Hypertension,EssentialEMBRACENCT03480217
Implementing Hypertension Screening Guidelines in Primary Care
A study testing Multifaceted Implementation Strategy in people with Hypertension,Essential and White Coat Hypertension, run by Columbia University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension,Essential, White Coat Hypertension
- What is being tested?
- Multifaceted Implementation Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,186 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2018to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Behavioral Cardiovascular Health
New York, New York, 10032
Weill Cornell Medical Center
New York, New York, 10065
About this study
Official title: 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.
Read the 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).
- Conditions
- Hypertension,Essential, White Coat Hypertension
- Being tested
- Multifaceted Implementation Strategy, Usual care
- Keywords
- hypertension, screening, guidelines, implementation, randomized
- Medical subject headings
- Essential Hypertension, White Coat Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted Implementation StrategyBehavioural
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
Usual careOther
Primary care clinicians diagnose hypertension according to usual care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Clinics, Pre-Implementation | Experimental | Usual care Receives: Other: Usual care |
| Intervention Clinics, Post-Implementation | Experimental | 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. Receives: Behavioral: Multifaceted Implementation Strategy |
| Control Clinics, Pre-Implementation | Other | Usual care Receives: Other: Usual care |
| Control Clinics, Post-Implementation | Other | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 6 months (Post-Implementation period)
Secondary outcomes (2)
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.
Measured: 6 months (Pre-Implementation period)
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.
Measured: 6 months (Post-Implementation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Ian Kronish, Columbia University
- Investigators
- Ian Kronish, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480217
- Sponsor's protocol ID
- AAAQ1062
- Other IDs
- 1R01HS024262-01
- Acronym
- EMBRACE
- Status last verified
- May 2025
- First submitted
- 21 Mar 2018
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified data archive that contains raw study data will be posted on an open science platform.
Publications
Siu AL; U.S. Preventive Services Task Force. Screening for high blood pressure in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015 Nov 17;163(10):778-86. doi: 10.7326/M15-2223. Epub 2015 Oct 13.
PubMed 26458123Kronish IM, Kent S, Moise N, Shimbo D, Safford MM, Kynerd RE, O'Beirne R, Sullivan A, Muntner P. Barriers to conducting ambulatory and home blood pressure monitoring during hypertension screening in the United States. J Am Soc Hypertens. 2017 Sep;11(9):573-580. doi: 10.1016/j.jash.2017.06.012. Epub 2017 Jul 6.
PubMed 28734798Piper MA, Evans CV, Burda BU, Margolis KL, O'Connor E, Whitlock EP. Diagnostic and predictive accuracy of blood pressure screening methods with consideration of rescreening intervals: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2015 Feb 3;162(3):192-204. doi: 10.7326/M14-1539.
PubMed 25531400Moise N, Phillips E, Carter E, Alcantara C, Julian J, Thanataveerat A, Schwartz JE, Ye S, Duran A, Shimbo D, Kronish IM. Design and study protocol for a cluster randomized trial of a multi-faceted implementation strategy to increase the uptake of the USPSTF hypertension screening recommendations: the EMBRACE study. Implement Sci. 2020 Aug 8;15(1):63. doi: 10.1186/s13012-020-01017-8.
PubMed 32771002Carter EJ, Moise N, Alcantara C, Sullivan AM, Kronish IM. Patient Barriers and Facilitators to Ambulatory and Home Blood Pressure Monitoring: A Qualitative Study. Am J Hypertens. 2018 Jul 16;31(8):919-927. doi: 10.1093/ajh/hpy062.
PubMed 29788130Kronish IM, Phillips E, Alcantara C, Carter E, Schwartz JE, Shimbo D, Serafini M, Boyd R, Chang M, Wang X, Razon D, Patel A, Moise N. A Multifaceted Implementation Strategy to Increase Out-of-Office Blood Pressure Monitoring: The EMBRACE Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2334646. doi: 10.1001/jamanetworkopen.2023.34646.
PubMed 37747734Kronish IM, Carter E, Phillips E, Alcantara C, Serafini M, Schwartz JE, Moise N. Impact of a Theory-Informed Implementation Strategy on Clinician Attitudes Toward Out-of-Office Blood Pressure Monitoring for Hypertension Screening. J Gen Intern Med. 2026 Mar;41(4):1107-1115. doi: 10.1007/s11606-025-09840-9. Epub 2025 Oct 14.
PubMed 41085961
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03480217
- Acronym / sponsor ID
- EMBRACE / AAAQ1062
- Conditions
- Hypertension,Essential, White Coat Hypertension
- Keywords
- hypertension, screening, guidelines, implementation, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,186 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Weill Medical College of Cornell University
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Clinics, Pre-Implementation | Experimental | Other: Usual careUsual care |
| Intervention Clinics, Post-Implementation | Experimental | Behavioral: Multifaceted Implementation StrategyPatients 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. |
| Control Clinics, Pre-Implementation | Other | Other: Usual careUsual care |
| Control Clinics, Post-Implementation | Other | Other: Usual careUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted Implementation StrategyKey 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 | Behavioural | Intervention Clinics, Post-Implementation |
| Usual carePrimary care clinicians diagnose hypertension according to usual care | Other | Control Clinics, Post-Implementation, Control Clinics, Pre-Implementation, Intervention Clinics, Pre-Implementation |
Primary outcome
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.
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.
2 secondary outcomes
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26458123Siu AL; U.S. Preventive Services Task Force. Screening for high blood pressure in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015 Nov 17;163(10):778-86. doi: 10.7326/M15-2223. Epub 2015 Oct 13.
- Background: PubMed 28734798Kronish IM, Kent S, Moise N, Shimbo D, Safford MM, Kynerd RE, O'Beirne R, Sullivan A, Muntner P. Barriers to conducting ambulatory and home blood pressure monitoring during hypertension screening in the United States. J Am Soc Hypertens. 2017 Sep;11(9):573-580. doi: 10.1016/j.jash.2017.06.012. Epub 2017 Jul 6.
- Background: PubMed 25531400Piper MA, Evans CV, Burda BU, Margolis KL, O'Connor E, Whitlock EP. Diagnostic and predictive accuracy of blood pressure screening methods with consideration of rescreening intervals: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2015 Feb 3;162(3):192-204. doi: 10.7326/M14-1539.
- Background: PubMed 32771002Moise N, Phillips E, Carter E, Alcantara C, Julian J, Thanataveerat A, Schwartz JE, Ye S, Duran A, Shimbo D, Kronish IM. Design and study protocol for a cluster randomized trial of a multi-faceted implementation strategy to increase the uptake of the USPSTF hypertension screening recommendations: the EMBRACE study. Implement Sci. 2020 Aug 8;15(1):63. doi: 10.1186/s13012-020-01017-8.
- Background: PubMed 29788130Carter EJ, Moise N, Alcantara C, Sullivan AM, Kronish IM. Patient Barriers and Facilitators to Ambulatory and Home Blood Pressure Monitoring: A Qualitative Study. Am J Hypertens. 2018 Jul 16;31(8):919-927. doi: 10.1093/ajh/hpy062.
- Results publication: PubMed 37747734Kronish IM, Phillips E, Alcantara C, Carter E, Schwartz JE, Shimbo D, Serafini M, Boyd R, Chang M, Wang X, Razon D, Patel A, Moise N. A Multifaceted Implementation Strategy to Increase Out-of-Office Blood Pressure Monitoring: The EMBRACE Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2334646. doi: 10.1001/jamanetworkopen.2023.34646.
- Derived from this study: PubMed 41085961Kronish IM, Carter E, Phillips E, Alcantara C, Serafini M, Schwartz JE, Moise N. Impact of a Theory-Informed Implementation Strategy on Clinician Attitudes Toward Out-of-Office Blood Pressure Monitoring for Hypertension Screening. J Gen Intern Med. 2026 Mar;41(4):1107-1115. doi: 10.1007/s11606-025-09840-9. Epub 2025 Oct 14.
- Individual participant dataSharing planned: Yes. A de-identified data archive that contains raw study data will be posted on an open science platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Kronish, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted Implementation Strategy in people with Hypertension,Essential and White Coat Hypertension, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480217, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.