- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03480217
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
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Center for Behavioral Cardiovascular Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
- Prescribed antihypertensive medication
- 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
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: Multifaceted Implementation Strategy
Patients will be screened for hypertension by primary care providers, registered nurses, medical assistants, and front desk staff from clinics randomized to receive the intervention, Multifaceted Implementation Strategy.
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Key components include:
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No Intervention: Usual Care
Patients will be screened for hypertension by primary care providers, nurses, medical assistants, and front desk staff of clinics randomized to the usual care group that do not intentionally receive any parts of the multifaceted implementation strategy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in proportion of eligible patients who completed out-of-office BP testing post-implementation
Time Frame: 12 months
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By recording patients with elevated office BP and no prior diagnosis of hypertension who completed ABPM or HBPM test from pre-implementation (date of visits with elevated office BP: October 1, 2016 to September 30, 2017) to post-implementation (date of visits with elevated office BP: April 1, 2018 to March 31, 2019)
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in proportion of eligible patients who completed out-of-office BP testing during maintenance period
Time Frame: 24 months
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By recording patients with elevated office BP and no prior diagnosis of hypertension who completed ABPM or HBPM test from pre-implementation (date of eligible visits with elevated office BP: October 1, 2016 to September 30, 2017) to maintenance period (date of eligible visits with elevated office BP: April 1, 2019 to March 31, 2020)
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24 months
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Change in proportion of scheduled clinic visits with appropriate out-of-office BP test ordering post-implementation
Time Frame: 12 months
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By recording scheduled clinic visits with patients who have elevated office BP and no prior diagnosis of hypertension at which providers order ABPM or HBPM test from pre-implementation period (October 1, 2016 to September 30, 2017) to post-implementation period (April 1, 2018 to March 31, 2019)
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12 months
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Change in proportion of scheduled clinic visits with appropriate out-of-office BP test ordering during maintenance period
Time Frame: 24 months
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By recording scheduled clinic visits with patients who have elevated office BP and no prior diagnosis of hypertension at which providers order ABPM or HBPM test from pre-implementation period (October 1, 2016 to September 30, 2017) to post-implementation period (April 1, 2019 to March 31, 2020)
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24 months
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Change in proportion of patients with newly diagnosed white-coat hypertension post-implementation
Time Frame: 12 months
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By recording patients with newly diagnosed white-coat hypertension from pre-implementation period (date of visits with elevated office BP: October 1, 2016 to September 30, 2017) to post-implementation period (date of visits with elevated office BP: April 1, 2018 to March 31, 2019)
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12 months
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Change in proportion of patients with newly diagnosed white-coat hypertension during maintenance period
Time Frame: 24 months
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By recording patients with newly diagnosed white-coat hypertension from pre-implementation period (date of visits with elevated office BP: October 1, 2016 to September 30, 2017) to maintenance period (date of visits with elevated office BP: April 1, 2019 to March 31, 2020)
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24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ian Kronish, MD, Columbia University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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