Implementing Hypertension Screening Guidelines in Primary Care

Sponsor

Columbia University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03480217

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

2,000

Enrollment

Location

Arms

Anticipated Duration (Months)

39.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension,Essential White Coat Hypertension	Behavioral: Multifaceted Implementation Strategy	N/A

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

Study Type:

Interventional

Actual Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Apr 2, 2018

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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.	Behavioral: 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
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.

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.

Behavioral: 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

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.

Outcome Measures

Primary Outcome Measures

Change in proportion of eligible patients who completed out-of-office BP testing post-implementation [12 months]
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)

Secondary Outcome Measures

Change in proportion of eligible patients who completed out-of-office BP testing during maintenance period [24 months]
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)
Change in proportion of scheduled clinic visits with appropriate out-of-office BP test ordering post-implementation [12 months]
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)
Change in proportion of scheduled clinic visits with appropriate out-of-office BP test ordering during maintenance period [24 months]
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)
Change in proportion of patients with newly diagnosed white-coat hypertension post-implementation [12 months]
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)
Change in proportion of patients with newly diagnosed white-coat hypertension during maintenance period [24 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)