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

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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

How 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. ^{1 2 3 10 11}

Research Team

Jessica Palakshappa, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Impact of an Intensivist-Led Critical Care Transition Program. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Exploring Patients' Goals Within the Intensive Care Unit Rehabilitation Setting. [2020]

5. Brazil pubmed.ncbi.nlm.nih.gov

Organization of rehabilitation care in Portuguese intensive care units. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events are common on the intensive care unit: results from a structured record review. [2013]

7. Spain pubmed.ncbi.nlm.nih.gov

[Ulysses network: an approach to integral post-ICU treatment of patients with multiple organ dysfunction syndrome]. [2019]

8. South Africa pubmed.ncbi.nlm.nih.gov

Life after paediatric intensive care unit. [2021]

9. England 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Approaches to Addressing Post-Intensive Care Syndrome among Intensive Care Unit Survivors. A Narrative Review. [2020]

11. Argentina pubmed.ncbi.nlm.nih.gov

[Post-intensive care syndrome in pediatrics] [2022]