ADAPT Program for Post Intensive Care Syndrome
(ADAPT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJessica Palakshappa, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Metastatic cancer, Cirrhosis, Advanced heart failure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the ADAPT treatment for Post Intensive Care Syndrome?
Research suggests that follow-up consultations and critical care transition programs can help ICU survivors by reducing readmissions and improving survival rates, which may indicate that structured post-ICU care like ADAPT could be beneficial.
12345Is the ADAPT Program for Post Intensive Care Syndrome safe for humans?
The research articles do not provide specific safety data for the ADAPT Program or similar interventions for Post Intensive Care Syndrome, but they highlight the importance of careful management and follow-up care for ICU survivors to prevent complications.
16789How is the ADAPT treatment different from other treatments for post-intensive care syndrome?
The ADAPT treatment is unique because it focuses on anticipating decline and providing therapy early, which may include very early physical rehabilitation and case management interventions, unlike standard care that often involves later interventions. This proactive approach aims to improve long-term outcomes for ICU survivors by addressing physical, cognitive, and psychological health issues associated with post-intensive care syndrome.
1231011Eligibility Criteria
This trial is for older adults aged 60 or above who have been discharged from the ICU and may be at risk of post-intensive care syndrome, dementia, or other cognitive impairments. Specific eligibility details are not provided.Inclusion Criteria
I am 60 years old or older and was recently in the ICU.
I stayed in the ICU at Atrium Health Wake Forest Baptist for at least 72 hours.
English speaking
+2 more
Exclusion Criteria
Participant cannot identify family or caregiver contact or family/caregiver unwilling to participate
I live in a facility that makes it hard for me to take part in study calls.
Unstable telephone service for contact after hospital discharge
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Cognitive Screening
Participants receive a routine validated cognitive screen at 6 weeks post-ICU discharge
6 weeks
1 visit (in-person)
Specialized Care Plan Development
Eligible participants complete a specialized care plan development visit
up to 28 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Participant Groups
The study compares usual post-ICU care with a new intervention called ADAPT which includes screening and support to prevent cognitive decline. It's a randomized control trial aiming to enroll 120 participants.
2Treatment groups
Experimental Treatment
Active Control
Group I: Anticipating Decline and Providing Therapy (ADAPT) careExperimental Treatment1 Intervention
The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge
Group II: Usual CareActive Control1 Intervention
routine clinic visits
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atrium Health Wake Forest BaptistWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. [2022]To evaluate the impact of routine follow-up consultations versus standard of care for intensive care unit (ICU) survivors.
The Impact of an Intensivist-Led Critical Care Transition Program. [2022]Evaluate the impact of a post-discharge critical care transition program (CTP) on intensive care unit (ICU) readmission, in-hospital mortality, and six-month survival.
Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. [2023]Intensive Care Unit (ICU) survivors often experience several impairments in their physical, cognitive, and psychological health status, which are labeled as post-intensive care syndrome (PICS). The aim of this work is to develop a multidisciplinary and -professional guideline for the rehabilitative therapy of PICS.
Exploring Patients' Goals Within the Intensive Care Unit Rehabilitation Setting. [2020]The number of patients surviving critical care is increasing. Quality of life after critical care is known to be poor for some patients. The evidence base for effective rehabilitation interventions in the period following a stay in an intensive care unit is limited.
Organization of rehabilitation care in Portuguese intensive care units. [2018]To describe the different rehabilitation care models in practice in Portuguese adult intensive care units.
Adverse events are common on the intensive care unit: results from a structured record review. [2013]Intensive care is advanced and highly technical, and it is essential that, despite this, patient care remains safe and of high quality. Adverse events (AEs) are supposed to be reported to internal quality control systems by health-care providers, but many are never reported. Patients on the intensive care unit (ICU) are at special risk for AEs. Our aim was to identify the incidence and characteristics of AEs in patients who died on the ICU during a 2-year period.
[Ulysses network: an approach to integral post-ICU treatment of patients with multiple organ dysfunction syndrome]. [2019]The concept of continuity of care by intensivists as an element of quality control in the medical care of Intensive Care Unit (ICU) patients surviving multiple organ dysfunction syndrome has led to a rethinking of the ICU model in recent years. We discuss the rationale to design and implement a hospital-based, prospective, randomized, multicenter Intervention/Control study in order to estimate the impact of an interdisciplinary intervention during the post-ICU recovery phase on medium-term medical outcomes in ICU patients with multiple organ dysfunction.
Life after paediatric intensive care unit. [2021]Advances in critical care medicine have led to reduced mortality but increased morbidity. Post-intensive care unit syndrome (PICS) develops after critical illness and presents as cognitive, physical and/or psychosocial impairments. PICS is prevalent in 10 - 36% of patients after discharge from paediatric intensive care unit. Multiple risk factors are associated with PICS, but there is no single causal factor. Factors range from clinical illnesses to intensive care intervention. The care plan should be aimed at prevention, early identification and post-ICU management of PICS by a multidisciplinary team.
Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial. [2021]Intensive care unit (ICU) survivors often suffer from cognitive, physical and mental impairments, known as post-intensive care syndrome (PICS). ICU follow-up clinics may improve aftercare of these patients. There is a lack of evidence whether or which concept of an ICU follow-up clinic is effective. Within the PINA study, a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomised controlled trial (RCT), primarily to evaluate the feasibility and additionally the potential efficacy.
Approaches to Addressing Post-Intensive Care Syndrome among Intensive Care Unit Survivors. A Narrative Review. [2020]Critical illness can be lethal and devastating to survivors. Improvements in acute care have increased the number of intensive care unit (ICU) survivors. These survivors confront a range of new or worsened health states that collectively are commonly denominated post-intensive care syndrome (PICS). These problems include physical, cognitive, psychological, and existential aspects, among others. Burgeoning interest in improving long-term outcomes for ICU survivors has driven an array of potential interventions to improve outcomes associated with PICS. To date, the most promising interventions appear to relate to very early physical rehabilitation. Late interventions within aftercare and recovery clinics have yielded mixed results, although experience in heart failure programs suggests the possibility that very early case management interventions may help improve intermediate-term outcomes, including mortality and hospital readmission. Predictive models have tended to underperform, complicating study design and clinical referral. The complexity of the health states associated with PICS suggests that careful and rigorous evaluation of multidisciplinary, multimodality interventions-tied to the specific conditions of interest-will be required to address these important problems.
[Post-intensive care syndrome in pediatrics] [2022]The term “Post-intensive care syndrome” describe new impairments after critical illness, that worsen physical, cognitive, or mental health, and persist after acute care hospitalization.