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Implementing Hypertension Screening Guidelines in Primary Care

Primary Purpose

Hypertension,Essential, White Coat Hypertension

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multifaceted Implementation Strategy
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension,Essential focused on measuring hypertension, screening, guidelines, implementation, randomized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

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

Sites / Locations

  • Center for Behavioral Cardiovascular Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multifaceted Implementation Strategy

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
March 21, 2018
Last Updated
March 7, 2022
Sponsor
Columbia University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT03480217
Brief Title
Implementing Hypertension Screening Guidelines in Primary Care
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential, White Coat Hypertension
Keywords
hypertension, screening, guidelines, implementation, randomized

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifaceted Implementation Strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted Implementation Strategy
Intervention Description
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 Outcome Measure Information:
Title
Change in proportion of eligible patients who completed out-of-office BP testing post-implementation
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in proportion of eligible patients who completed out-of-office BP testing during maintenance period
Description
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)
Time Frame
24 months
Title
Change in proportion of scheduled clinic visits with appropriate out-of-office BP test ordering post-implementation
Description
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)
Time Frame
12 months
Title
Change in proportion of scheduled clinic visits with appropriate out-of-office BP test ordering during maintenance period
Description
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)
Time Frame
24 months
Title
Change in proportion of patients with newly diagnosed white-coat hypertension post-implementation
Description
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)
Time Frame
12 months
Title
Change in proportion of patients with newly diagnosed white-coat hypertension during maintenance period
Description
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)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Kronish, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Behavioral Cardiovascular Health
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigator plans to make available upon request a de-identified database that includes clinic BP readings and demographic and comorbidity characteristics of patients in this study.
IPD Sharing Time Frame
Within 1 year of completion of trial
IPD Sharing Access Criteria
De-identified database will include clinic BP readings, demographic and comorbidity characteristics of patients.
Citations:
PubMed Identifier
26458123
Citation
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.
Results Reference
background
PubMed Identifier
28734798
Citation
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.
Results Reference
background
PubMed Identifier
25531400
Citation
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.
Results Reference
background
PubMed Identifier
32771002
Citation
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.
Results Reference
background
PubMed Identifier
29788130
Citation
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.
Results Reference
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Implementing Hypertension Screening Guidelines in Primary Care

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