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Active, Not Recruiting

NCT Number: NCT06182995

Anticipating Decline and Providing Therapy

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care post-Intensive Care Unit (ICU)

Behavioral

routine clinic visits

Other names: routine clinic visits

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

Other names: Post-ICU cognitive screening

Primary outcomes

  1. Number of participants in Cognitive Screening Intervention Arm

    Time frame: Week 6

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

Secondary outcomes

  1. Change in Percentage of participants having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia

    Time frame: Week 28

    percentage of participants adjudicated as having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia

  2. Change in number of Participants between those enrolled and those who were eligible but declined

    Time frame: Week 52

    compare pre-specified baseline characteristics (i.e., age, sex, race, ICU length of stay) between those enrolled and those who were eligible but declined

  3. Number of eligible participants who complete specialized care plan development visit

    Time frame: up to week 28

    Number of eligible participants who complete specialized care plan development visit

  4. Change in Modified Caregiver Strain Index (MCSI) Scores

    Time frame: Week 28

    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

  5. Change in the number of hospitalizations and Emergency Department visits

    Time frame: Month 12

    healthcare utilization will be the number of hospitalizations and Emergency Department (ED) visits

  6. Change in the Number of neuropsychiatric prescriptions medications

    Time frame: Month 12

    number of neuropsychiatric prescriptions medications will be measured using the electronic health record

  7. Change in number of new diagnoses of dementia or mild cognitive impairment

    Time frame: Month 12

    new diagnosis of dementia or mild cognitive impairment will be measured using the electronic health record

  8. Acceptability of Intervention Measure (AIM) Scores

    Time frame: Week 28

    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

  9. Acceptability of Intervention Appropriateness Measure (IAM) Scores

    Time frame: Week 28

    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

  10. Acceptability of Feasibility of Intervention measure (FIM) Scores

    Time frame: Week 28

    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

Other outcomes

  1. Qualitative Perception

    Time frame: Week 28

    semi-structured interviews with participants for feedback about the intervention - this will not be a numerical score

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: ADAPT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 27, 2023
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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