跳至主要内容
临床试验/NCT04603560
NCT04603560已完成不适用

Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 511 人开始时间: 2021年10月26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
511
试验地点
1
主要终点
Treatment Intensification

研究概览

简要总结

This is a three-arm pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness. Study investigators will use EHR data to identify providers of patients whose hypertension treatment was not intensified. Primary care physicians will then be randomized to one of three arms: pharmacist e-detailing, provider dashboards, or no intervention (control). After the intervention, the investigators will conduct virtual interviews with select providers from each arm. A predictive modeling approach will then be used to identify patient and provider characteristics that are associated with inertia and with responsiveness to each intervention.

详细描述

We propose a pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness.

For Aim 1, we will use Electronic Health Record (EHR) data to identify physicians of patients whose hypertension treatment was not intensified despite their having persistently elevated blood pressure. We will then randomize primary care physicians to on of three arms: academic e-detailing, social norming, or no intervention (control).

For Aim 2, we will conduct interviews with select physicians from each arm. We will then identify patient and physician characteristics that are associated with inertia and with responsiveness to each intervention.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Provider Inclusion Criteria:
  • •Primary care physician
  • •Practicing in primary care at Massachusetts General Hospital
  • •Caring for at least 2 patients: (1) aged 18-79, (2) for whom the recent BP history in the last 18 months is above goal, (3) whose most recent BP at an outpatient visit was above goal, and (4) who did not have their hypertension treatment regimens intensified (dose increase, new medication, or medication exchange) at or since that time. The BP goal will be <140/90 for all patients. To accommodate changes in care delivery that occurred during the COVID surge, outpatient visits will include in-office and virtual visits that had vitals recorded in the EHR the same day.

排除标准

  • •fewer than 100 patients on their primary care panel
  • •practice less than one session per week
  • •Patient Inclusion Criteria:
  • •had a blood pressure greater than 140/90 mmHg at 2+ PCP visits in the past 12 months
  • •treatment was not intensified at any of these visits
  • •Patient Exclusion Criteria:
  • •excluded from the hypertension registry
  • •currently pregnant or post-partum 6 months
  • •receiving hospice care

研究组 & 干预措施

Audit and Feedback

Experimental

A report of the provider's hypertension control rates compared to benchmark will be displayed using principles of social norming. We will present that provider's hypertension control rates compared to the 90th percentile of their peers.

干预措施: Audit and Feedback (Behavioral)

Pharmacist E-Detailing

Experimental

A pharmacist will review the chart in advance and provide a personalized recommendation for how to intensify the specific patient's antihypertensive regimen based on current guidelines. For example, they might recommend adding an additional medication based on the patient's comorbid conditions and could suggest a starting dose and timeframe for dose escalation.

干预措施: Pharmacist E-Detailing (Behavioral)

Control

No Intervention

No intervention will be provided to physicians in the control arm.

结局指标

主要结局

Treatment Intensification

时间窗: During the primary care office visit in which the provider-patient dyad received the intervention

The primary outcome was whether physicians intensified treatment at the target visit. Intensification was defined as adding a new antihypertensive medication or increasing the total daily dose of an existing one. This was measured by identifying all prescriptions for anti-hypertensive medications in the electronic health record (EHR) on the day of the target visit and comparing the medication name and total daily dose to anti-hypertensive medications prescribed prior to the target visit date, following the same procedure used to identify intensification during the eligibility assessment

次要结局

未报告次要终点

研究者

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

Nancy Haff, MD, MPH

Associate Epidemiologist, Division of Pharmacoepidemiology

Brigham and Women's Hospital

研究点 (1)

Loading locations...

相似试验