An interventional study of Multifaceted Implementation Strategy and Usual care in Hypertension,Essential and White Coat Hypertension, sponsored by Columbia University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
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):
Patient Exclusion Criteria (as per electronic medical records):
Clinic Inclusion Criteria:
Clinic Exclusion Criteria:
Usual care
Other: Usual care
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
Usual care
Other: Usual care
Usual care
Other: Usual care
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
Primary care clinicians diagnose hypertension according to usual care
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.
Time frame: 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.
Time frame: 6 months (Post-Implementation period)
Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Pre-Implementation Period
Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.
Time frame: 6 months (Pre-Implementation period)
Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Post-Implementation Period
Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.
Time frame: 6 months (Post-Implementation period)
Patients were passively recruited from the electronic health record.
| Milestone | Intervention Clinics | Control (Usual Care) Clinics |
|---|---|---|
| Started | 456 | 139 |
| Completed | 456 | 139 |
| Not completed | 0 | 0 |
| Milestone | Intervention Clinics | Control (Usual Care) Clinics |
|---|---|---|
| Started | 401 | 190 |
| Completed | 401 | 190 |
| Not completed | 0 | 0 |
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.
| percentage of visits | Intervention Clinics | Control Clinics |
|---|---|---|
| Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period | 0.6 | 5.4 |
Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.
| percentage of visits | Intervention Clinics | Control Clinics |
|---|---|---|
| Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Pre-Implementation Period | 2.8 | 8.7 |
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.
| percentage of visits | Intervention Clinics | Control Clinics |
|---|---|---|
| Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Post-Implementation Period | 5.7 | 4.3 |
Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.
| percentage of visits | Intervention Clinics | Control Clinics |
|---|---|---|
| Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Post-Implementation Period | 7.9 | 9.2 |
Collected over Adverse event data were recorded up to 6 months after the 12-month pre-implementation and 12-month post-implementation periods.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Clinics | 0/857 (0%) | 0/857 (0%) | 0/857 (0%) |
| Control Clinics | 0/329 (0%) | 0/329 (0%) | 0/329 (0%) |
The clinics are either implementing the intervention (4 out of 8) or providing usual care (4 out of 8) after the implementation period begins. The baseline analysis for the participants that visited these clinics are calculated separately - those who visited the Intervention Clinics before and after the implementation (456+401=857 total) and those who visited the Control Clinics before and after the implementation (139+190=329 total).
| Age, Continuous(years) | Intervention Clinics (Pre-Implementation) | Intervention Clinics (Post-Implementation) | Control (Usual Care) Clinics (Pre-Implementation) | Control (Usual Care) Clinics (Post-Implementation) | Total |
|---|---|---|---|---|---|
| Mean | 51.6 ± 14.1 | 51.3 ± 14.5 | 58.9 ± 16.0 | 59.8 ± 19.1 | 53.6 ± 15.7 |
| Sex: Female, Male(Participants) | Intervention Clinics (Pre-Implementation) | Intervention Clinics (Post-Implementation) | Control (Usual Care) Clinics (Pre-Implementation) | Control (Usual Care) Clinics (Post-Implementation) | Total |
|---|---|---|---|---|---|
| Female | 289 | 257 | 105 | 157 | 808 |
| Male | 167 | 144 | 34 | 33 | 378 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Clinics (Pre-Implementation) | Intervention Clinics (Post-Implementation) | Control (Usual Care) Clinics (Pre-Implementation) | Control (Usual Care) Clinics (Post-Implementation) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 152 | 113 | 50 | 53 | 368 |
| Not Hispanic or Latino | 70 | 79 | 17 | 43 | 209 |
| Unknown or Not Reported | 234 | 209 | 72 | 94 | 609 |
| Race (NIH/OMB)(Participants) | Intervention Clinics (Pre-Implementation) | Intervention Clinics (Post-Implementation) | Control (Usual Care) Clinics (Pre-Implementation) | Control (Usual Care) Clinics (Post-Implementation) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 53 | 50 | 9 | 11 | 123 |
| White | 86 | 69 | 33 | 57 | 245 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 317 | 282 | 97 | 122 | 818 |
| Region of Enrollment(participants) | Intervention Clinics (Pre-Implementation) | Intervention Clinics (Post-Implementation) | Control (Usual Care) Clinics (Pre-Implementation) | Control (Usual Care) Clinics (Post-Implementation) | Total |
|---|---|---|---|---|---|
| United States | 456 | 401 | 139 | 190 | 1186 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A de-identified data archive that contains raw study data will be posted on an open science platform.
Supporting information: Study protocol, Sap, Analytic code
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