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临床试验/NCT02632552
NCT02632552已完成不适用

A Technology-Assisted Care Transition Intervention for Veterans With Chronic Heart Failure or Chronic Obstructive Pulmonary Disease

VA Office of Research and Development10 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年5月1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
140
试验地点
10
主要终点
Pre-post Change in Combined Emergency and Urgent Care Service Utilization

研究概览

简要总结

Transition from hospital to home places patients in jeopardy of adverse events and increases their risk for rehospitalization. CHF is the most prevalent chronic condition among U.S. adults and COPD is the third leading cause of death in the U.S. Both CHF and COPD represent significant burdens for the VHA healthcare system. Care transitions can be supported through multi-component interventions, but are costly to implement. Virtual nurses provide an effective medium for explaining health concepts to patients, and previous work indicates patients find virtual nurses acceptable. The investigators will implement and evaluate a virtual nurse intervention to provide automated, tailored, and timely support to Veterans transitioning from hospital to home. As effective care transition interventions incorporate both inpatient and outpatient components, the virtual nurse will first engage with patient onscreen during their inpatient stay and then via text message post-discharge. This project has the potential to improve the care transition experience for patients, caregivers and healthcare providers.

详细描述

The last decade has seen a steady increase in the resources that VHA uses to treat chronic heart failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD), both of which are among the most common reasons for admission and re-admission in VHA facilities. Multi-component care transition interventions can be effective, but are costly. One approach to reduce complexity and costs is to offload some work to technology.

Informed by the sociotechnical model, this study proposes a technology-assisted care transition intervention founded on the concept of a virtual nurse that interacts with Veterans through different technology channels. The virtual nurse is an anthropomorphized computer program designed to simulate a discharge nurse. During the inpatient stay, the virtual nurse will appear on a computer touch screen and will educate Veterans with CHF or COPD about the important components of a care transition (drawing on the Coleman Care Transition Model) as well as how to send and receive text messages on their mobile phone. Following discharge to home, the virtual nurse will continue to coach Veterans and their family members and improve post-discharge access to care through two-way computer-tailored text messaging made possible by VHA's new HealtheDialog system. Specific aims are to:

  1. Refine methods and collect formative measures to guide implementation
  2. Conduct a randomized trial of the technology-assisted care transition intervention
  3. Evaluate the intervention, including its effectiveness, implementation, and budget impact

The investigators propose a mixed methods formative assessment and simulation experiment to refine existing technologies to the VA care transition setting (Aim 1). This will be followed by a multi-site randomized type1 hybrid implementation trial (Aims 2 and 3). The trial will evaluate the effectiveness of the virtual nurse intervention in twelve clinical teams and also gather information about its implementation to inform broader rollout.

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
Single (Participant)

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

  • Diagnosis of chronic heart failure or chronic obstructive pulmonary disease
  • Admission to a general medical service
  • Able and willing to engage with touchscreen technology
  • Have a text-enabled cellular phone to receive the post-discharge text messages

排除标准

  • Not Veterans
  • Not diagnosed of chronic heart failure or chronic obstructive pulmonary disease
  • Not admitted to a general medical service
  • Not capable of using touchscreen technology
  • Do not have a text-enabled cellular phone

结局指标

主要结局

Pre-post Change in Combined Emergency and Urgent Care Service Utilization

时间窗: 18 months prior to enrollment and 12 months post-discharge

Comparing Total Number of Combined Emergency and Urgent Care Utilization for Veterans with CHF and/or COPD between Intervention and Control across time. This measure is defined as the total number of VA emergency department visits and VA urgent care visits for each participant during the study period.

次要结局

  • Outcome Measure Title: Self-Care of Heart Failure Index Score Comparison(Baseline and 30-day follow-up)
  • Health Distress Score Comparison(The Health Distress measure was assessed at baseline, 7 days post-discharge, and 30 days post-discharge.)
  • COPD Self-Management Scale Score Comparison(Baseline and 30-day follow-up)
  • Self-Efficacy for Managing Symptoms (PROMIS)(Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up)
  • Self Efficacy for Managing Chronic Disease Scale Comparison(Baseline and 30-day follow-up.)
  • Self-Efficacy for Managing Medications and Treatments (PROMIS)(Enrolled Veterans with CHF and/or COPD who completed baseline and 30-day follow-up.)
  • Care Transition Measure (CTM) Score Comparison(Responses to the CTM were collected from the intervention and control groups 7 days post-discharge.)
  • Adherence to Refills and Medications Scale (ARMS) Score Comparison(ARMS questionnaires were given to all participants at baseline and again at 30-day post-discharge follow-up)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (10)

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