Anticipating Decline and Providing Therapy

Dementia Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182995
• Other study ID #: IRB00102934
• Secondary ID: 1K23AG073529
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: March 2027

Study information

• Verified date: November 2023
• Source: Wake Forest University Health Sciences
• Contact: Taniya Wilson, MS
• Phone: 336-716-6591
• Email: tamwilso[@]wakhealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age 60 and older at time of discharge from medical intensive care unit
• Minimum 72 hour Intensive Care Unit stay in medical 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)
• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Cognitive Impairment, Mild
• Critical Illness
• Dementia
• Post ICU Syndrome

Intervention

Behavioral:
• Usual Care post-Intensive Care Unit (ICU)
routine clinic visits
• Anticipating Decline and Providing Therapy (ADAPT)
routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Perception	semi-structured interviews with participants for feedback about the intervention - this will not be a numerical score	Week 28
Primary	Number of participants in Cognitive Screening Intervention Arm	Number of participants in intervention arm who complete cognitive screening at 6 weeks	Week 6
Secondary	Change in Percentage of participants having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia	percentage of participants adjudicated as having mild cognitive impairment (MCI), probable dementia and the combination of either MCI or probable dementia	Week 28
Secondary	Change in number of Participants between those enrolled and those who were eligible but declined	compare pre-specified baseline characteristics (i.e., age, sex, race, ICU length of stay) between those enrolled and those who were eligible but declined	Week 52
Secondary	Number of eligible participants who complete specialized care plan development visit	Number of eligible participants who complete specialized care plan development visit	up to week 28
Secondary	Change in Modified Caregiver Strain Index (MCSI) Scores	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	Week 28
Secondary	Change in the number of hospitalizations and Emergency Department visits	healthcare utilization will be the number of hospitalizations and Emergency Department (ED) visits	Month 12
Secondary	Change in the Number of neuropsychiatric prescriptions medications	number of neuropsychiatric prescriptions medications will be measured using the electronic health record	Month 12
Secondary	Change in number of new diagnoses of dementia or mild cognitive impairment	new diagnosis of dementia or mild cognitive impairment will be measured using the electronic health record	Month 12
Secondary	Acceptability of Intervention Measure (AIM) Scores	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	Week 28
Secondary	Acceptability of Intervention Appropriateness Measure (IAM) Scores	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	Week 28
Secondary	Acceptability of Feasibility of Intervention measure (FIM) Scores	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	Week 28