Clinical trial NCT06182995: Anticipating Decline and Providing Therapy
Official title: Anticipating Decline and Providing Therapy (ADAPT): Post-ICU Cognitive Screening Pilot and Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Dementia
Post ICU Syndrome
Critical Illness
Cognitive Impairment, Mild
Keywords: Post ICU
Post-ICU Screening
older adults
aging
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-12-27
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Target sample size is 120 participants, randomized 1:1 to usual care or Anticipating Decline and Providing Therapy (ADAPT) arm.
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants in Cognitive Screening Intervention Arm
timeFrame: Week 6
Secondary outcomes:
measure: Change in Percentage of participants having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia
timeFrame: Week 28
measure: Change in number of Participants between those enrolled and those who were eligible but declined
timeFrame: Week 52
measure: Number of eligible participants who complete specialized care plan development visit
timeFrame: up to week 28
measure: Change in Modified Caregiver Strain Index (MCSI) Scores
timeFrame: Week 28
measure: Change in the number of hospitalizations and Emergency Department visits
timeFrame: Month 12
measure: Change in the Number of neuropsychiatric prescriptions medications
timeFrame: Month 12
measure: Change in number of new diagnoses of dementia or mild cognitive impairment
timeFrame: Month 12
measure: Acceptability of Intervention Measure (AIM) Scores
timeFrame: Week 28
measure: Acceptability of Intervention Appropriateness Measure (IAM) Scores
timeFrame: Week 28
measure: Acceptability of Feasibility of Intervention measure (FIM) Scores
timeFrame: Week 28
Other outcomes:
measure: Qualitative Perception
timeFrame: Week 28
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jessica Palakshappa, MD
role: PRINCIPAL_INVESTIGATOR
References: