Anticipating Decline and Providing Therapy (ADAPT): Post-ICU Cognitive Screening Pilot and Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Number of participants in Cognitive Screening Intervention Arm
研究概览
简要总结
This pilot feasibility study will be a randomized control trial of usual care following Intensive Care Unit (ICU) discharge compared to the Anticipating Decline and Providing Therapy (ADAPT) screening and support intervention. The trial aims to enroll 120 older adults (age 60 or older).
详细描述
Anticipating Decline and Providing Therapy (ADAPT) is a program designed to support the implementation of a routine post-ICU cognitive impairment screening and support intervention. The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge. Patients with a screening assessment that may be consistent with cognitive impairment or dementia will receive additional resources including a specialized care plan developed by the Sticht Center for Healthy Aging and Alzheimer's Prevention. The specialized care plan is adapted from a health system-based dementia care intervention and designed to support post-ICU cognitive concerns. It was adapted with input from geriatrics, intensive care, and outpatient primary care clinicians. Also conducted are semi-structured interviews with 22 older adult ICU survivors and 6 primary care physicians to elicit preferences and the intervention was further adapted based on these results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 and older at time of discharge from intensive care unit
- •Minimum 72 hour Intensive Care Unit stay in an ICU at Atrium Health Wake Forest Baptist
- •Delirium during ICU stay as determined by positive Confusion Assessment Method (CAM)-ICU score, review of clinical - documentation, or discussion with clinical team
- •Primary care provider in the Atrium Health Wake Forest system or intention to follow with Primary Care Physician in Atrium Health system
- •English speaking
排除标准
- •Death during initial hospitalization and/or discharge to Hospice
- •Life-expectancy < 6 months from pre-existing illness (defined as diagnosis of metastatic cancer, cirrhosis, advanced heart failure, prior palliative care referral)
- •Acute Traumatic Brain Injury
- •Continued residence in skilled nursing facility or rehab that prevents ability to complete study telephone call at time of first cognitive screen attempt
- •Prior history of dementia in electronic health record
- •Language or communication barrier that prohibits intervention participation
- •Participant cannot identify family or caregiver contact or family/caregiver unwilling to participate
- •Subject or legally authorized representative (LAR) decline consent
- •Unstable telephone service for contact after hospital discharge
- •Primary residence outside of North Carolina
研究组 & 干预措施
Usual Care
routine clinic visits
干预措施: Usual Care post-Intensive Care Unit (ICU) (Behavioral)
Anticipating Decline and Providing Therapy (ADAPT) care
The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge
干预措施: Anticipating Decline and Providing Therapy (ADAPT) (Behavioral)
结局指标
主要结局
Number of participants in Cognitive Screening Intervention Arm
时间窗: Week 6
Number of participants in intervention arm who complete cognitive screening at 6 weeks
次要结局
- Acceptability of Intervention Measure (AIM) Scores(Week 28)
- Change in Percentage of participants having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia(Week 28)
- Change in the Number of neuropsychiatric prescriptions medications(Month 12)
- Change in number of new diagnoses of dementia or mild cognitive impairment(Month 12)
- Change in number of Participants between those enrolled and those who were eligible but declined(Week 52)
- Number of eligible participants who complete specialized care plan development visit(up to week 28)
- Change in Modified Caregiver Strain Index (MCSI) Scores(Week 28)
- Change in the number of hospitalizations and Emergency Department visits(Month 12)
- Acceptability of Intervention Appropriateness Measure (IAM) Scores(Week 28)
- Acceptability of Feasibility of Intervention measure (FIM) Scores(Week 28)