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临床试验/NCT06014931
NCT06014931招募中不适用

Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care

Vanderbilt University4 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2024年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
202
试验地点
4
主要终点
Cognitive function - MoCA

研究概览

简要总结

Intact cognitive skills are necessary for independent living, going to work, and managing finances, and any loss of cognitive skills places a burden on society akin to what is seen with Alzheimer's Disease and Related Dementias. The TelePORT Study (Telehealth-Enhanced Patient-Oriented Recovery Trajectories after Intensive Care) is the first post-intensive care syndrome longitudinal long-term cognitive impairment intervention study. The societal effect from long-term cognitive impairment after critical illness is great as many of these patients are employable adults or functional retirees.

详细描述

Up to 80% of Intensive Care Unit (ICU) survivors experience cognitive, physical, mental, and socioeconomic impairments, known as Post-Intensive Care Syndrome (PICS), that can last months to years following critical illness and lead to significant reductions in quality of life. Among historical cohorts of acute respiratory distress syndrome and sepsis survivors, as many as 80% demonstrate PICS-related acquired dementia. Likewise, in a broad group of ICU survivors in all adult age groups, 33% to 50% have acquired dementia. ICU Recovery Clinics (ICU-RC) are a feasible and promising intervention to address multifactorial PICS impairments collaboratively, but in-person access is limited. There is an unmet need to study the efficacy of clinics with large cohorts that apply alternative delivery strategies to enhance availability and reach. Older adult (age >=45) ICU survivor is at a combined risk for long-term cognitive impairment (LTCI) among other PICS impairments, and the ideal population to first address this knowledge gap. The investigators hypothesize that a collaborative telemedicine-delivered interdisciplinary ICU-RC intervention effectively identifies and improves LTCI, physical and mental health dysfunction, social integration, and self-management behaviors vs. a control condition with follow-up chosen by the discharge team. Therefore, in a sample of older septic shock and acute respiratory failure survivors, the investigators aim to examine the efficacy of telemedicine ICU-RC services vs. control follow-up chosen by the discharge team in identifying PICS impairments and improving cognitive, physical, and mental health function; and social integration and self-management behaviors at 6 months after hospital discharge. This willl be achieved via a randomized controlled trial of 202 patients randomized 1:1 with age stratification to telemedicine ICU-RC or control (101 per group). Telemedicine recipients will receive a minimum of 2 ICU-RC visits within 3 months of hospital discharge or return to home if discharged to another institution, with additional follow-up determined by the severity of PICS impairment. Cognitive, mental health, and physical outcomes will be measured using the Long-term Core Outcome Measurement Set for ICU survivors in addition to the Social Network Index and Patient Activation Measure. Measures are timed to assess pre-hospital, 1-week post-discharge, and 6-month post-discharge functioning trajectories. This research will provide scientific justification for the continued development, implementation, and scaling of ICU recovery care programs. Ultimately, such knowledge can 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
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Adults (age ≥45)
  • Admitted to a medical or surgical ICU
  • Treated for ARF (with mechanical ventilation) and/or septic shock (with vasopressors)

排除标准

  • hospice care at discharge or not expected to survive 6 months
  • no access to a computer or electronic device (e.g., tablet, smart phone) with cellular or WiFi connection for a telemedicine clinic visit
  • substance abuse or psych disorder that prevents independent living
  • inability to speak English
  • severe dementia preventing independent living prior to index hospitalization

研究组 & 干预措施

Standard Recovery Conditions (i.e., Control)

No Intervention

Control group participants will proceed with follow-up as determined by the discharging hospital team and directed to use the provided PICS guide to connect with commonly used resources.

Telemedicine ICU Recovery Clinic

Experimental

scheduled telemedicine study visits 3 weeks and 3 months after hospital discharge or return-to-home if discharged to another facility

干预措施: Telemedicine ICU Recovery Clinic Visit (Behavioral)

结局指标

主要结局

Cognitive function - MoCA

时间窗: 6 months

The Montreal Cognitive Assessment-Blind is a 13-item widely used research measure for cognitive function that assesses memory, attention, language, recall, orientation, and abstraction. Test scores range from 0 (worst) to 22 (best) with a score below 18 being abnormal. Individual tasks on the MoCA-Blind are relatively difficult, reflecting less of a ceiling effect than comparable tools. Among widely used global screening measures, the MoCA has been consistently found to be the most sensitive in identifying even mild expressions of cognitive impairment.

Cognitive function - PROMIS

时间窗: 6 months

The PROMIS Cognitive Function is an 8-item patient-reported outcome measure assessing patient-perceived changes in mental acuity, verbal/nonverbal memory, verbal fluency, and concentration. Raw scores are converted to a standardized T-score with a mean of 50. Higher T-scores indicates better cognitive function.

次要结局

  • Mental health - anxiety/depression(6 months)
  • Physical function - quality of life(6 months)
  • Mental health - PTSD(6 months)
  • Physical function - IADL(6 months)
  • Physical function - ADL(6 months)
  • Self management(6 months)
  • Social integration(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 (4)

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