Anticipating Decline and Providing Therapy

NCT06182995 | Completed DMC

• 2 other identifiers: IRB001029341K23AG073529
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Post ICU; Post-ICU Screening; older adults; aging

Outcome Measures

Primary Outcomes (1)

• Number of participants in Cognitive Screening Intervention Arm

  Number of participants in intervention arm who complete cognitive screening at 6 weeks

  Week 6

Secondary Outcomes (10)

• Change in Percentage of participants 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

  Week 52

• Number of eligible participants who complete specialized care plan development visit

  up to week 28

• Change in Modified Caregiver Strain Index (MCSI) Scores

  Week 28

• Change in the number of hospitalizations and Emergency Department visits

  Month 12

Other Outcomes (1)

• Qualitative Perception

  Week 28

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

routine clinic visits

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

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

Behavioral: Anticipating Decline and Providing Therapy (ADAPT)

Interventions

Usual Care post-Intensive Care Unit (ICU) BEHAVIORAL

routine clinic visits

Also known as: routine clinic visits

Usual Care

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

Also known as: Post-ICU cognitive screening

Anticipating Decline and Providing Therapy (ADAPT) care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Critical Illness

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica Palakshappa, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Target sample size is 120 participants, randomized 1:1 to usual care or Anticipating Decline and Providing Therapy (ADAPT) arm.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 27, 2023
• Study Start: March 8, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)