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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AG073529 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | routine clinic visits |
|
| Anticipating Decline and Providing Therapy (ADAPT) care | Experimental | The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care post-Intensive Care Unit (ICU) | Behavioral | routine clinic visits |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants in Cognitive Screening Intervention Arm | Number of participants in intervention arm who complete cognitive screening at 6 weeks | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of participants having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia | percentage of participants adjudicated as having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia | Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Perception | semi-structured interviews with participants for feedback about the intervention - this will not be a numerical score | Week 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Palakshappa, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2025 | Mar 26, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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Target sample size is 120 participants, randomized 1:1 to usual care or Anticipating Decline and Providing Therapy (ADAPT) arm.
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| Anticipating Decline and Providing Therapy (ADAPT) | Behavioral | routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge |
|
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| Change in number of Participants between those enrolled and those who were eligible but declined |
compare pre-specified baseline characteristics (i.e., age, sex, race, ICU length of stay) between those enrolled and those who were eligible but declined |
| Week 52 |
| Number of eligible participants who complete specialized care plan development visit | Number of eligible participants who complete specialized care plan development visit | up to week 28 |
| Change in Modified Caregiver Strain Index (MCSI) Scores | 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 | Week 28 |
| Change in the number of hospitalizations and Emergency Department visits | healthcare utilization will be the number of hospitalizations and Emergency Department (ED) visits | Month 12 |
| Change in the Number of neuropsychiatric prescriptions medications | number of neuropsychiatric prescriptions medications will be measured using the electronic health record | Month 12 |
| Change in number of new diagnoses of dementia or mild cognitive impairment | new diagnosis of dementia or mild cognitive impairment will be measured using the electronic health record | Month 12 |
| Acceptability of Intervention Measure (AIM) Scores | 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 | Week 28 |
| Acceptability of Intervention Appropriateness Measure (IAM) Scores | 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 | Week 28 |
| Acceptability of Feasibility of Intervention measure (FIM) Scores | 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 | Week 28 |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |