (Pre-Implementation)
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive the implementation strategy before the multifaceted implementation strategy had been delivered (i.e., pre-implementation period, no exposure to intervention)
456
Intervention Clinics (Post-Implementation)
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive the implementation strategy after the multifaceted implementation strategy had been delivered (i.e., post-implementation period, exposure to intervention)
401
Control (Usual Care) Clinics (Pre-Implementation)
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to not receive the multifaceted implementation strategy and receive usual care before the implementation period begins (i.e., pre-implementation period, no exposure to intervention)
139
Control (Usual Care) Clinics (Post-Implementation)
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to not receive the multifaceted implementation strategy and receive usual care after the implementation period begins (i.e., post-implementation period, no exposure to intervention)
190
Total1,186

Baseline characteristics

CharacteristicIntervention Clinics (Pre-Implementation)TotalControl (Usual Care) Clinics (Post-Implementation)Control (Usual Care) Clinics (Pre-Implementation)Intervention Clinics (Post-Implementation)
Age, Continuous51.6 years
STANDARD_DEVIATION 14.1
53.6 years
STANDARD_DEVIATION 15.7
59.8 years
STANDARD_DEVIATION 19.1
58.9 years
STANDARD_DEVIATION 16
51.3 years
STANDARD_DEVIATION 14.5
Ethnicity (NIH/OMB)
Hispanic or Latino
152 Participants368 Participants53 Participants50 Participants113 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
70 Participants209 Participants43 Participants17 Participants79 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
234 Participants609 Participants94 Participants72 Participants209 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
53 Participants123 Participants11 Participants9 Participants50 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
317 Participants818 Participants122 Participants97 Participants282 Participants
Race (NIH/OMB)
White
86 Participants245 Participants57 Participants33 Participants69 Participants
Region of Enrollment
United States
456 participants1186 participants190 participants139 participants401 participants
Sex: Female, Male
Female
289 Participants808 Participants157 Participants105 Participants257 Participants
Sex: Female, Male
Male
167 Participants378 Participants33 Participants34 Participants144 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 8570 / 329
other
Total, other adverse events
0 / 8570 / 329
serious
Total, serious adverse events
0 / 8570 / 329

Outcome results

Primary

Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Post-Implementation Period

Patient completed out-of-office BP testing \[ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM)\] (either Y/N) per eligible visits were tallied.

Time frame: 6 months (Post-Implementation period)

ArmMeasureValue (NUMBER)
Intervention ClinicsPercentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Post-Implementation Period5.7 percentage of visits
Control ClinicsPercentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Post-Implementation Period4.3 percentage of visits
Primary

Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period

Patient completed out-of-office BP testing \[ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM)\] (either Y/N) per eligible visits were tallied.

Time frame: 6 months (Pre-Implementation period)

ArmMeasureValue (NUMBER)
Intervention ClinicsPercentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period0.6 percentage of visits
Control ClinicsPercentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period5.4 percentage of visits
Secondary

Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Post-Implementation Period

Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.

Time frame: 6 months (Post-Implementation period)

ArmMeasureValue (NUMBER)
Intervention ClinicsPercentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Post-Implementation Period7.9 percentage of visits
Control ClinicsPercentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Post-Implementation Period9.2 percentage of visits
Secondary

Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Pre-Implementation Period

Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.

Time frame: 6 months (Pre-Implementation period)

ArmMeasureValue (NUMBER)
Intervention ClinicsPercentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Pre-Implementation Period2.8 percentage of visits
Control ClinicsPercentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Pre-Implementation Period8.7 percentage of visits

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026