Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT06182995
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).
This study is active but is not currently recruiting participants.
60 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
routine clinic visits
Other names: routine clinic visits
routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge
Other names: Post-ICU cognitive screening
Time frame: Week 6
Number of participants in intervention arm who complete cognitive screening at 6 weeks
Time frame: Week 28
percentage of participants adjudicated as having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia
Time frame: Week 52
compare pre-specified baseline characteristics (i.e., age, sex, race, ICU length of stay) between those enrolled and those who were eligible but declined
Time frame: up to week 28
Number of eligible participants who complete specialized care plan development visit
Time frame: Week 28
the modified caregiver strain index will be assessed via telephone call to identified caregiver or care partner in both groups - a 13-question tool that measures strain related to care provision - Scoring is 2 points for each 'yes', and 1 point for each 'sometimes' response. The higher the score, the higher the level of caregiver strain - range of 13-26
Time frame: Month 12
healthcare utilization will be the number of hospitalizations and Emergency Department (ED) visits
Time frame: Month 12
number of neuropsychiatric prescriptions medications will be measured using the electronic health record
Time frame: Month 12
new diagnosis of dementia or mild cognitive impairment will be measured using the electronic health record
Time frame: Week 28
The Acceptability of Intervention Measure (AIM) - Response Scale - 4 item scales. Each item will be measured on a 5 point Likert scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree - The score is calculated mean. Higher scores reflect higher measure of acceptability
Time frame: Week 28
Intervention Appropriateness Measure (IAM) - Response Scale - 4 item scales. Each item will be measured on a 5 point Likert scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree - The score is calculated mean. Higher scores reflect higher measure of appropriateness
Time frame: Week 28
The Acceptability of Feasibility of Intervention Measure (FIM) - Response Scale - 4 item scales. Each item will be measured on a 5 point Likert scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree - The score is calculated mean. Higher scores reflect higher measure of feasibility
Time frame: Week 28
semi-structured interviews with participants for feedback about the intervention - this will not be a numerical score
Wake Forest University Health Sciences
Other
Anticipating Decline and Providing Therapy (ADAPT): Post-ICU Cognitive Screening Pilot and Feasibility Randomized Controlled Trial
Acronym: ADAPT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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