Anticipating Decline and Providing Therapy

NCT ID: NCT06182995

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2026-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

routine clinic visits

Group Type: ACTIVE_COMPARATOR

Usual Care post-Intensive Care Unit (ICU)

Intervention Type: BEHAVIORAL

routine clinic visits

Anticipating Decline and Providing Therapy (ADAPT) care

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

Group Type: EXPERIMENTAL

Anticipating Decline and Providing Therapy (ADAPT)

Intervention Type: BEHAVIORAL

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

Interventions

Usual Care post-Intensive Care Unit (ICU)

routine clinic visits

Intervention Type: BEHAVIORAL

Anticipating Decline and Providing Therapy (ADAPT)

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

Intervention Type: BEHAVIORAL

Other Intervention Names

routine clinic visits; Post-ICU cognitive screening

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Palakshappa, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Darja Ward

Role: CONTACT

darward@wakhealth.edu

336-716-8898

Jessica Palakshappa, MD

Role: CONTACT

jpalaksh@wakehealth.edu

336-716-8465

Facility Contacts

Darja Ward

Role: primary

darward@wakehealth.edu

336-716-8898

Lori A Flores, NP

Role: backup

lflores@wakehealth.edu

336-713-0008

Other Identifiers

1K23AG073529

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00102934

Identifier Type: -

Identifier Source: org_study_id