Anticipating Decline and Providing Therapy

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Anticipating Decline and Providing Therapy (ADAPT): Post-ICU Cognitive Screening Pilot and Feasibility Randomized Controlled Trial

Conditions
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Dementia, Cognitive Impairment, Post ICU Syndrome, Critical Illness, Cognitive Impairment, Mild

Intervention / Treatment
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* Behavioral: Usual Care post-Intensive Care Unit (ICU)
* Behavioral: Anticipating Decline and Providing Therapy (ADAPT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60 and older at time of discharge from medical intensive care unit Minimum 72 hour Intensive Care Unit stay in medical 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) 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Target sample size is 120 participants, randomized 1:1 to usual care or Anticipating Decline and Providing Therapy (ADAPT) arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>routine clinic visits | Behavioral: Usual Care post-Intensive Care Unit (ICU)<br>* routine clinic visits<br>* Other names: routine clinic visits;|
| Experimental: Anticipating Decline and Providing Therapy (ADAPT) care<br>The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge | Behavioral: Anticipating Decline and Providing Therapy (ADAPT)<br>* routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge<br>* Other names: Post-ICU cognitive screening;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post ICU, Post-ICU Screening, older adults, aging