Implementing Hypertension Screening Guidelines in Primary Care

NCT03480217 | Completed Results

• 2 other identifiers: AAAQ10621R01HS024262-01
• Study Type: interventional
• Target: 1,186
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension,Essential; White Coat Hypertension

Keywords

hypertension; screening; guidelines; implementation; randomized

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  6 months (Pre-Implementation period)

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

  6 months (Post-Implementation period)

Study Arms (4)

Intervention Clinics, Pre-Implementation

EXPERIMENTAL

Usual care

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.

Behavioral: Multifaceted Implementation Strategy

Control Clinics, Pre-Implementation

OTHER

Usual care

Other: Usual care

Control Clinics, Post-Implementation

OTHER

Usual care

Other: Usual care

Interventions

Multifaceted Implementation Strategy BEHAVIORAL

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

Intervention Clinics, Post-Implementation

Usual care OTHER

Primary care clinicians diagnose hypertension according to usual care

Control Clinics, Post-Implementation; Control Clinics, Pre-Implementation; Intervention Clinics, Pre-Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Primary care clinics that are part of the New York-Presbyterian Hospital Ambulatory Care Network and were not part of implementation development
• Medical director of clinic declines to participate in cluster randomized trial

Sponsors & Collaborators

• Columbia University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (2)

Center for Behavioral Cardiovascular Health

New York, New York, 10032, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Related Publications (7)

• 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.

  PMID: 26458123 BACKGROUND

• Kronish 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.

  PMID: 28734798 BACKGROUND

• Piper 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.

  PMID: 25531400 BACKGROUND

• Moise 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.

  PMID: 32771002 BACKGROUND

• Carter 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.

  PMID: 29788130 BACKGROUND

• Kronish 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.

  PMID: 37747734 RESULT

• Kronish 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. 2025 Oct 14. doi: 10.1007/s11606-025-09840-9. Online ahead of print.

  PMID: 41085961 DERIVED

MeSH Terms

Conditions

Essential Hypertension; White Coat Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The Coronavirus Disease 2019 (COVID-19) pandemic led to the closure of the ABPM testing service during the maintenance period which precluded an evaluation of the implementation strategy during the maintenance period. Additionally, a new electronic health record was adopted in 2020 which also precluded an evaluation of the use of HBPM during the maintenance period.

Results Point of Contact

• Title: Ian Kronish
• Organization: Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center

ik2293@columbia.edu

212-342-1335

Study Officials

• Ian Kronish, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Florence Irving Associate Professor of Medicine

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: April 1, 2018
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Within 1 year of completion of study activities
• Access Criteria: Access to the data archive will be provided upon request.

Locations

US (2)