Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care
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
- 否
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)
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
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
Leanne M Boehm
Assistant Professor
Vanderbilt University
