跳至主要内容
临床试验/NCT03480217
NCT03480217已完成不适用

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

Columbia University2 个研究点 分布在 1 个国家目标入组 1,186 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,186
试验地点
2
主要终点
Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •(as per electronic medical records):
  • •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)
  • •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

研究组 & 干预措施

Intervention Clinics, Pre-Implementation

Experimental

Usual care

干预措施: Usual care (Other)

Intervention Clinics, Post-Implementation

Experimental

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.

干预措施: Multifaceted Implementation Strategy (Behavioral)

Control Clinics, Pre-Implementation

Other

Usual care

干预措施: Usual care (Other)

Control Clinics, Post-Implementation

Other

Usual care

干预措施: Usual care (Other)

结局指标

主要结局

Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period

时间窗: 6 months (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.

Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Post-Implementation Period

时间窗: 6 months (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.

次要结局

  • Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Pre-Implementation Period(6 months (Pre-Implementation period))
  • Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Post-Implementation Period(6 months (Post-Implementation period))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ian Kronish

Florence Irving Associate Professor of Medicine

Columbia University

研究点 (2)

Loading locations...

相似试验