Anticipating Decline and Providing Therapy (ADAPT)

Wake Forest University (WFU)

Status: Enrolling

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

Treatments: Behavioral: Usual Care post-Intensive Care Unit (ICU); Behavioral: Anticipating Decline and Providing Therapy (ADAPT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06182995

IRB00102934

1K23AG073529 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

routine clinic visits

Treatment:

Behavioral: Usual Care post-Intensive Care Unit (ICU)

Anticipating Decline and Providing Therapy (ADAPT) care

Experimental group

Description:

The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge

Treatment:

Behavioral: Anticipating Decline and Providing Therapy (ADAPT)