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临床试验/NCT03713333
NCT03713333已完成不适用

Implementation of High Definition Screening Using Handheld Imaging and Digital Health Technologies Within a Learning Health System to Identify Cardiovascular Disease at the Point-of-care: The ASE-INNOVATE Program

Scripps Health2 个研究点 分布在 1 个国家目标入组 374 人开始时间: 2018年10月20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
374
试验地点
2
主要终点
Health Economic Outcomes

研究概览

简要总结

The need for new models of integrated care that can improve the efficiency of healthcare and reduce the costs are key priorities for health systems across the United States. Treatment costs for patients with at least one chronic medical or cardiovascular condition make up over 4-trillion dollars in spending on healthcare, with estimations of a population prevalence of 100-million affected individuals within the next decade. Therefore, the management of chronic conditions requires innovative and new implementation methods that improve outcomes, reduce costs, and increase healthcare efficiencies. Digital health, the use of mobile computing and communication technologies as an integral new models of care is seen as one potential solution. Despite the potential applications, there is limited data to support that new technologies improve healthcare outcomes. To do so requires; 1) robust methods to determine the impact of new technologies on healthcare outcomes and costs; and 2) evaluative mechanisms for how new devices are integrated into patient care. In this regard, the proposed clinical trial aims to advance the investigator's knowledge and to demonstrate the pragmatic utilization of new technologies within a learning healthcare system providing services to high-risk patient populations.

详细描述

Objective #1: Determine the effectiveness of handheld imaging and digital health devices on long term health and patient-reported outcomes through pragmatic and randomized clinical trial designs.

Objective #2: Assess the impact of digital health devices and remote patient monitoring (RPM) on measures of healthcare efficiency. Measures of healthcare efficiency directly related to digital health technologies and RPM include: identify which interventions can improve care; define the variations in care and; demonstrate within which patient populations digital health technologies are most effective.

Objective #3: Apply integration methods for handheld imaging and digital health devices used for clinical decisions.

Achieving integration and interoperability-the ability of different information technology systems and software applications to communicate and exchange data with each other-requires identification for precisely how new innovations merge into systems of care and are applied to various practice settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Screening
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Treating physicians and clinical practitioners will not be concealed to the randomized allocation of individual clinics or the patients that are seen in these encounters. Physicians in the interventional group will participate in conducting technology-enabled visitations before and after a patient encounter and therefore are not blinded to the assessment. For the standard care group handheld imaging and remote patient monitoring will not be performed after the patient-physician encounter. Principal investigators, outcome adjudicators, and statisticians are blinded to randomization, device findings, and treatment decisions.

入排标准

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

入选标准

  • All participants of the ASE 2018 Outreach Event who are at least 18 years old who are referred for a cardiac evaluation

排除标准

  • Those not willing to consent

结局指标

主要结局

Health Economic Outcomes

时间窗: 180 days

Economic difference between the total costs of care between randomized arms including; clinic visitations, hospitalizations, emergency room visitations, and diagnostic testing. Collected as cumulative diagnosis-related group (DRG) and current procedural terminology (CPT) amounts in United States Dollars

次要结局

  • Patient-Reported Experience Measures(180 days)
  • Mobile Cardiac Telemetry(180 days)
  • Patient-Reported Outcome Measures(180 days)
  • Health Economic Outcomes(30 days)
  • Heart Failure(180 days)
  • Atrial Fibrillation(180 days)
  • Diagnostic Imaging(180 days)
  • Emergency Department Visitations(180 days)
  • Hospitalization(180 days)
  • Clinic Visitations(180 days)
  • Medical Therapy(180 days)

研究者

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

Sanjeev Bhavnani MD

Principal Investigator - Healthcare Innovation

Scripps Health

研究点 (2)

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