Clinical trial NCT06014931: Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care
Official title: Telehealth-enhanced Patient-oriented Recovery Trajectory After Intensive Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-intensive Care Syndrome
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Ohio State University
First posted: 2023-08-28
Enrollment: 202
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intact cognitive skills are necessary for independent living, going to work, and managing finances, and any loss of cognitive skills places a burden on society akin to what is seen with Alzheimer's Disease and Related Dementias. The TelePORT Study (Telehealth-Enhanced Patient-Oriented Recovery Trajectories after Intensive Care) is the first post-intensive care syndrome longitudinal long-term cognitive impairment intervention study. The societal effect from long-term cognitive impairment after critical illness is great as many of these patients are employable adults or functional retirees.

Detailed description: Up to 80% of Intensive Care Unit (ICU) survivors experience cognitive, physical, mental, and socioeconomic impairments, known as Post-Intensive Care Syndrome (PICS), that can last months to years following critical illness and lead to significant reductions in quality of life. Among historical cohorts of acute respiratory distress syndrome and sepsis survivors, as many as 80% demonstrate PICS-related acquired dementia. Likewise, in a broad group of ICU survivors in all adult age groups, 33% to 50% have acquired dementia. ICU Recovery Clinics (ICU-RC) are a feasible and promising intervention to address multifactorial PICS impairments collaboratively, but in-person access is limited. There is an unmet need to study the efficacy of clinics with large cohorts that apply alternative delivery strategies to enhance availability and reach. Older adult (age \>=45) ICU survivor is at a combined risk for long-term cognitive impairment (LTCI) among other PICS impairments, and the ideal population to first address this knowledge gap. The investigators hypothesize that a collaborative telemedicine-delivered interdisciplinary ICU-RC intervention effectively identifies and improves LTCI, physical and mental health dysfunction, social integration, and self-management behaviors vs. a control condition with follow-up chosen by the discharge team. Therefore, in a sample of older septic shock and acute respiratory failure survivors, the investigators aim to examine the efficacy of telemedicine ICU-RC services vs. control follow-up chosen by the discharge team in identifying PICS impairments and improving cognitive, physical, and mental health function; and social integration and self-management behaviors at 6 months after hospital discharge. This willl be achieved via a randomized controlled trial of 202 patients randomized 1:1 with age stratification to telemedicine ICU-RC or control (101 per group). Telemedicine recipients will receive a minimum of 2 ICU-RC visits within 3 months of hospital discharge or return to home if discharged to another institution, with additional follow-up determined by the severity of PICS impairment. Cognitive, mental health, and physical outcomes will be measured using the Long-term Core Outcome Measurement Set for ICU survivors in addition to the Social Network Index and Patient Activation Measure. Measures are timed to assess pre-hospital, 1-week post-discharge, and 6-month post-discharge functioning trajectories. This research will provide scientific justification for the continued development, implementation, and scaling of ICU recovery care programs. Ultimately, such knowledge can improve the quality of life for millions of ICU survivors and their family members.

Eligibility criteria: Inclusion Criteria:

* Adults (age ≥45)
* Admitted to a medical or surgical ICU
* Treated for ARF (with mechanical ventilation) and/or septic shock (with vasopressors)

Exclusion Criteria:

* hospice care at discharge or not expected to survive 6 months
* no access to a computer or electronic device (e.g., tablet, smart phone) with cellular or WiFi connection for a telemedicine clinic visit
* substance abuse or psych disorder that prevents independent living
* inability to speak English
* severe dementia preventing independent living prior to index hospitalization

Primary outcomes:
measure: Cognitive function - MoCA
timeFrame: 6 months
measure: Cognitive function - PROMIS
timeFrame: 6 months
Secondary outcomes:
measure: Physical function - ADL
timeFrame: 6 months
measure: Physical function - IADL
timeFrame: 6 months
measure: Physical function - quality of life
timeFrame: 6 months
measure: Mental health - PTSD
timeFrame: 6 months
measure: Mental health - anxiety/depression
timeFrame: 6 months
measure: Social integration
timeFrame: 6 months
measure: Self management
timeFrame: 6 months
Other outcomes:
measure: Post-Traumatic Growth
timeFrame: 6 months
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Leanne M Boehm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boehm LM, Danesh V, Eaton TL, McPeake J, Pena MA, Bonnet KR, Stollings JL, Jones AC, Schlundt DG, Sevin CM. Multidisciplinary ICU Recovery Clinic Visits: A Qualitative Analysis of Patient-Provider Dialogues. Chest. 2023 Apr;163(4):843-854. doi: 10.1016/j.chest.2022.10.001. Epub 2022 Oct 13.
citation: Boehm LM, Danesh V, LaNoue M, Trochez RJ, Jones AC, Kimpel CC, Sevin CM. Factors Influencing Engagement with in-Person Intensive Care Unit Recovery Clinic Services. J Intensive Care Med. 2023 Apr;38(4):375-381. doi: 10.1177/08850666221127154. Epub 2022 Sep 21.