Implementing Hypertension Screening Guidelines in Primary Care (EMBRACE)

May 21, 2025 updated by: Ian Kronish, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

1186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical Center
      • New York, New York, United States, 10032
        • Center for Behavioral Cardiovascular Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Exclusion Criteria:

  • Medical director of clinic declines to participate in cluster randomized trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Clinics, Pre-Implementation
Usual care
Other: Usual care
Primary care clinicians diagnose hypertension according to usual care
Experimental: Intervention Clinics, Post-Implementation
Patients will be screened for hypertension by primary care clinicians, registered nurses, medical assistants, and front desk staff from clinics randomized to receive the Multifaceted Implementation Strategy.
Behavioral: Multifaceted Implementation Strategy

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
Other: Control Clinics, Pre-Implementation
Usual care
Other: Usual care
Primary care clinicians diagnose hypertension according to usual care
Other: Control Clinics, Post-Implementation
Usual care
Other: Usual care
Primary care clinicians diagnose hypertension according to usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period
Time Frame: 6 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.
6 months (Pre-Implementation period)
Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Post-Implementation Period
Time Frame: 6 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.
6 months (Post-Implementation period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Pre-Implementation Period
Time Frame: 6 months (Pre-Implementation period)
Primary care clinician ordered out-of-office BP testing [ABPM or HBPM] (either Y/N) for eligible visits were tallied.
6 months (Pre-Implementation period)
Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Post-Implementation Period
Time Frame: 6 months (Post-Implementation period)
Primary care clinician ordered out-of-office BP testing [ABPM or HBPM] (either Y/N) for eligible visits were tallied.
6 months (Post-Implementation period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Weill Medical College of Cornell University
Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Ian Kronish, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAQ1062
  • 1R01HS024262-01 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified data archive that contains raw study data will be posted on an open science platform.

IPD Sharing Time Frame

Within 1 year of completion of study activities

IPD Sharing Access Criteria

Access to the data archive will be provided upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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