Implementing Hypertension Screening Guidelines in Primary Care

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-10-01

Brief Summary

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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.

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Detailed Description

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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

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Hypertension,Essential White Coat Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Intervention Clinics, Pre-Implementation

Usual care

Group Type EXPERIMENTAL

Usual care

Intervention Type OTHER

Primary care clinicians diagnose hypertension according to usual care

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.

Group Type EXPERIMENTAL

Multifaceted Implementation Strategy

Intervention Type 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

Control Clinics, Pre-Implementation

Usual care

Group Type OTHER

Usual care

Intervention Type OTHER

Primary care clinicians diagnose hypertension according to usual care

Control Clinics, Post-Implementation

Usual care

Group Type OTHER

Usual care

Intervention Type OTHER

Primary care clinicians diagnose hypertension according to usual care

Interventions

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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

Intervention Type BEHAVIORAL

Usual care

Primary care clinicians diagnose hypertension according to usual care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* Primary care clinics that are part of the New York-Presbyterian Hospital Ambulatory Care Network and were not part of implementation development

Exclusion Criteria

* 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)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No