Implementing Hypertension Screening Guidelines in Primary Care



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:4/17/2018
Start Date:April 2, 2018
End Date:July 31, 2020
Contact:Jacob E. Julian
Email:jej2140@cumc.columbia.edu
Phone:716-984-8068

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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.

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).

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
We found this trial at
1
site
622 West 168th Street
New York, New York 10032
Principal Investigator: Ian Kronish, MD
Phone: 716-984-8068
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mi
from
New York, NY
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