跳至主要内容
临床试验/NCT06124716
NCT06124716进行中(未招募)不适用

Collaboration Oriented Approach to Controlling High Blood Pressure

Oregon Health and Science University3 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2024年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
550
试验地点
3
主要终点
Blood Pressure Control

研究概览

简要总结

Hypertension is a significant contributor to poor cardiovascular outcomes. Self-management support tools can increase patient behaviors to improve blood pressure. The investigators created a clinical decision support app, called COACH, to integrate home blood pressure data and goals into EHR reporting and workflow with communications informed by behavioral economics principles to support shared decision-making. The study aims to measure the effectiveness of the COACH intervention in a pragmatic multi-site randomized trial in a primary care setting.

详细描述

This protocol addresses the challenge of implementing scalable, interoperable clinical decision support (CDS) and the patient-centered outcome of avoiding heart attacks and strokes through high blood pressure control in the setting of multiple chronic illnesses. It leverages substantial extant work to build patient-centered CDS for high blood pressure, electronic care planning and health coaching at scale, implementing and testing these tools in new primary care settings. This protocol implements a new patient-facing CDS across multiple clinic sites spanning three major health systems and in the nation's two leading EHR vendor platforms. Controlling blood pressure is a singularly important goal; nearly 50% of adults in health care have high blood pressure, which increases their risk of heart attack and stroke. However, managing blood pressure requires navigation within a narrow therapeutic index, where overtreatment leads to substantial complications, including kidney damage, low blood pressure, falls, and mood disorders. Balancing treatment to reduce risk while avoiding harm requires engaging patients directly in intensive goal setting, shared care planning around nonpharmacologic and pharmacologic treatments, and self-monitoring for effectiveness and adverse events.

Hypertension rarely occurs alone; providing clinical decision support, care planning, and self-management support in the context of multiple chronic illnesses is required.

The study team will address patient-centered needs by scaling our implemented, patient-facing CDS for eCare Planning, Collaboration Oriented Approach to Controlling High blood pressure (COACH) to 3 sites and testing whether it reduces blood pressure and risk of heart attack and stroke. To do so, we embed a diverse patient perspective into a robust, feasible, and effective CDS implementation and evaluation process by 1) capturing patient input throughout the CDS lifecycle; 2) adapting the COACH CDS to patient preferences, values, and goals; and 3) disseminating the tested FHIR-based (Fast Healthcare Interoperability Resources) patient-facing application into organizations that combines blood pressure control with relevant risk scores into an eCare Plan application and framework and implementing these patient-centered approaches in feasible, context-responsive, and effective ways. The investigators address scalability by helping organizations advance their use of patient-generated health data and patient-reported outcomes using standard implementation frameworks while producing CDS artifacts and implementation guides that can be leveraged to increase adoption beyond the work of this proposal. For interoperability, we use a standard-based, structured process that re-uses concept and value sets whenever possible while using robust techniques to develop new sets and make them available for future innovators.

To complete these goals, the study investigators leverage previous work in building standardized HBP value sets, logic, and a patient-facing FHIR tool. In this work, we have engaged in several collaborations, most notably with the CDS Connect Community, where we will upload all artifacts, but also with other AHRQ digital health efforts and with other large collaboratives, including the ACC/AHA and JNC8 guideline developers, the HL7 CPG-on-FHIR, and the eCare Planning project from NIDDK and AHRQ. The study investigators will use two frameworks to evaluate the implementation. First, adaptation in implementation science is both common and may be required for success; we explore the ways in which the 5 rights-the right information to the right person in the right intervention format through the right channel at the right time in workflow-can be adapted for key organizational needs while retaining fidelity to the goals. In addition, we consider a framework that combines usability with effectiveness for complex conditions by exploring concepts related to appropriate simplicity, prioritization, summarization, adjudication, and actionability to enhance CDS effectiveness for patient needs.

Thus, the study's specific aims are:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Statisticians and investigators will be blinded to allocation status. Study participants will be informed that the study is testing the effectiveness of a home BP monitoring program, but not that the study is comparing two models of care.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18-100 years old
  • Patient receives care at a participating primary care clinic and has been seen in the last year
  • Patient has high BP, defined as an average of 4 BPs > 140 systolic or > 90 diastolic (clinic) or > 135 OR > 85 (home)
  • Patient is enrolled in online health portal
  • Patient can communicate in English
  • Patient has been recommended by their physician who thinks the patient would benefit from a home blood pressure monitoring program.

排除标准

  • Patient is pregnant at the time of consent
  • Patient who, in the opinion of the primary care clinician, has severe cognitive impairment
  • Patient is on hospice care and/or has a life expectancy of less than 2 years
  • Patient has end stage renal disease
  • Patient for whom tight blood pressure control presents a greater risk, such as those with a history of adverse events from hypertension treatment (falls, dizziness, electrolyte disturbances, hypotension, active heart failure)
  • Patient has any other disease or disorder that in the opinion of the investigator or the patient's primary care clinician, could put participants at risk and affect trial results, or hinder participation will exclude them from participating

研究组 & 干预措施

Enhanced COACH

Experimental

Enhanced blood pressure management recommendations that use cognitive and behavioral science to increase the likelihood of self-management goal setting to lower blood pressure. The CDS tool allows participant access to BP visualizations, reminders, and affectively tailored messaging about blood pressure management.

干预措施: Enhanced COACH CDS Tool (Other)

Usual Care COACH

Active Comparator

Equivalent of usual care delivered through the CDS tool: Blood pressure management with basic information, reduced reminders, and no affective alerts.

干预措施: Usual Care COACH CDS Tool (Other)

结局指标

主要结局

Blood Pressure Control

时间窗: Up to 6 months

Percent of participants at or below 140/90 (office BP) or 135/85 (home BP) average.

次要结局

  • Reduction in Systolic and/or Diastolic Blood Pressure(Up to 6 months)
  • Demographic factors contributing to blood pressure control(Up to 6 months)
  • COACH Application System Usability Evaluation(Up to 6 months)
  • Participant report of health behaviors including Self Efficacy, Social Support, Outcome Expectations and Self-regulation(2 months, 6 months)

研究者

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

David Dorr

Principal Investigator

Oregon Health and Science University

研究点 (3)

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