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临床试验/NCT04764318
NCT04764318已完成不适用

A Pilot Study of Hypertension Management Using Remote Patient Monitoring: Study 2

Northwestern University1 个研究点 分布在 1 个国家目标入组 17,290 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17,290
试验地点
1
主要终点
Performance measure Controlling High Blood Pressure (NQF 0018)

研究概览

简要总结

The investigators will conduct a pragmatic pilot test of a remote patient monitoring system (RPM) for blood pressure measurement for Medicare patients with hypertension with and without the support of a care management program. The primary objective is to better understand how patients' remote monitoring of blood pressure and the direct transmission of this data to a healthcare system's EHR can be used by the patient and the care team to support optimal hypertension care and whether the addition of active care management increases the use of RPM and improvements in blood pressure.

This pilot study will be conducted in four Northwestern Medical Group (NMG) primary care practices. Two practices will have RPM available for primary care physicians to order for their eligible Medicare patients and two practices will also receive the support of a care management program to assist with patient enrollment, blood pressure monitoring and taking action in the setting of uncontrolled blood pressure.

The investigators will conduct a pragmatic non-blinded, non-randomized pilot study with contemporaneous controls among NMG outpatient clinics that provide adult primary care. They will make comparisons of data obtained through the course of routine care delivery from pilot and non-pilot practices.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • We will use these criteria to determine which patients will be included or excluded in the study analytic data set.
  • General inclusion criteria:
  • Adults aged 65 to 85 years at the time of the study start date
  • Receive their primary care from an eligible Northwestern Medicine clinic site
  • One or more office or telehealth visits in the year preceding the study start date
  • Inclusion criteria primary population:
  • Last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic
  • Diagnosis of hypertension in the year preceding the study start date (problem list or encounter diagnosis)
  • Inclusion criteria for secondary population
  • Meet criteria for primary population OR
  • Diagnosed hypertension but did not have the last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic OR
  • No diagnosis of hypertension in the past year but did have the last office blood pressure ≥140 mm Hg systolic or ≥90 mmHg diastolic

排除标准

  • Persistent atrial fibrillation as indicated in the electronic health record (EHR)
  • Stage IV or more severe kidney disease, defined as estimated glomerular filtration rate <30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)
  • Diagnosis of dementia as indicated in the electronic health record

结局指标

主要结局

Performance measure Controlling High Blood Pressure (NQF 0018)

时间窗: 3 months

Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period \<140/90 mm Hg, binary

次要结局

  • Systolic blood pressure measured by home readings(3 months)
  • Systolic blood pressure at the most recent office visit(3 months)
  • RPM use(3 months)
  • Remote patient monitoring intensity(3 months)
  • Antihypertensive medication intensification(3 months)
  • RPM BP monitoring uptake(up to 6 months)
  • Controlling high blood pressure--office only(3 months)
  • RPM BP monitoring discontinuation(up to 6 months)

研究者

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

Stephen Persell, MD, MPH

Professor of Medicine

Northwestern University

研究点 (1)

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