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临床试验/NCT03386773
NCT03386773已完成不适用

Engaging Disadvantaged Patients in Sharing Patient Generated Health Data and Patient Reported Outcomes Through Health Information Technology

Denver Health and Hospital Authority2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年11月2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
300
试验地点
2
主要终点
Patient Engagement (Patient Activation Measure)

研究概览

简要总结

This study will assess the feasibility of using patient-centered, commercial off-the-shelf (COTS) health information technology (IT) solutions to collect patient generated health data (PGHD) and patient-reported outcomes (PROs) from diverse, low-income disadvantaged populations. These data will then be mapped and reported in a way that will allow them to be made actionable and used to improve health care quality and delivery. The data mapping will be designed for data collection through technology such as mobile apps and wearables, and will be intended to support integration into interoperable electronic health records (EHRs), clinical information systems, and big data infrastructures.

详细描述

Patient engagement is particularly critical to achieving good chronic disease self-management. This is especially important for disadvantaged patients, who are disproportionately affected by chronic disease. A key component of chronic disease self-management is the ability for patients to record and monitor their ongoing performance on indicator measures. While health IT solutions have been shown to improve chronic disease self-management, adoption and use of costly, specialized technologies among disadvantaged patients is lower than among higher-income populations. In contrast, COTS technologies such as mobile phones are more accessible to and widely adopted by disadvantaged patients, thus bridging the gap of the digital divide.

The central research hypothesis posits that 1) low-income, disadvantaged patients both can and will provide high quality PGHD and PROs through COTS-based health IT solutions, and 2) these data can be integrated into clinical systems and used to improve health care quality and delivery. PGHD can be collected through patient interaction with COTS health IT solutions such as mobile health apps and fitness trackers. PROs can be collected via patient response to questionnaire-based PROs measures, or PROMs. These data can be transmitted to clinical information systems, integrated into clinical workflows and used by providers to improve health care quality and delivery. Using a sequential integrated mixed-methods approach, we propose to test the central hypothesis through three specific aims, as follows:

Aim 1: To assess the needs and preferences of disadvantaged patients and safety net health care providers regarding the use of health IT for communicating PGHD and PROs.

Aim 1 Research Questions: What specific features in COTS solutions meet the needs and preferences of disadvantaged patients for communicating PGHD and PROs to their providers? What PGHD and PROs are deemed most important by providers and patients for improving health care and health outcomes?

Answering these questions will inform health IT solution selection, design, usability, and utility; assist with prioritizing PGHD and PROs collection by data element and measure type; and identify potential discrepancies between patients' and providers' perceptions of PGHD and PROs importance.

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
None

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

  • BMI of 25.0-39.9,
  • Has a smartphone
  • English or Spanish as primary language
  • assessed at "medium health risk" according a risk stratification algorithm based on clinical criteria, diagnostic scoring, and health care utilization

排除标准

  • Does not meet inclusion criteria

结局指标

主要结局

Patient Engagement (Patient Activation Measure)

时间窗: Baseline, Post-Intervention

Patient Engagement will be measured by participant performance on the Patient Activation Measurement (PAM)-13 tool. This validated instrument helps to show patients' motivation for being an active participant in managing their health. Each of the 13 items on the tool is rated on a four-point per-item scale, then converted to a total PAM score. The total PAM score is transformed into a scale score with values that range from 0 to 100 based on the calibration tables for the instrument, with higher numbers reflecting better scores and indicative of increased engagement. The scale score is reported here.

次要结局

  • Healthy Days HRQOL-4 Measure(16 weeks)
  • Healthy Days Symptoms Measure(16 weeks)
  • Weight Loss(16 weeks)
  • Number of Patients Who Responded to Text Messages(16 weeks)

研究者

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

Susan Moore

Associate Director, mHealth Impact Lab

Colorado School of Public Health

研究点 (2)

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