Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (Hyperlink)
2017年3月15日 更新者:HealthPartners Institute
In this project we develop and implement an intervention to improve hypertension control in a primary care setting that takes advantage of new technology (home blood pressure telemonitoring) and team models of care (pharmacist case management).
The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.
研究概览
详细说明
Blood pressure (BP) is controlled to recommended levels in only 1 in 3 people with hypertension, and there has been little improvement since the late 1980s, despite advances in evidence to support aggressive hypertension control, and availability of many new and effective antihypertensive drugs.
It is clear that meaningful and sustained improvement in hypertension control will likely require fundamental changes in the current physician-centered office-visit based model of caring for hypertension.
In this project we develop and implement an intervention that takes advantage of new technology and team models of care to improve BP measurement and control, solving the problems that have limited the application of case management approaches to hypertension care improvement.
The study will take place in a diverse population of adults with hypertension cared for in a real-world primary care setting.
The Telemonitoring Intervention (TI) integrates 2 innovative components: First, home BP measures are done using state-of-the-art modem-enabled automated equipment that internally stores and electronically transmits BP data through a simple touch-tone telephone connection to a secure web site.
Second, a pharmacist case manager integrated with the primary care team through a jointly used electronic medical record (EMR) and formulary adjusts antihypertensive therapy using an approved written protocol, under a collaborative practice agreement with physicians.
Treatment decisions are based on home BP data and are discussed and communicated to patients in telephone visits with the pharmacist case manager.
Two-way communication between the pharmacist case manager and the patient's primary care team is assured by using a shared EMR and by additional secure messaging of the results of every pharmacist encounter to the primary care team.
To assess the impact of the TI on hypertension control, patient satisfaction, and costs of care, we will conduct a cluster-randomized trial, assigning 16 primary care clinics and 450 of their nested patients with uncontrolled hypertension to either a Usual Care (UC) control group or TI.
Blood pressure outcomes in both groups will be determined at baseline, 6, 12, 18 and 54 months in an identical and blinded fashion in a research clinic separate from the clinical setting where patients received their medical care.
We hypothesize that guideline BP control will be achieved at 6 months and maintained at 12 months in more than 60% of patients from TI clinics, compared to < 40% in patients from UC clinics.
We will compare satisfaction with care and costs in the TI and UC groups.
The TI has the potential to improve hypertension control for millions of patients, and could be implemented widely in diverse and large patient populations based on performance in this randomized trial.
The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.
研究类型
介入性
注册 (实际的)
450
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55440
- HealthPartners Institute
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 21 years or more
- Linked using EMR data to a HealthPartners Medical Group primary care clinic
- Within the 12-month period of time prior to screening have had at least 2 primary care outpatient encounters, in the two most recent of which the blood pressure was above Joint National Committee 7 (JNC7) goal (<140/90 mmHg or <130/80 for patients with diabetes or kidney disease).
- Have a measured blood pressure at a research clinic screening visit above the JNC7 goal
Exclusion Criteria:
- Acute coronary syndrome or stroke within the past 3 months
- Class III (marked limitation of physical activity) or IV (symptoms at rest) New York Heart Association heart failure, or known left ventricular ejection fraction (<30%)
- Severe renal dysfunction, with epidermal growth factor receptor (eGFR) ,30 ml/min/1.73 m2 using the abbreviated Modification of Diet in Renal Disease Study (MDRD) equation
- Known secondary causes of hypertension such as coarctation of the aorta, pheochromocytoma, adrenal cortical hypertension or renal vascular hypertension
- Unwillingness to be followed for a period of 18 months
- Pregnancy or unwillingness to use reliable bith control for females of child-bearing age
- Participation in another clinical trial
- Requires an interpreter to communicate with health care providers
- Dementia, mental illness or any condition that would limit ability to give informed consent
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Control
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
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实验性的:Telemonitors and pharmacy management
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure.
Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
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Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Blood Pressure Control
大体时间:Baseline, 6 months, 12 months, 18 months
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Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)
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Baseline, 6 months, 12 months, 18 months
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Mean Systolic Blood Pressure
大体时间:Baseline, 6 months, 12 months, 18 months, 54 months
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Systolic blood pressure at baseline and 4 time points
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Baseline, 6 months, 12 months, 18 months, 54 months
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Mean Diastolic Blood Pressure
大体时间:Baseline, 6 months, 12 months, 18 months, 54 months
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Mean diastolic blood pressure at baseline and 4 time points
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Baseline, 6 months, 12 months, 18 months, 54 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Karen L Margolis, MD, MPH、HealthPartners Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Margolis KL, Crain AL, Green BB, O'Connor PJ, Solberg LI, Beran M, Bergdall AR, Pawloski PA, Ziegenfuss JY, JaKa MM, Appana D, Sharma R, Kodet AJ, Trower NK, Rehrauer DJ, McKinney Z, Norton CK, Haugen P, Anderson JP, Crabtree BF, Norman SK, Sperl-Hillen JM. Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence. Trials. 2022 Aug 17;23(1):673. doi: 10.1186/s13063-022-06611-3.
- Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Maciosek MV, Nyboer RA, O'Connor PJ, Pawloski PA, Sperl-Hillen JM, Trower NK, Tucker AD, Green BB. A Successful Multifaceted Trial to Improve Hypertension Control in Primary Care: Why Did it Work? J Gen Intern Med. 2015 Nov;30(11):1665-72. doi: 10.1007/s11606-015-3355-x.
- Margolis KL, Kerby TJ, Asche SE, Bergdall AR, Maciosek MV, O'Connor PJ, Sperl-Hillen JM. Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial. Contemp Clin Trials. 2012 Jul;33(4):794-803. doi: 10.1016/j.cct.2012.03.014. Epub 2012 Apr 1.
- Pawloski PA, Asche SE, Trower NK, Bergdall AR, Dehmer SP, Maciosek MV, Nyboer RA, O'Connor PJ, Sperl-Hillen JM, Green BB, Margolis KL. A substudy evaluating treatment intensification on medication adherence among hypertensive patients receiving home blood pressure telemonitoring and pharmacist management. J Clin Pharm Ther. 2016 Oct;41(5):493-8. doi: 10.1111/jcpt.12414. Epub 2016 Jun 30.
- Asche SE, O'Connor PJ, Dehmer SP, Green BB, Bergdall AR, Maciosek MV, Nyboer RA, Pawloski PA, Sperl-Hillen JM, Trower NK, Margolis KL. Patient characteristics associated with greater blood pressure control in a randomized trial of home blood pressure telemonitoring and pharmacist management. J Am Soc Hypertens. 2016 Nov;10(11):873-880. doi: 10.1016/j.jash.2016.09.004. Epub 2016 Sep 25.
- Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549.
- Kerby TJ, Asche SE, Maciosek MV, O'Connor PJ, Sperl-Hillen JM, Margolis KL. Adherence to blood pressure telemonitoring in a cluster-randomized clinical trial. J Clin Hypertens (Greenwich). 2012 Oct;14(10):668-74. doi: 10.1111/j.1751-7176.2012.00685.x. Epub 2012 Jul 26.
- Margolis KL, Dehmer SP, Sperl-Hillen J, O'Connor PJ, Asche SE, Bergdall AR, Green BB, Nyboer RA, Pawloski PA, Trower NK, Maciosek MV. Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension. Hypertension. 2020 Oct;76(4):1097-1103. doi: 10.1161/HYPERTENSIONAHA.120.15492. Epub 2020 Aug 31.
- Margolis KL, Asche SE, Dehmer SP, Bergdall AR, Green BB, Sperl-Hillen JM, Nyboer RA, Pawloski PA, Maciosek MV, Trower NK, O'Connor PJ. Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension: Follow-up of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e181617. doi: 10.1001/jamanetworkopen.2018.1617.
- Annuzzi G, Bozzetto L, Costabile G, Giacco R, Mangione A, Anniballi G, Vitale M, Vetrani C, Cipriano P, Della Corte G, Pasanisi F, Riccardi G, Rivellese AA. Diets naturally rich in polyphenols improve fasting and postprandial dyslipidemia and reduce oxidative stress: a randomized controlled trial. Am J Clin Nutr. 2014 Mar;99(3):463-71. doi: 10.3945/ajcn.113.073445. Epub 2013 Dec 24.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年3月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2008年10月28日
首先提交符合 QC 标准的
2008年10月28日
首次发布 (估计)
2008年10月29日
研究记录更新
最后更新发布 (实际的)
2017年4月13日
上次提交的符合 QC 标准的更新
2017年3月15日
最后验证
2017年3月1日
更多信息
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