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临床试验/NCT03926533
NCT03926533已完成不适用

Telehealth-Enhanced Patient-Oriented Recovery Trajectory After Intensive Care Pilot Feasibility Study

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2019年11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
91
试验地点
2
主要终点
Acceptability

研究概览

简要总结

Although more than 50% of survivors of critical illness experience one or more post-intensive care syndrome (PICS) problems, there are still no validated interventions for the management of PICS. The long-term goal of this study is to develop and refine in-person and telehealth strategies for the delivery of Intensive Care Unit (ICU) recovery care for the treatment of PICS.

详细描述

The overall objectives in this application are to (a) examine the feasibility of providing telehealth ICU recovery care and (b) determine if ICU recovery care is effective. The central hypothesis is that ICU recovery care improves cognitive, mental health, and physical function of ICU survivors by application of a patient-centered survivorship care plan with targeted interventions to address patient-specific cognitive, mental health, and physical dysfunctions. The rationale for this project is that a determination of the feasibility of telehealth and effectiveness of ICU recovery care in general is likely to offer a strong scientific framework informing the development of new implementation strategies. We will test the central hypotheses by pursuing two specific aims: 1) Test that telehealth ICU recovery care is feasible, and 2) Test the hypothesis that telehealth ICU recovery care compared to standard of care conditions will be more effective for improvement in cognitive, mental health, physical, and global function at 6 months following hospital discharge. To address these aims, we will enroll patients treated for septic shock and acute respiratory distress syndrome in the medical and surgical ICUs at Vanderbilt University Medical Center. Study patients will be randomized 1:1 to either the telehealth ICU recovery care or standard of care groups. We will conduct telehealth ICU recovery care from the Vanderbilt ICU Recovery Center. This ICU survivor clinic relies on the expertise of clinicians from critical care medicine, nursing, pharmacy, neuropsychology, rehabilitation, and case management to assess and manage PICS. Telehealth feasibility measures include appropriateness, acceptability, and implementability. Following telehealth clinic participation at 3 weeks and 3 months after hospital discharge, we will assess participants for cognitive, mental health, physical, and global quality of life outcomes using trained, blinded research personnel at 6 months following hospital discharge. We incorporated PROMIS patient-centered outcome measures into each patient outcome category. This research is significant because it is expected to provide scientific justification for the continued development and implementation of ICU recovery care programs. Ultimately, such knowledge has the potential to improve the quality of life for millions of ICU survivors and their family members.

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 (Outcomes Assessor)

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

  • index ICU stay with a diagnosis of sepsis or acute respiratory distress syndrome projected to be discharged alive as these patients are at the highest risk for developing PICS

排除标准

  • no access to computer, electronic device (e.g., tablet, smartphone), and/or internet connection for virtual clinic visit,
  • primary care received outside of VUMC network,
  • hospice care at discharge,
  • substance abuse or psychiatric disorder that prevents independent living,
  • blind, deaf, unable to speak English, or
  • severe dementia prior to index hospitalization

结局指标

主要结局

Acceptability

时间窗: 6 months

participants will complete the 4-item Likert response Acceptability of Intervention Measure (AIM) of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater acceptability. Scores are based on calculated mean.

participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM)

时间窗: 6 months

participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM) of perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater feasibility. Scores are based on calculated mean.

Appropriateness

时间窗: 6 months

participants will complete the 4-item Likert response Intervention Appropriateness Measure (IAM) of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely Disagree = 1 Completely Agree = 5 ). Higher scores indicate greater appropriateness. Scores are based on calculated mean.

次要结局

  • PTSD symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5)(6 months)
  • cognitive impairment(6 months)
  • QOL(6 months)
  • depression(6 months)
  • physical impairments(6 months)
  • anxiety(6 months)

研究者

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

Leanne M Boehm

Assistant Professor

Vanderbilt University

研究点 (2)

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