ADAPT Program for Post Intensive Care Syndrome

(ADAPT Trial)

Overseen By Darja Ward

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Metastatic cancer, Cirrhosis, Advanced heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to support older adults after they leave the Intensive Care Unit (ICU). The aim is to determine if a special program called Anticipating Decline and Providing Therapy (ADAPT), which includes regular check-ins and cognitive screenings, is more effective than usual follow-up care. It targets individuals aged 60 and older who stayed in the ICU for at least 72 hours and experienced delirium (confusion or disorientation). Participants must have a primary care doctor in the Atrium Health system and be able to speak English. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for older adults.

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 prior data suggests that the ADAPT program is safe for post-ICU patients?

Research has shown that exercise programs like ADAPT can safely and effectively help prevent and manage post-intensive care syndrome (PICS). Studies have found that early rehabilitation, a key component of these programs, improves short-term physical recovery in critically ill patients. Reports indicate no major safety issues with these programs. However, more large studies are needed to fully understand their long-term effects. Overall, patients generally tolerate this kind of therapy well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ADAPT Program for Post Intensive Care Syndrome because it takes a proactive approach by anticipating potential cognitive decline in high-risk older adults after an ICU stay. Unlike standard care, which typically involves routine clinic visits, the ADAPT program includes a validated cognitive screening at 6 weeks and 6 months post-ICU discharge. This allows for early identification and management of cognitive issues, potentially improving long-term outcomes for patients. By focusing on early intervention, the program aims to address cognitive challenges before they become severe, offering a more personalized and targeted approach to post-ICU care.

What evidence suggests that this trial's treatments could be effective for Post Intensive Care Syndrome?

Research has shown that many patients experience post-intensive care syndrome (PICS) after leaving the ICU. A review of 36 studies found that non-drug treatments can help with PICS symptoms, such as problems with thinking, memory, and mental health. In this trial, participants will be assigned to one of two groups. The Anticipating Decline and Providing Therapy (ADAPT) program, one of the study arms, aims to help with these symptoms by offering early screening and support for older adults. Meanwhile, the other arm will receive Usual Care, which involves routine clinic visits. Although more large studies are needed, early rehabilitation efforts have shown promise in improving physical health in the short term for critically ill patients. This suggests that ADAPT could effectively support recovery after leaving the ICU. ^{2 3 5 6 7}

Who Is on the Research Team?

Jessica Palakshappa, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Delirium during ICU stay as determined by positive Confusion Assessment Method (CAM)-ICU score, review of clinical documentation, or discussion with clinical team

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Anticipating Decline and Providing Therapy (ADAPT)
• Usual Care post-Intensive Care Unit (ICU)

Trial Overview 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.

How Is the Trial Designed?

Group I: Anticipating Decline and Providing Therapy (ADAPT) care Experimental Treatment 1 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 Care Active Control 1 Intervention

routine clinic visits

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a review of 128 ICU patient records over two years, 19.5% of patients who died experienced adverse events (AEs), highlighting a significant risk for harm in this vulnerable population.

The study found that over half (54%) of the identified AEs were avoidable, indicating that improved reporting and monitoring systems, like the Global Trigger Tool, could enhance patient safety in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events are common on the intensive care unit: results from a structured record review. Nilsson, L., Pihl, A., Tågsjö, M., et al.[2013]

The study aims to evaluate the effectiveness of an interdisciplinary intervention during the post-ICU recovery phase for patients with multiple organ dysfunction syndrome, highlighting the importance of continuity of care by intensivists.

This research will be conducted as a prospective, randomized, multicenter trial, which will provide robust data on the impact of such interventions on medium-term medical outcomes for ICU patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ulysses network: an approach to integral post-ICU treatment of patients with multiple organ dysfunction syndrome]. Nolla-Salas, M., Monmany-Roca, J., Vázquez-Mata, G.[2019]

Post-intensive care unit syndrome (PICS) affects 10-36% of children after discharge from pediatric intensive care, leading to cognitive, physical, and psychosocial impairments.

Preventing and managing PICS requires a multidisciplinary approach focused on early identification and tailored care plans, as multiple risk factors contribute to its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life after paediatric intensive care unit. Hlophe, ST., Masekela, R.[2021]

Follow-up consultations for ICU survivors may significantly reduce the risk of new onset PTSD within 3-6 months after discharge, based on data from two trials involving 374 patients.

However, these consultations did not show any impact on quality of life or other measured outcomes, indicating that while they may help with PTSD, they do not address all aspects of recovery for ICU survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. Jensen, JF., Thomsen, T., Overgaard, D., et al.[2022]

The PINA study is a pilot randomized controlled trial involving 100 ICU patients aimed at evaluating the feasibility and potential efficacy of a follow-up clinic designed to support ICU survivors suffering from post-intensive care syndrome (PICS).

The intervention includes providing information, consultations, and networking support to improve health-related quality of life (HRQOL) for patients, with outcomes assessed at 6 months post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rohr, M., Brandstetter, S., Bernardi, C., et al.[2021]

The post-discharge critical care transition program (CTP) showed a trend towards reducing ICU readmission rates (0.8% vs. 4.1%), although this was not statistically significant, suggesting potential benefits that warrant further investigation.

Patients in the CTP group experienced significantly improved in-hospital and six-month survival rates, indicating that the program may enhance long-term outcomes for critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of an Intensivist-Led Critical Care Transition Program. Neto, R., Carvalho, M., Paixão, AI., et al.[2022]

Survivors of critical illness often experience post-intensive care syndrome (PICS), which includes a range of physical, cognitive, psychological, and existential health issues, highlighting the need for targeted interventions.

Early physical rehabilitation and case management interventions show promise in improving long-term outcomes for ICU survivors, while late interventions have had mixed results, indicating the importance of timely and tailored care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to Addressing Post-Intensive Care Syndrome among Intensive Care Unit Survivors. A Narrative Review. Brown, SM., Bose, S., Banner-Goodspeed, V., et al.[2020]

A multidisciplinary task force developed 12 strong recommendations and 4 therapy options for addressing post-intensive care syndrome (PICS) in ICU survivors, emphasizing the importance of early mobilization, motor training, and nutrition management.

Regular assessments of physical, cognitive, and psychological health are crucial for effectively treating PICS, highlighting the need for individualized rehabilitation strategies tailored to each patient's specific impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. Renner, C., Jeitziner, MM., Albert, M., et al.[2023]

Survivors of critical illness, both adults and children, often experience significant and lasting physical, cognitive, and psychiatric issues, which can also impact their social health and the well-being of their families.

To address Post-intensive Care Syndrome, a variety of preventive and management strategies are recommended, including early mobilization, physical rehabilitation, and support systems, but more research is needed, especially for pediatric patients, to develop specific monitoring tools and understand long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Post-intensive care syndrome in pediatrics] Toobe, M.[2022]

A study involving 43 patients recovering from intensive care revealed that their rehabilitation goals primarily focused on improving health-related quality of life, including physical rehabilitation and social engagement.

The diverse aspirations of patients highlight the need for personalized post-discharge care plans that consider individual recovery goals and trajectories, which can enhance the overall rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Patients' Goals Within the Intensive Care Unit Rehabilitation Setting. McPeake, JM., Harhay, MO., Devine, H., et al.[2020]

In Portuguese adult intensive care units, three rehabilitation care models were identified: care by ICU staff (22.9%), specialized external teams (25.0%), and a combination of both (52.1%).

Despite the different models of rehabilitation care, there were no significant differences in care availability or patient outcomes, such as length of stay, ventilation time, or mortality rates, indicating that the effectiveness of rehabilitation may not depend on the model used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organization of rehabilitation care in Portuguese intensive care units. Mendes, RMG., Nunes, ML., Pinho, JA., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11128526/

Post intensive care syndrome: A review of clinical symptoms ... Post intensive care syndrome (PICS) is a typical complication of critically ill patients during or after their stay in intensive care unit (ICU).

2. sciencedirect.com sciencedirect.com/science/article/pii/S235201322400111X

Risk prediction models for post-intensive care syndrome of ... This review encompassed 16 studies and identified a range of prediction models for PICS across cognitive, psychological, and physiological impairments.

3. bmjopen.bmj.com bmjopen.bmj.com/content/8/5/e019998

Early rehabilitation to prevent postintensive care syndrome ... Early rehabilitation improved only short-term physical-related outcomes in patients with critical illness. Additional large RCTs are needed.

4. jintensivecare.biomedcentral.com jintensivecare.biomedcentral.com/articles/10.1186/s40560-023-00670-7

Post-intensive care syndrome (PICS): recent updates A recent systematic review of 36 studies with 5,165 patients, evaluated the effectiveness of non-pharmacological interventions for improving ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832291

Post–Intensive Care Syndrome and Caregiver Burden Significant correlations were found between patient PICS and caregiver burden at both 3-month and 12-month follow-ups.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11215031/

From the Intensive Care Unit to Recovery: Managing Post ... Exercise therapy is a highly effective preventive treatment for PICS and post-ICU outcomes. Targeting modifiable risk factors and ...

7. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.201812-913FR

Approaches to Addressing Post–Intensive Care Syndrome ... Extensive studies have identified substantial, persistent impairments in physical, cognitive, and mental health outcomes; limitations in ability ...