Anticipating Decline and Providing Therapy (NCT06182995) | Clinical Trial Compass
CompletedNot Applicable
Anticipating Decline and Providing Therapy
United States109 participantsStarted 2024-03-08
Plain-language summary
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).
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on cognitive screening after ICU stays — given my situation, does my doctor think I'm at risk for the kind of cognitive decline or post-ICU syndrome this study was trying to catch early?
2Since this trial has already completed recruitment, would my doctor be able to access any published results or findings that might be relevant to my care or monitoring plan?
3The trial was measuring how many people participated in a cognitive screening intervention — what does that kind of screening actually involve, and is it something my doctor could offer me outside of a clinical trial?
4Post-ICU syndrome can affect memory and thinking even in people who didn't seem severely ill — should I be asking for a formal cognitive assessment now, and how would my doctor decide which screening tool to use?
5Are there other ongoing trials or standard-of-care approaches for monitoring mild cognitive impairment after critical illness that my doctor thinks might be a better fit for me at this point?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants in Cognitive Screening Intervention Arm